# K101644: Quanta Flash H-TTG Igg

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Mar 23, 2011 after 286 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K200230: Aptiva Celiac Disease IgG Reagent (2021), 0 descendants of its own

## Indications for use
The QUANTA Flash h-tTG IgG is a chemiluminescent immunoassay (CIA) for the semi-quantitative detection of IgG anti-human tissue transglutaminase (h-tTG) antibodies in human serum. The presence of IgG anti-h-tTG antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of the gluten sensitive enteropathy celiac disease, particularly in patients with selective IgA deficiency. The QUANTA Flash h-tTG IgG Calibrators are intended for use with the QUANTA Flash h-tTG IgG chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used to determine values in the measurement of IgG anti-h-tTG antibodies in serum. The QUANTA Flash h-tTG IgG Controls are intended for quality control purposes of the QUANTA Flash h-tTG IgG chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument.

Source page: https://510kreport.com/device/K101644
Methodology: https://510kreport.com/methodology