# K102490: Igx Plex Celiac Qualitative Assay

- Pathway: 510(k) (Traditional)
- Applicant: Sqi Diagnostics Systems
- Decided: Jun 2, 2011 after 275 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: 1 generation back to K042644 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042644: Aeskulisa TTG a and Aeskulisa TTG G, Aesku, Inc. (2005) Summary page 1.

## Most influential descendants
- K140691: IG_Plex Celiac DGP Panel (2014), 0 descendants of its own

## Indications for use
The lgX pLEXTM Celiac Qualitative Assay is an in vitro diagnostic test for the qualitative detection of the IgA and lgG immunoglobulin classes of anti-tissue transglutaminase antibody in 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 SQiDworksTM Diagnostics Platform.

Source page: https://510kreport.com/device/K102490
Methodology: https://510kreport.com/methodology