# K112414: Elia  B2-Glycoprotein I Iga Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Jun 22, 2012 after 305 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
Longest line of descent: 1 generation back to K040450 (2004). 1 ancestor in all.
1 later device descends 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)
- K040450: Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996, Pharmacia Deutschland GmbH (2004) Summary page 2.

## Most influential descendants
- K181329: EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (2018), 0 descendants of its own

## Indications for use
EliA B2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to B2-Glycoprotein I in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.

Source page: https://510kreport.com/device/K112414
Methodology: https://510kreport.com/methodology