# K243979: Aptiva APS IgA Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Feb 6, 2026 after 410 days
- Product code: MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi))
- 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
Longest line of descent: 1 generation back to K120817 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120817: Quanta Flash Acl Lga, Quanta Flash B2GP1 Iga, Inova Diagnostics, Inc. (2013) Summary page 7.

## Indications for use
The Aptiva APS IgA Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GPI) IgA autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings. The Aptiva APS IgA Reagent is intended for use with the Aptiva System.

Source page: https://510kreport.com/device/K243979
Methodology: https://510kreport.com/methodology