# K983694: Anticardiolipin Igm 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: 1 (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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Mar 27, 2003 · Not classified · Z-0950-03: Risk of false positives.

## Indications for use
The in-vitro measurement of IgM anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS).

Source page: https://510kreport.com/device/K983694
Methodology: https://510kreport.com/methodology