# K040450: Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996

- 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.
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) INOVA QUANTA Lite B2 GPI IgA Antibodies: named in the summary without a submission number

## Most influential descendants
- K112414: Elia  B2-Glycoprotein I Iga Immunoassay (2012), 1 descendant of its own
- K181329: EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (2018), 0 descendants of its own

## Indications for use
The Varelisa 132-Glycoprotein I IgA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of [32 -glycoprotein I IgA antibodies in serum or plasma. The presence of [32 -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/K040450
Methodology: https://510kreport.com/methodology