(334 days)
The QUANTA Flash PR3 is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-proteinase 3 (PR3) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash PR3 is an aid in the diagnosis of granulomatosis with polyangiitis (GPA) in conjunction with clinical findings and other laboratory tests.
The QUANTA Flash PR3 Calibrators are intended for use with the QUANTA Flash PR3 chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-proteinase 3 (PR3) autoantibodies in human serum.
The QUANTA Flash PR3 Controls are intended for quality control purposes of the QUANTA Flash PR3 chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-proteinase 3 (PR3) autoantibodies in human serum.
The QUANTA Flash MPO is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash MPO is an aid in the diagnosis of microscopic polyangiitis (MPA) in conjunction with clinical findings and other laboratory tests.
The QUANTA Flash MPO Calibrators are intended for use with the QUANTA Flash MPO chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum.
The QUANTA Flash MPO Controls are intended for quality control purposes of the QUANTA Flash MPO chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum.
The QUANTA Flash GBM is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash GBM is an aid in the diagnosis of Goodpasture's Syndrome in conjunction with clinical findings and other laboratory tests.
The QUANTA Flash GBM Calibrators are intended for use with the QUANTA Flash GBM chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum.
The QUANTA Flash GBM Controls are intended for quality control purposes of the QUANTA Flash GBM chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum.
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This document is an FDA 510(k) clearance letter for the QUANTA Flash® suite of autoantibody detection assays. It primarily outlines the indications for use for each reagent, calibrator, and control, and states that the devices are substantially equivalent to legally marketed predicate devices.
The document does not contain the acceptance criteria or study details regarding the performance of the device. This type of information is typically found in the 510(k) submission summary or other supporting documentation, which is not provided in your input. The FDA clearance letter summarizes the regulatory decision, not the technical performance data that led to it.
Therefore, requested information cannot be extracted from the provided text.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).