# K971039: Hemagen Anti Cardiolipin Screen

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Jun 3, 1997 after 74 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: 1 generation back to K932373 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932373: Hemagen Cardiolipin Antibody Kit (Eia METHOD0, Hemagen Diagnostics, Inc. (1993) Summary page 1.
- K941840: Hemagen Acl Iga Calibrator, Hemagen Diagnostics, Inc. (1994) Summary page 1.

## Indications for use
The anti Cardiolipin Screen is indicated for the screening of patient serum for the presence of igG, IgM, and IgA autoantibodies to cardiolipin. Autoantibodies to aCl are typically observed in patients with systemic lupus erythematosus and other connective tissue diseases. This assay is intended to be utilized as an aid in the diagnosis of antiphospholipid syndrome.

Source page: https://510kreport.com/device/K971039
Methodology: https://510kreport.com/methodology