# K040452: Varelisa B2 Glycoprotein I Antibodies Screen, Models 19048 and 19096

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia Deutschland GmbH
- Decided: May 11, 2004 after 81 days
- Product code: MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi))
- 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) INOVA QUANTA Lite  β2 GPI Screen: named in the summary without a submission number

## Indications for use
The Varelisa β2-Glycoprotein I Antibodies Screen EIA kit is designed for the qualitative determination of β2-Glycoprotein I antibodies in human serum or plasma. The presence of β2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.

Source page: https://510kreport.com/device/K040452
Methodology: https://510kreport.com/methodology