# K020156: Diastat Total Anti-Cardiolipin, Model Fcar 100T

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Mar 6, 2002 after 48 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.
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.

## Indications for use
The test is for the semi-quantitative combined detection of IgG, IgM and IgA autoantibodies specific for the Phospholipid Cardiolipin in huma serum or plasma (EDTA, citrate, heparin) The kit is intended to assess total anti-Cardiolipin autoantibody fevels in patients where this information is useful in diagnosis, particularly as an aid in the assessment of thrombotic risk in patients with systemic lupus erythematosus or other lupus-like disorders. Total anti-Cardiolipin levels represent one parameter in a multi—criterion diagnostic process.

Source page: https://510kreport.com/device/K020156
Methodology: https://510kreport.com/methodology