# K200230: Aptiva Celiac Disease IgG Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Aug 26, 2021 after 574 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: 2 generations back to K052143 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113863: Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta Flash DGP Igg Calibrators, Inova Diagnostics, Inc. (2012) Summary page 6.
- K101644: Quanta Flash H-TTG Igg, Inova Diagnostics, Inc. (2011) Summary page 6.

## Indications for use
The Aptiva Celiac Disease IgG Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semi-quantitative determination of anti-tissue transglutaminase IgG autoantibodies and anti-deamidated gliadin peptide IgG autoantibodies in human serum. The presence of these antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of celiac disease and dermatitis herpetiformis, particularly in patients with selective IgA deficiency. The Aptiva Celiac Disease IgG Reagent is intended for use with the Inova Diagnostics Aptiva System.

Source page: https://510kreport.com/device/K200230
Methodology: https://510kreport.com/methodology