# K073145: Quanta Lite H-TTG Screen

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Feb 12, 2008 after 96 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 K011566 (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)
- K011566: Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa, Inova Diagnostics, Inc. (2001) Summary page 2.
- K011570: Quanta Lite H-TTG (Human Tissue Transglutaminase) Igg Elisa, Inova Diagnostics, Inc. (2001) Summary page 2.

## Indications for use
The QUANTA Lite T H h-tTG Screen is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgA and IgG antibodies to human tissue transglutaminase (h-tTG) in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of both IgA sufficient and IgA deficient celiac disease as well as dermatitis herpetiformis.

Source page: https://510kreport.com/device/K073145
Methodology: https://510kreport.com/methodology