# K983695: Anticardiolipin Iggam Screen Eia Diagnostic Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Feb 5, 1999 after 107 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 in-vitro qualitative screening of Iga, Igé and IgM autoantibodies against cardiolipin present in human serum. It may be used in conjunction with other serological assays and clinical information to aid in the diagnosis of antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE).

Source page: https://510kreport.com/device/K983695
Methodology: https://510kreport.com/methodology