# K193604: Aptiva Celiac Disease IgA Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jun 16, 2021 after 541 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.
- K094060: Quanta Flash H-TTG Iga, Inova Diagnostics, Inc. (2010) Summary page 6.

## Indications for use
The Aptiva Celiac Disease IgA Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semi-quantitative determination of anti-tissue transglutaminase IgA autoantibodies and anti-deamidated gliadin peptide IgA autoantibodies in human serum. The presence of these autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of celiac disease and dermatitis herpetiformis. The Aptiva Celiac Disease [gA Reagent is intended for use with the Inova Diagnostics Aptiva System. Aptiva System is an automated particle-based multi-analyte analyzer for in vitro diagnostic testing of clinical specimens. The system is based on digital capture of high-resolution images of the paramagnetic particles to determine the analytes in samples.

Source page: https://510kreport.com/device/K193604
Methodology: https://510kreport.com/methodology