# K020752: Varelisa Cardiolipin Igg Antibodies, Models 15548 & 15596

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia Deutschland GmbH
- Decided: May 2, 2002 after 56 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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 (IgG) Antibodies: named in the summary without a submission number

## Most influential descendants
- K091845: Cardiolipin Autoantibody Immunological Test System (2010), 1 descendant of its own
- K151799: EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 (2016), 0 descendants of its own

## Indications for use
The Varelisa Cardiolipin IgG Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgG antibodies against cardiolipin 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/K020752
Methodology: https://510kreport.com/methodology