510(k) · Cleared

Recalled · Class II · 2019

Aeskulisa TTG a and Aeskulisa TTG G

K042644510(k) TraditionalCleared Jun 1, 2005247-day reviewClass II21 CFR 866.5660Recalls 1

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

Aesku, Inc. · MVM Autoantibodies, Endomysial (Tissue Transglutaminase)

Cleared on Jun 1, 2005 after a 247-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled once.

Decided: Jun 1, 2005
Review: 247 days
Class: Class II
Product code: MVM
Recalls: 1
Predicates: 0

3 later devices descend from it, 2 citing it directly.

This deviceK042644 Aeskulisa TTG a and Aeskulisa TTG GAesku, Inc. · 2005
Descendant · cites it directly · 1 of its ownK102490 Igx Plex Celiac Qualitative AssaySqi Diagnostics Systems · 2011
Descendant · 2 generations on · 0 of its ownK140691 IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc. · 2014
Descendant · cites it directly · 0 of its ownK102964 EU-TTG Iga and EU-TTG IggGrifols USA, Inc. · 2011

Most influential descendants

Showing 3 of 3 · See all

K102490Igx Plex Celiac Qualitative AssaySqi Diagnostics Systems · 2011 · cites it directly1descendant
K140691IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc. · 2014 · 2 generations on0descendants
K102964EU-TTG Iga and EU-TTG IggGrifols USA, Inc. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K042644	Aeskulisa TTG a and Aeskulisa TTG G	Aesku, Inc.	2005	—
+1	K102490	Igx Plex Celiac Qualitative Assay	Sqi Diagnostics Systems	2011	—
+2	K140691	IG_Plex Celiac DGP Panel	Sqi Diagnostics Systems, Inc.	2014	—
+1	K102964	EU-TTG Iga and EU-TTG Igg	Grifols USA, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2014	1	0

FIG. 1 — Lineage of K042644, 2005–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102490	Igx Plex Celiac Qualitative Assay	Sqi Diagnostics Systems	2011	1
K102964	EU-TTG Iga and EU-TTG Igg	Grifols USA, Inc.	2011	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 3, 2019	Class II	Z-1800-2020	Under Investigation by firm	An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K102490 (Sqi Diagnostics Systems, 2011) has gone furthest, with 1 descendant of its own.

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.

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?

AESKULISA tTg A is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig A antibodies against tissue transglutaminase (tTG) in human serum.

The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

AESKULISA tTg G is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig G antibodies against tissue transglutaminase (tTG) in human serum.

The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K042644 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042644: Aeskulisa TTG a and Aeskulisa TTG G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042644

Report an extraction error

Are you the manufacturer?

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