510(k) · Cleared
ClearedQuanta Flash PR3, Quanta Flash Mpo, Quanta Flash GBM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Cleared on Jul 31, 2012 after a 334-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 31, 2012
- Review
- 334 days
- Class
- Class II
- Product code
- MOB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOB device
- #1 K261466 Alegria Flash MPO; Alegria Flash PR3; Alegria…score 11.9 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MOB devicesMOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MOB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOB
221in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOB
1in 2012
MAUDE reports naming product code MOB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 379 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 221 | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (405 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K112545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112545: Quanta Flash PR3, Quanta Flash Mpo, Quanta Flash GBM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112545
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026