# K102964: EU-TTG Iga  and EU-TTG Igg

- Pathway: 510(k) (Traditional)
- Applicant: Grifols USA, Inc.
- Decided: Mar 7, 2011 after 153 days
- Product code: MVM (Autoantibodies, Endomysial(Tissue Transglutaminase))
- 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
Longest line of descent: 1 generation back to K010625 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010625: Eurospital EU-TTG Iga Umana, Scimedx Corp. (2001) Summary page 1.
- K042644: Aeskulisa TTG a and Aeskulisa TTG G, Aesku, Inc. (2005) Summary page 1.

## Indications for use
The Eu-tTG® IgA is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgA specific antibodies directed against tissue transglutamninase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings. The Eu-tTG® IgG is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgG specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

Source page: https://510kreport.com/device/K102964
Methodology: https://510kreport.com/methodology