# K021398: Apl Iga Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Louisville Apl Diagnostics, Inc.
- Decided: Aug 27, 2002 after 117 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 Antiphospholipid Syndrome is a clinical diagnosis supported by finding a positive antiphospholipid ELISA and/or lupus anticoagulant test. Indications for the test include: patients with unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained occlusion of the arterial circulation resulting in stroke, myocardial infarction, or peripheral gangrene. In patients with unexplained venous thrombosis, other disorder should be excluded, such as protein C, S, or antithrombin I11 deficiency, as well as malignancy or the nephrotic syndrome. The test is also indicated in women with one or more unexplained second or third trimester pregnancy losses or two or more first trimester losses. Finally, patients with unexplained thrombocytopenia as well as other abnormalities said to be associated with the Antiphospholipid Syndrome should be tested. The APL@IgA ELISA Kit is a semiquantitative enzyme linked immunosorben assay (ELISA) for use as an aid in diagnosing the Antiphospholipid Syndrome (A P S) in patients presenting with thrombosis, pregnancy losses and/or thrombocytopenia. It enables measurement of IgA anticardiolpin antibody levels in human serum.

Source page: https://510kreport.com/device/K021398
Methodology: https://510kreport.com/methodology