# K162788: ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Jun 19, 2017 after 259 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
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. The FDA summary names its predicate without a number.
- (no number) INOVA QUANTA Lite™ β2 GPI IgA, IgG, IgM and Screen ELISAs: named in the summary without a submission number

## Indications for use
Enzyme-linked immunosorbent assay (ELISA) for the qualitative or semi-quantitative detection of p2-GPI IgA antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme-linked immunosorbent assay (ELISA) for the qualitative or semi-quantitative detection of p2-GPI 1gG antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme-linked immunosorbent assay (ELISA) for the qualitative or semi-quantitative detection of f2-GPI IgM antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of B2-GPI IgA, IgG and IgM antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.

Source page: https://510kreport.com/device/K162788
Methodology: https://510kreport.com/methodology