# K132082: Aeskulisa DGP-a, Aeskulisa DGP-G,Aeskulisa DGP-Check

- Pathway: 510(k) (Traditional)
- Applicant: Aesku Diagnostics
- Decided: Dec 5, 2013 after 153 days
- Product code: MST (Antibodies, Gliadin)
- Device class: 2
- Regulation: 21 CFR 866.5750
- 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 DGP-Check is an in-vitro diagnostic device. This solid phase enzyme immunoassay employs synthetic, deamidated gliadin-derived peptides for the combined semiquantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings. AESKULISA DGP-G is an in-vitro diagnostic device. This solid phase enzyme immunoassay employs synthetic, deamidated gliadin-derived peptides for the semiquantitative and qualitative detection of IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings. AESKULISA DGP-A is an in-vitro diagnostic device. This solid phase enzyme immunoassay employs synthetic, deamidated gliadin-derived peptides for the semiquantitative and qualitative detection of IgA antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

Source page: https://510kreport.com/device/K132082
Methodology: https://510kreport.com/methodology