# K181329: EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Jun 25, 2018 after 38 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: 2 generations back to K040450 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112414: Elia  B2-Glycoprotein I Iga Immunoassay, Phadia US, Inc. (2012) Summary page 6.
- K131821: Elia (TM) Cardiolipin Iga Immunoassay, Phadia US, Inc. (2013) Summary page 6.

## Indications for use
EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA) 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 ß2-Glycoprotein I IgA uses the EliA IgA method on the instrument Phadia 2500/5000. EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA) 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 Cardiolipin IgA uses the EliA IgA method on the instrument Phadia 2500/5000.

Source page: https://510kreport.com/device/K181329
Methodology: https://510kreport.com/methodology