# K112545: Quanta Flash PR3, Quanta Flash Mpo, Quanta Flash GBM

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jul 31, 2012 after 334 days
- Product code: MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The QUANTA Flash PR3 is a chemiluminescent immunoassay (CIA) for the semi-quantitative 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 BJO-FLASll® instrument. Each calibrator establishes a point of reference for the workinig curve that is used in the measurement of IgG anti-proteinase 3 (PM) autoantibodies in human serum. The QUANTA Flash PR3 Controls are intended for quality control purposes of the QUANTA Flash PR3 chemiluminescent inmmoassay (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 semi-quantitative detection of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum on the BLO0-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 MPG Calibrators are intended for use with the QUANTA Flash MPG chemiluminescent inmmunoassay (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 (MPG) autoantibodies in human serum. The QUANTA Flash MPG Controls are intended for quality control purposes of the QUANTA Flash MPG chemiluminescent immnunoassay (CIA) kit run on a BIG0-FLASH® instrument that is used in the measurement of IgG anti-myeloperoxidase (MPG) autoantibodies in human serum. The QUANTA Flash GBM is a chemilumninescent immunoassay (CIA) for the semi-quantitative detection of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum on the 1110-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 immunassay (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 inmmoassay (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.

Source page: https://510kreport.com/device/K112545
Methodology: https://510kreport.com/methodology