# K984173: The Aptus (Automated) Application of the Anti-Cardiolipin Iga Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Dec 22, 1998 after 32 days
- Product code: MID (System, Test, Anticardiolipin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Jun 22, 2001 · Not classified · Z-1147-03: Bacterial contamination of the high positive control.

## Indications for use
Autoantibodies directed against phospholipids, and anti-cardiolipin (aCL) in particular, have been associated with recurrent thrombosis, thrombocytopenia, and spontaneous abortions. Detection of these autoantibodies may aid in the diagnosis of such disorders. The Zeus Scientific, Inc. anti-Cardiolipin IgA ELISA Test System is an automated or manually operated enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgA autoantibodies to cardiolipin. This test is for in vifro diagnostic use.

Source page: https://510kreport.com/device/K984173
Methodology: https://510kreport.com/methodology