510(k) Report

510(k) · Cleared

Cleared

IG_Plex Celiac DGP Panel

K140691510(k) TraditionalCleared Nov 6, 2014232-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, Inc. · MVM Autoantibodies, Endomysial (Tissue Transglutaminase)

Cleared on Nov 6, 2014 as substantially equivalent to K052143 (Inova Diagnostics, Inc., 2005) and 4 other predicates after a 232-day review. Its family tree reaches back 2 generations to 2005.

Decided
Nov 6, 2014
Review
232 days
Class
Class II
Product code
MVM
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K042644 (2005). 6 ancestors in all, the oldest K011566 (2001). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 2 other ancestors2001: 2 other ancestorsK042644 · Aeskulisa TTG a and Aeskulisa TTG G · Aesku, Inc. · 2005 · recalledK102490 · Igx Plex Celiac Qualitative Assay · Sqi Diagnostics Systems · 20112000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors K102490 · Igx Plex Celiac Qualitative Assay · Sqi Diagnostics Systems · 2011K042644 · Aeskulisa TTG a and Aeskulisa TTG G · Aesku, Inc. · 2005 · recalled0
  1. Root · 2 generations backK042644 Aeskulisa TTG a and Aeskulisa TTG GAesku, Inc. · 2005 · Recalled
  2. 1 generation backK102490 Igx Plex Celiac Qualitative AssaySqi Diagnostics Systems · 2011
  3. This deviceK140691 IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K042644Aeskulisa TTG a and Aeskulisa TTG GAesku, Inc.20051
−1K102490Igx Plex Celiac Qualitative AssaySqi Diagnostics Systems2011—
0 (this device)K140691IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200520
FIG. 1 — Lineage of K140691, 2005–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K200230 Aptiva Celiac Disease IgG Reagentscore 2.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K052143Quanta Lite Gliadin Iga II
Summary page 5
…mentation for Clinical Multiplex Test Systems Substantial Equivalence: Inova Diagnostics, Inc. assays:  Quanta Lite™ Gliadin IgA II (k052143)  Quanta Lite™ Gliadin IgG II (k052142)  Quanta Lite™ h-tTG IgA…
Inova Diagnostics, Inc.2005—
*K052142Quanta Lite Gliadin Igg II
Summary page 5
…Inova Diagnostics, Inc. assays:  Quanta Lite™ Gliadin IgA II (k052143)  Quanta Lite™ Gliadin IgG II (k052142)  Quanta Lite™ h-tTG IgA ELISA (k011566)  Quanta Lite™ h-tTG Ig…
Inova Diagnostics, Inc.2005—
*K011566Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa
Summary page 5
…ta Lite™ Gliadin IgA II (k052143)  Quanta Lite™ Gliadin IgG II (k052142)  Quanta Lite™ h-tTG IgA ELISA (k011566)  Quanta Lite™ h-tTG IgG ELISA (k011570)  SQI Diagnostics SQiDw…
Inova Diagnostics, Inc.2001—
*K011570Quanta Lite H-TTG (Human Tissue Transglutaminase) Igg Elisa
Summary page 5
…a Lite™ Gliadin IgG II (k052142)  Quanta Lite™ h-tTG IgA ELISA (k011566)  Quanta Lite™ h-tTG IgG ELISA (k011570)  SQI Diagnostics SQiDworks™ Diagnostics Platform (k102490) SQI Diagnostics Inc., 36 Meteor…
Inova Diagnostics, Inc.2001—
*K102490Igx Plex Celiac Qualitative Assay
Summary page 5
…ISA (k011566)  Quanta Lite™ h-tTG IgG ELISA (k011570)  SQI Diagnostics SQiDworks™ Diagnostics Platform (k102490) SQI Diagnostics Inc., 36 Meteor Dr. Toronto ON M9W 1A4 tel. (416) 674-9500, fax (416) 674-9300…
Sqi Diagnostics Systems2011—

Also cleared against K052143: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K052143.

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. 2014, this device’s year, is highlighted.

FDA decisions per year · MVM

2in 2021

2007: 22008: 32010: 22011: 32013: 22014: 12019: 22021: 2
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MVM

275in 2011

2008: 98 days median2011: 275 days median
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

2017: 12024: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
200839800
20090—00
20102—00
2011327500
20120—00
20132—00
20141—00
20150—00
20160—00
20170—01
20180—00
20192—00
20200—00
20212—00
20220—00
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K052143

3 other devices cite the same predicate.

  • K130053Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga and Igg Calibrator…Bio-Rad Laboratories, Inc. · 2013
  • K113863Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta Flash DGP Igg CalibratorsInova Diagnostics, Inc. · 2012
  • K093459Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01, 14-5539-01Phadia US, Inc. · 20102 recalls

Recent decisions in MVM

The MVM category page

  • K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc. · 2021
  • K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc. · 2021
  • K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG ImmunoassayPhadia AB · 2019
  • K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)Euroimmun Us, Inc. · 2019
  • K123713Immulisa Enhanced Celiac Fusion (TTG/DGP) Iga/Igg Antibody ElisaImmco Diagnostics, Inc. · 2013

https://510kreport.com/device/K140691 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140691: IG_Plex Celiac DGP Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140691

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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