Cleared Traditional

K140691 - IG_PLEX CELIAC DGP PANEL

K140691 is an FDA 510(k) clearance for IG_PLEX CELIAC DGP PANEL, manufactured by Sqi Diagnostics Systems, Inc.. The device is a Class 2 Immunology device with product code MVM cleared through the Traditional 510(k) pathway after a 232-day FDA review.

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

FDA 510(k) Submission Details - K140691

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.

MVM Device Classification - Class 2, Special Controls

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 26
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K140691.
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