LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Premarket Approval P180047

Pre-market Approval Supplement Details

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-? (ifn-? ) 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-? 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.

DeviceLIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software
Classification NameTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis
Generic NameTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis
ApplicantDiaSorin, Inc.
Date Received2018-12-10
Decision Date2019-11-26
PMAP180047
SupplementS
Product CodeNCD
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address DiaSorin, Inc. 1951 Northwestern Avenue stillwater, MN 55082-0285

Supplemental Filings

Supplement NumberDateSupplement Type
P180047Original Filing

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