| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software |
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| Generic Name | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS |
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| Applicant | DiaSorin, Inc.
1951 Northwestern Avenue
Stillwater, MN 55082-0285 |
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| PMA Number | P180047 |
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| Date Received | 12/10/2018 |
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| Decision Date | 11/26/2019 |
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| Product Code |
NCD |
| Docket Number | 19M-5683 |
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| Notice Date | 12/03/2019 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the LIAISON QuantiFERON-TB Gold Plus assay, the LIAISON Control QuantiERON-TB Gold Plus, and the LIAISON QuantiFERON Software.The LIAISON QuantiFERON-TB Gold Plus assay is an in vitro diagnostic test intended for the detection of interferon-y (IFN-y) in human lithium heparin plasma by chemiluminescence immunoassay (CLIA) using the LIAISON XL Analyzer. QIAGEN QuantiFERON-TB Gold Plus Blood Collection Tubes, containing a peptide cocktail simulating ESAT-6, and CFP-10 proteins, are used in conjunction with the LIAISON QuantiFERON-TB Gold Plus assay to stimulate cells in heparinized whole blood. Detection of IFN-y is used to identify in vitro responses to these peptide antigens that are associated with Mycobacterium tuberculosis infection.The assay is a qualitative indirect test for M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations to assist the clinician in making individual patient management decisions. The LIAISON QuantiFERON-TB Gold Plus assay must be performed using the LIAISON XL Analyzer.The LIAISON Control QuantiFERON-TB Gold Plus is intended for use as assayed quality control samples to monitor the performance of the LIAISON QuantiFERON-TB Gold Plus assay. The performance characteristics of LIAISON Control QuantiFERON-TB Gold Plus have not been established for any other assays or instrument platforms other than the LIAISON XL Analyzer.The LIAISON QuantiFERON Software (LQS) is optional software intended to analyze the data generated by the LIAISON QuantiFERON-TB Gold Plus assay on the LIAISON XL Analyzer. LQS reports assay results as positive, negative, or indeterminate by an algorithm that combines the individual results associated with the four QIAGEN QuantiFERON-TB Gold Plus Blood Collection Tubes into a final result. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024
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