# K023433: Varelisa Cardiolipin Antibodies Screen, Models 15848 and 15896

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia Diagnostics GmbH & Co. KG
- Decided: Nov 13, 2002 after 29 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. The FDA summary names its predicate without a number.
- (no number) Varelisa Cardiolipin Antibodies Screen: named in the summary without a submission number

## Indications for use
The Varelisa Cardiolipin Antibodies Screen EIA kit is designed for the qualitative determination of cardiolipin antibodies in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).

Source page: https://510kreport.com/device/K023433
Methodology: https://510kreport.com/methodology