# K140691: IG_Plex Celiac DGP Panel

- Pathway: 510(k) (Traditional)
- Applicant: Sqi Diagnostics Systems, Inc.
- Decided: Nov 6, 2014 after 232 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 K042644 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 5.
- K052142: Quanta Lite Gliadin Igg II, Inova Diagnostics, Inc. (2005) Summary page 5.
- K011566: Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa, Inova Diagnostics, Inc. (2001) Summary page 5.
- K011570: Quanta Lite H-TTG (Human Tissue Transglutaminase) Igg Elisa, Inova Diagnostics, Inc. (2001) Summary page 5.
- K102490: Igx Plex Celiac Qualitative Assay, Sqi Diagnostics Systems (2011) Summary page 5.

## Indications for use
The Ig_plex Celiac DGP Panel is an in vitro diagnostic test for the semi-quantitative detection of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (tTG) in human serum. The test is intended for use in clinical laboratories as an aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings, and requires the sqid-X system.

Source page: https://510kreport.com/device/K140691
Methodology: https://510kreport.com/methodology