# K062217: Aeskulska BETA2-Glyco-a

- Pathway: 510(k) (Traditional)
- Applicant: Aesku, Inc.
- Decided: Dec 13, 2006 after 134 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 no predicate by number.

## Indications for use
AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. The presence of anti-β2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome. AESKULISA β2 Glyco-GM is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the separate semiquantitative and qualitative detection of IgG and/or IgM antibodies against β2 glycoprotein I in human serum. The presence of anti-β2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome. AESKULISA β2 Glyco-Check is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the combined semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against β2 glycoprotein I in human serum. The presence of anti-β2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

Source page: https://510kreport.com/device/K062217
Methodology: https://510kreport.com/methodology