# K120817: Quanta Flash Acl Lga, Quanta Flash B2GP1 Iga

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Feb 26, 2013 after 344 days
- Product code: MID (System, Test, Anticardiolipin Immunological)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K243979: Aptiva APS IgA Reagent (2026), 0 descendants of its own

## Indications for use
QUANTA Flash aCL IgA: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgA antibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings. The QUANTA Flash aCL IgA Controls are intended for quality contro! purposes of the QUANTA Flash aCL IgA assay performed on the BIO-FLASH® instrument. Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 glycoprotein-1 (32GP1) IgA anlibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome, when used in conjunction with other laboratory and clinical findings. The QUANTA Flash $2GP1 IgA Controls are intended for the quality confrol purposes of the QUANTA Flash B2GP1 IgA assay performed on the BIO-FLASH® instrument.

Source page: https://510kreport.com/device/K120817
Methodology: https://510kreport.com/methodology