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idK171742_s0_e2000 | K171742.txt | panel | Immunology (82) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare... |
idK171742_s0_e2000 | K171742.txt | indications for use | Same as Intended Uses | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare Diagn... |
idK171742_s0_e2000 | K171742.txt | applicant | Siemens Healthcare Diagnostics Products GmbH | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare ... |
idK171742_s6000_e8000 | K171742.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. | ... |
idK171742_s6000_e8000 | K171742.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK151767_s0_e2000 | K151767.txt | purpose for submission | New devices | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: Sieme... |
idK151767_s0_e2000 | K151767.txt | measurand | Sodium, Potassium, Chloride, Albumin | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: Sieme... |
idK151767_s0_e2000 | K151767.txt | type of test | Quantitative, photometry, and ion selective multisensors for electrolytes | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: S... |
idK151767_s0_e2000 | K151767.txt | panel | Chemistry (75) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant:... |
idK151767_s0_e2000 | K151767.txt | intended use | See Indications for use below | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: S... |
idK151767_s0_e2000 | K151767.txt | predicate device name | Siemens ADVIA 1800 Chemistry System including ISE and Albumin BCP Assays | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: Sieme... |
idK151767_s0_e2000 | K151767.txt | applicant | Siemens Healthcare Diagnostics Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: ... |
idK151767_s8000_e10000 | K151767.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK151767_s8000_e10000 | K151767.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK182472_s0_e2000 | K182472.txt | purpose for submission | To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: N... |
idK182472_s0_e2000 | K182472.txt | type of test | The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert I... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: ... |
idK182472_s0_e2000 | K182472.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand:... |
idK182472_s0_e2000 | K182472.txt | product code | PMN: Assayed external control material for microbiology nucleic acid amplification | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand:... |
idK182472_s0_e2000 | K182472.txt | panel | 83 - Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand... |
idK182472_s0_e2000 | K182472.txt | intended use | The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on t... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: ... |
idK182472_s0_e2000 | K182472.txt | predicate device name | Bio-Rad Amplichek II | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: N... |
idK182472_s0_e2000 | K182472.txt | applicant | Microbiologics, Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand:... |
idK182472_s0_e2000 | K182472.txt | proprietary and established names | Cepheid Xpert GBS LB Control Panel | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: Nucleic... |
idK182472_s0_e2000 | K182472.txt | regulation section | 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: ... |
idK182472_s2000_e4000 | K182472.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | ... |
idK182472_s2000_e4000 | K182472.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK143548_s0_e2000 | K143548.txt | purpose for submission | New device | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia... |
idK143548_s0_e2000 | K143548.txt | measurand | Capillary whole blood glucose from the fingertip | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia... |
idK143548_s0_e2000 | K143548.txt | type of test | Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Triv... |
idK143548_s0_e2000 | K143548.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Tri... |
idK143548_s0_e2000 | K143548.txt | panel | Clinical Chemistry (75) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Tr... |
idK143548_s0_e2000 | K143548.txt | intended use | See indication(s) for use below. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Triv... |
idK143548_s0_e2000 | K143548.txt | predicate device name | Bayer Ascensia Contour Blood Glucose Monitoring System | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia... |
idK143548_s0_e2000 | K143548.txt | applicant | Trividia Health, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Tri... |
idK143548_s0_e2000 | K143548.txt | proprietary and established names | TRUE METRIX™ GO Blood Glucose Monitoring System | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia Heal... |
idK143548_s0_e2000 | K143548.txt | regulation section | 21 CFR 862.1345, Glucose test system | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Triv... |
idK143548_s4000_e6000 | K143548.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK143548_s4000_e6000 | K143548.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK172913_s0_e2000 | K172913.txt | purpose for submission | To obtain clearance for a new device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II an... |
idK172913_s0_e2000 | K172913.txt | measurand | Factor II and Factor V | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II an... |
idK172913_s0_e2000 | K172913.txt | type of test | Genotyping test | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II a... |
idK172913_s0_e2000 | K172913.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II ... |
idK172913_s0_e2000 | K172913.txt | panel | Hematology (81) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II... |
idK172913_s0_e2000 | K172913.txt | applicant | Roche Molecular Systems, Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II ... |
idK172913_s0_e2000 | K172913.txt | proprietary and established names | cobas® Factor II and Factor V Test | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II and Fact... |
idK172913_s0_e2000 | K172913.txt | regulation section | 21 CFR 84.7280; Factor V Leiden DNA Mutation Detection Systems | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II a... |
idK172913_s6000_e8000 | K172913.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. | >T, 20218A>G, 20221C>T, 1689G>A, 1690C>T, 1692A>C and 1696A>G) in the probe binding regions of the cobas Factor II and Factor V Test were tested. The Factor II SNP plasmids and the Factor V SNP plasmids were wild type at positions 20210 and 1691, respectively. Each SNP plasmid DNA was tested alone, and in... |
idK172913_s6000_e8000 | K172913.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | 9C>T, 20218A>G, 20221C>T, 1689G>A, 1690C>T, 1692A>C and 1696A>G) in the probe binding regions of the cobas Factor II and Factor V Test were tested. The Factor II SNP plasmids and the Factor V SNP plasmids were wild type at positions 20210 and 1691, respectively. Each SNP plasmid DNA was tested alone, and ... |
idK181915_s0_e2000 | K181915.txt | purpose for submission | New device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names: ... |
