# K113863: Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta Flash DGP Igg Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Sep 20, 2012 after 265 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
Longest line of descent: 1 generation back to K052143 (2005). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052143: Quanta Lite Gliadin Iga II, Inova Diagnostics, Inc. (2005) Summary page 2.
- K052142: Quanta Lite Gliadin Igg II, Inova Diagnostics, Inc. (2005) Summary page 2.

## Most influential descendants
- K200230: Aptiva Celiac Disease IgG Reagent (2021), 0 descendants of its own
- K193604: Aptiva Celiac Disease IgA Reagent (2021), 0 descendants of its own

## Indications for use
The QUANTA Flash DGP IgA Controls are intended for quality control purposes of the QUANTA Flash DGP IgA chemiluminescent immunoassay (CIA) kit run on the BIO FLASH® Instrument that is used for the measurement of IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum. The QUANTA Flash DGP IgG Controls are intended for quality control purposes of the QUANTA Flash DGP IgG chemiluminescent immunoassay (CIA) kit run on the BIO FLASH ® Instrument that is used for the measurement of IgG anti-deamidated gliadin peptide (DGP) antibodies in human serum. The QUANTA Flash™ DGP IgA is a chemiluminescent immunoassay for the semi-quantitative determination of IgA antibodies to synthetic, deamidated gliadin peptides in human serum. The presence of IgA deamidated gliadin peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease and dermatitis herpetiformis. The QUANTA Flash™ DGP IgG is a chemiluminescent immunoassay for the semi-quantitative detection of IgG antibodies to synthetic, deamidated gliadin peptides in human serum. The presence of IgG deamidated gliadin peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease in both IgA sufficient and IgA deficient subjects, as well as dermatitis herpetiformis. The QUANTA Flash™ DGP IgA Calibrators are intended for use with the QUANTA Flash™ DGP IgA chemiluminescent immunoassay to establish paints of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgA anti-DGP antibodies in serum. The QUANTA Flash™ DGP IgG Calibrators are intended for use with the QUANTA Flash™ DGP IgG chemiluminescent immunoassay to establish points of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgG anti-DGP antibodies in serum.

Source page: https://510kreport.com/device/K113863
Methodology: https://510kreport.com/methodology