# K033744: Autostat II Anti-Tisue Transglutaminase Iga Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Hycor Biomedical, Ltd.
- Decided: Jan 20, 2004 after 50 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Enzyme linked immunosorbent assay method for the semi-quantitative determination specific IgA 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 auto-immun, diseases associated with elevated levels of anti-tTg antibodies including Coeliac Diset Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime This device can be used with the HYCOR HY.TEC automated EIA instrument. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K033744
Methodology: https://510kreport.com/methodology