idK181915_s0_e2000 | K181915.txt | measurand | Glycosylated hemoglobin (HbA1c) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names: ... |
idK181915_s0_e2000 | K181915.txt | type of test | Quantitative Immunoassay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names:... |
idK181915_s0_e2000 | K181915.txt | intended use | See indications for use below. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names:... |
idK181915_s0_e2000 | K181915.txt | predicate device name | SD A1cCare System and SD A1cCare Spoit Type Test Kit | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names: ... |
idK181915_s0_e2000 | K181915.txt | applicant | iXensor Co., LTD. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names... |
idK181915_s0_e2000 | K181915.txt | proprietary and established names | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names: PixoTe... |
idK181915_s4000_e6000 | K181915.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK181915_s4000_e6000 | K181915.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK161619_s0_e2000 | K161619.txt | purpose for submission | The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vaginal swabs under K151565. The original clinical study in K151565 included both male and female clinical sp... | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vag... |
idK161619_s0_e2000 | K161619.txt | measurand | Trichomonas vaginalis (TV) DNA | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vag... |
idK161619_s0_e2000 | K161619.txt | type of test | Nucleic acid amplification test using real-time polymerase chain reaction (PCR) | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected v... |
idK161619_s0_e2000 | K161619.txt | classification | Class II | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collect... |
idK161619_s0_e2000 | K161619.txt | panel | Microbiology (83) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collec... |
idK161619_s0_e2000 | K161619.txt | predicate device name | Cepheid Xpert TV assay | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vag... |
idK161619_s0_e2000 | K161619.txt | applicant | Cepheid | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collect... |
idK161619_s0_e2000 | K161619.txt | regulation section | 21 CFR 866.3860, Trichomonas vaginalis nucleic acid assay | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected v... |
idK161619_s4000_e6000 | K161619.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | iol f. Assay cut-off: The studies determining the assay cut-off were previousl... |
idK161619_s4000_e6000 | K161619.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | stradiol f. Assay cut-off: The studies determining the assay cut-off were prev... |
idK161619_s4000_e6000 | K161619.txt | applicant | Cepheid | adiol f. Assay cut-off: The studies determining the assay cut-off were previou... |
idK162895_s0_e2000 | K162895.txt | purpose for submission | New device | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STAT Im... |
idK162895_s0_e2000 | K162895.txt | measurand | Cardiac troponin T (cTnT) | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STAT Im... |
idK162895_s0_e2000 | K162895.txt | type of test | Quantitative immunoassay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STA... |
idK162895_s0_e2000 | K162895.txt | panel | Chemistry | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 S... |
idK162895_s0_e2000 | K162895.txt | intended use | See Indication(s) for use. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STA... |
idK162895_s0_e2000 | K162895.txt | predicate device name | Elecsys Troponin T STAT Assay, Elecsys Troponin T CalSet, Elecsys PreciControl Troponin, Elecsys CA 15-3 CalCheck 5 | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STAT Im... |
idK162895_s0_e2000 | K162895.txt | applicant | Roche Diagnostics | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 ST... |
idK162895_s8000_e10000 | K162895.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK162895_s8000_e10000 | K162895.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK181092_s0_e2000 | K181092.txt | purpose for submission | To obtain a substantial equivalence determination for the CHROMID CARBA Agar | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Sele... |
idK181092_s0_e2000 | K181092.txt | measurand | Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Sele... |
idK181092_s0_e2000 | K181092.txt | type of test | Selective and differential culture medium | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Sel... |
idK181092_s0_e2000 | K181092.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Se... |
idK181092_s0_e2000 | K181092.txt | product code | JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Se... |
idK181092_s0_e2000 | K181092.txt | panel | 83: Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: S... |
idK181092_s0_e2000 | K181092.txt | predicate device name | bioMérieux CHROMID VRE agar | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Sele... |
idK181092_s0_e2000 | K181092.txt | applicant | bioMérieux SA | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Se... |
idK181092_s0_e2000 | K181092.txt | proprietary and established names | CHROMID CARBA agar (CARB) | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Selective ... |
idK181092_s0_e2000 | K181092.txt | regulation section | 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Sel... |
idK181092_s10000_e12000 | K181092.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | Table 7. A summary of the isolates tested is shown in Table 10. Each contrived specimen was spiked with a unique bacteria... |
idK181092_s10000_e12000 | K181092.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | depicted in Table 7. A summary of the isolates tested is shown in Table 10. Each contrived specimen was spiked with a uni... |
idK161258_s0_e2000 | K161258.txt | purpose for submission | New Device | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Propr... |
idK161258_s0_e2000 | K161258.txt | measurand | Anti-Neutrophil Cytoplasmic Antibodies (ANCA) | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Propr... |
idK161258_s0_e2000 | K161258.txt | type of test | Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. P... |
idK161258_s0_e2000 | K161258.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. ... |
idK161258_s0_e2000 | K161258.txt | product code | MOB, Aneutrophil cytoplasmic antibodies (ANCA) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. ... |
idK161258_s0_e2000 | K161258.txt | panel | Immunology (82) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F.... |
idK161258_s0_e2000 | K161258.txt | predicate device name | NOVA Lite ANCA | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Propr... |
idK161258_s0_e2000 | K161258.txt | applicant | Inova Diagnostics, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. ... |
idK161258_s0_e2000 | K161258.txt | regulation section | 21 CFR §866.5660, Multiple autoantibodies immunological test system | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. P... |
idK161258_s14000_e16000 | K161258.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK161258_s14000_e16000 | K161258.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
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