# K040463: Aeskulisa Cardiolipin Agm

- Pathway: 510(k) (Traditional)
- Applicant: Aesku, Inc.
- Decided: May 12, 2004 after 79 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
AESKULISA Cardiolipin-AGM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human 12-glycoprotein I for the semiquantitative and qualitative detection of IgA, IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and 12-glycoprotein I which are only expressed when R2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings. AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human 92-glycoprotein I for the semiquantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and 112-glycoprotein I which are only expressed when 92-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings. AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human 12-glycoprotein I for the semiquantitative and qualitative detection of IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and fo2-glycoprotein I which are only expressed when r92-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings. AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human 12-glycoprotein I for the combined semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and 12-glycoprotein I which are only expressed when 112-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

Source page: https://510kreport.com/device/K040463
Methodology: https://510kreport.com/methodology