# K223093: Aptiva APS IgG Reagent; Aptiva APS IgM Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Dec 17, 2024 after 809 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
Longest line of descent: 2 generations back to K022992 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092181: Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm Controls, Instrumentation Laboratory CO (2010) Summary page 7.
- K970551: Quanta Lite B2GPI Igg, Inova Diagnostics, Inc. (1997) Summary page 7.
- K091556: Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls, Instrumentation Laboratory CO (2010) Summary page 7.

## Indications for use
The Aptiva APS IgG 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) IgG autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings. The Aptiva APS IgG Reagent is intended for use with the Aptiva System. The Aptiva APS IgM 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) IgM autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings. The Aptiva APS IgM Reagent is intended for use with the Aptiva System.

Source page: https://510kreport.com/device/K223093
Methodology: https://510kreport.com/methodology