# K043433: Autostat II Anti-Tissue Transglutaminase Igg Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Hycor Biomedical, Ltd.
- Decided: Mar 7, 2005 after 84 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
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
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum. Uses: The results of the anti-tTg assay can be used as an aid in the diagnosis of Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. In addition to the manual assay protocol, this device has been validated for use with the HYCOR HY.TEC automated EIA instrument. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K043433
Methodology: https://510kreport.com/methodology