# K113020: Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) Elisas

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Oct 25, 2012 after 380 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
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgA antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgG antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgM antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative detection of Cardiolipin IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of anti-phospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.

Source page: https://510kreport.com/device/K113020
Methodology: https://510kreport.com/methodology