# K131821: Elia (TM) Cardiolipin Iga Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Dec 23, 2013 after 186 days
- Product code: MID (System, Test, Anticardiolipin Immunological)
- 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 K953366 (1995). 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)
- K953366: Quanta Lite Iga Aca (HRP), Inova Diagnostics, Inc. (1995) 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 Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin 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 Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 100. EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiiolipin 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 Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 250. EliA APS Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and β2-Glycoprotein I with Phadia 100 using the EliA IgG, IgM or IgA method. EliA APS Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and β2-Glycoprotein I with Phadia 250 using the EliA IgG, IgM or IgA method. EliA IgG/IgM/IgA Negative Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of autoantibodies with Phadia 100 using the EliA IgG or IgM or IgA method. EliA IgG/IgM/IgA Negative Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of autoantibodies with Phadia 250 using the EliA IgG or IgM or IgA method.

Source page: https://510kreport.com/device/K131821
Methodology: https://510kreport.com/methodology