Cleared Traditional

K140691 - IG_PLEX CELIAC DGP PANEL (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140691 · Sqi Diagnostics Systems, Inc. · Immunology device
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Nov 2014
Decision
232d
Days
Class 2
Risk

K140691 is an FDA 510(k) clearance for the IG_PLEX CELIAC DGP PANEL. Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Sqi Diagnostics Systems, Inc. (Toronto, On, CA). The FDA issued a Cleared decision on November 6, 2014 after a review of 232 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sqi Diagnostics Systems, Inc. devices

Submission Details

510(k) Number K140691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2014
Decision Date November 06, 2014
Days to Decision 232 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 104d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MVM Autoantibodies, Endomysial(tissue Transglutaminase)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - MVM Autoantibodies, Endomysial(tissue Transglutaminase)

All 39
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K140691.
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K183313 · Euroimmun Us, Inc. · Feb 2019