# K040451: Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848 and 18896

- 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 IgM: 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 β2-Glycoprotein I IgM Antibodies EIA kit is designed for the semiquantitative and qualitative determination of β2-glycoprotein I IgM antibodies in 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/K040451
Methodology: https://510kreport.com/methodology