510(k) Report

510(k) · Cleared

Cleared

Ifa Kit for the Detection of Endomysial Iga Anibodies Using Primate Umbilical Cord (Puc)-Ema/Puc Lga.

K002107510(k) TraditionalCleared Aug 4, 200023-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

Scimedx Corp. · MVM Autoantibodies, Endomysial (Tissue Transglutaminase)

Cleared on Aug 4, 2000 after a 23-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Aug 4, 2000
Review
23 days
Class
Class II
Product code
MVM
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K002107Source: FDA 510(k) database · 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), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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.

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

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—

More from Scimedx Corp.

14 FDA decisions under this applicant name. See the company

  • K011348Phase II GBM Igg Antibody Eia TestScimedx Corp. · 2001
  • K011082Tpo Igg Antibody Eia TestScimedx Corp. · 2001
  • K010625Eurospital EU-TTG Iga UmanaScimedx Corp. · 2001
  • K010287Scimedx Phase II PR3 Igg Antibody EiaScimedx Corp. · 2001
  • K010289Scimedx Phase II Mpo Igg Antibody EiaScimedx Corp. · 2001

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
  • K140691IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc. · 2014

https://510kreport.com/device/K002107 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002107: Ifa Kit for the Detection of Endomysial Iga Anibodies Using Primate Umbilical Cord (Puc)-Ema/Puc Lga..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002107

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026