Cleared Traditional

K101644 - QUANTA FLASH H-TTG IGG

K101644 is an FDA 510(k) clearance for QUANTA FLASH H-TTG IGG, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MVM cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K101644 · Inova Diagnostics, Inc. · Immunology device
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Mar 2011
Decision
286d
Days
Class 2
Risk

K101644 is an FDA 510(k) clearance for the QUANTA FLASH H-TTG IGG. Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on March 23, 2011 after a review of 286 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 Inova Diagnostics, Inc. devices

FDA 510(k) Submission Details - K101644

510(k) Number K101644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2010
Decision Date March 23, 2011
Days to Decision 286 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 105d · This submission: 286d
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 32
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K101644.
IG_PLEX CELIAC DGP PANEL
K140691 · Sqi Diagnostics Systems, Inc. · Nov 2014
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
K123713 · Immco Diagnostics, Inc. · Oct 2013
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
K130053 · Bio-Rad Laboratories, Inc. · Sep 2013
QUANTA FLASH H-TTG IGA
K094060 · Inova Diagnostics, Inc. · Oct 2010
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
K091520 · Immco Diagnostics, Inc. · Mar 2010
QUANTA LITE H-TTG SCREEN
K073145 · Inova Diagnostics, Inc. · Feb 2008