# K011570: Quanta Lite H-TTG (Human Tissue Transglutaminase) Igg Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jul 9, 2001 after 49 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K140691: IG_Plex Celiac DGP Panel (2014), 0 descendants of its own
- K130053: Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga and Igg Calibrator Sets, and BI (2013), 0 descendants of its own
- K073145: Quanta Lite H-TTG Screen (2008), 0 descendants of its own

## Indications for use
An Enzyme Linked Immunosorbant Assay (ELISA) for the semi-quantitative detection of IgG antibodies to tissue transglutamlnase (endomysium) in human serum. Detection of these antibodies, in conjunction with IgA antibodies, is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis. This test is intended for providing added sensitivity when testing IgA deficient patients.

Source page: https://510kreport.com/device/K011570
Methodology: https://510kreport.com/methodology