# K001981: Diastat Anti-Cardiolipin Iga, Model Fcar 500

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield, Ltd.
- Decided: Aug 21, 2000 after 53 days
- Product code: MID (System, Test, Anticardiolipin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: 2 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Nov 1, 2004 · Not classified · Z-0927-05: DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).
- Jan 23, 2004 · Not classified · Z-0632-05: DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.

Source page: https://510kreport.com/device/K001981
Methodology: https://510kreport.com/methodology