# K111414: Quanta Flash (TM) DGP Screen

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Oct 20, 2011 after 153 days
- Product code: MST (Antibodies, Gliadin)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The QUANTA Flash TM DGP Screen is a chemiluminescent immunoassay (CIA) for the semi-quantitative detection of IqG and IgA anti-dleamidlated gliadin peptidle (DGP) antibodies in human serum on the RIO-FLASHS instrument, it is an aid in the diagnosis of celiac disease and dermatitis herpetiformis in conjunction with clinical findings and other laboratory tests. The QUANTA Flash Tm DGP Screen Calibrators are intended for use with the QUANTA Flash " DGP Screen chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgG and igA anti-DGP antibodies in serum. The QUANTA FlashTm DGP Screen Controls are intended for quality control purposes of the QUANTA Flash Tm DOP Screen chemiluminescent immunoassay (CIA) kit run on a RIO-FLASH®, instrument.

Source page: https://510kreport.com/device/K111414
Methodology: https://510kreport.com/methodology