# K091845: Cardiolipin Autoantibody Immunological Test System

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Jun 7, 2010 after 350 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 K020752 (2002). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020752: Varelisa Cardiolipin Igg Antibodies, Models 15548 & 15596, Pharmacia Deutschland GmbH (2002) Summary page 2.
- K020758: Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696, Pharmacia Deutschland GmbH (2002) Summary page 2.
- K040449: Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796, Pharmacia Deutschland GmbH (2004) Summary page 2.
- K040451: Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848 and 18896, Pharmacia Deutschland GmbH (2004) Summary page 2.

## Most influential descendants
- 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
EliA Cardiolipin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgG uses the EliA IgG method on the instrument Phadia 100. EliA Cardiolipin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgG uses the EliA IgG method on the instrument Phadia 250. EliA Cardiolipin IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgM uses the EliA IgM method on the instrument Phadia 100. EliA Cardiolipin IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgM uses the EliA IgM method on the instrument Phadia 250. EliA β2-Glycoprotein I IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to β2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA β2-Glycoprotein I IgG uses the EliA IgG method on the instrument Phadia 100. EliA β2-Glycoprotein I IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to β2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA β2-Glycoprotein I IgG uses the EliA IgG method on the instrument Phadia 250. EliA β2-Glycoprotein I IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to β2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA β2-Glycoprotein I IgM uses the EliA IgM method on the instrument Phadia 100. EliA β2-Glycoprotein I IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to β2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA β2-Glycoprotein I IgM uses the EliA IgM method on the instrument 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 or IgM 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 or IgM method.

Source page: https://510kreport.com/device/K091845
Methodology: https://510kreport.com/methodology