510(k) · Cleared

Cleared

Igx Plex Celiac Qualitative Assay

K102490510(k) TraditionalCleared Jun 2, 2011275-day reviewClass II21 CFR 866.5660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sqi Diagnostics Systems · MVM Autoantibodies, Endomysial (Tissue Transglutaminase)

Cleared on Jun 2, 2011 as substantially equivalent to K042644 (Aesku, Inc., 2005) after a 275-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.

Decided: Jun 2, 2011
Review: 275 days
Class: Class II
Product code: MVM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K042644 (2005). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK042644 Aeskulisa TTG a and Aeskulisa TTG GAesku, Inc. · 2005 · Recalled
This deviceK102490 Igx Plex Celiac Qualitative AssaySqi Diagnostics Systems · 2011
Descendant · cites it directly · 0 of its ownK140691 IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all

K140691IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K042644	Aeskulisa TTG a and Aeskulisa TTG G	Aesku, Inc.	2005	1
0 (this device)	K102490	Igx Plex Celiac Qualitative Assay	Sqi Diagnostics Systems	2011	—
+1	K140691	IG_Plex Celiac DGP Panel	Sqi Diagnostics Systems, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K102490, 2005–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MVM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MVM device

#1 K200230 Aptiva Celiac Disease IgG Reagentscore 2.2 · 2 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K042644	Aeskulisa TTG a and Aeskulisa TTG G Summary page 1 …ass 11 Product Code: MVM-866.5660: Autoantibodies, Endomysial (Tissue Transglutaminase) Substantial Aesku, Inc.- Aeskulisa tTG A and tTG G (K(042644) Equivalence: SQU 36 Meteor Drive…	Aesku, Inc.	2005	1

Also cleared against K042644: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K140691	IG_Plex Celiac DGP Panel	Sqi Diagnostics Systems, Inc.	2014	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K140691 (Sqi Diagnostics Systems, Inc., 2014) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K042644.

How does its category compare?

All MVM devices

MVM Autoantibodies, Endomysial (Tissue Transglutaminase): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MVM

2in 2021

2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MVM

275in 2011

2007high 275 (2011) · low 98 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MVM

No recall names MVM since 2007.

Adverse event reports per year · MVM

1in 2024

2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code MVM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	0
2008	3	98	0
2009	0	—	0
2010	2	—	0
2011	3	275	0
2012	0	—	0
2013	2	—	0
2014	1	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	1
2018	0	—	0
2019	2	—	0
2020	0	—	0
2021	2	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	1
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102490 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102490: Igx Plex Celiac Qualitative Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102490

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026