Cleared Traditional

K072632 - QUANTA PLEX CELIAC IGG PROFILE

K072632 is the FDA 510(k) clearance for QUANTA PLEX CELIAC IGG PROFILE by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code MVM) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K072632 · Inova Diagnostics, Inc. · Immunology device
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Feb 2008
Decision
146d
Days
Class 2
Risk

K072632 is an FDA 510(k) clearance for the QUANTA PLEX CELIAC IGG PROFILE. 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 February 11, 2008 after a review of 146 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K072632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2007
Decision Date February 11, 2008
Days to Decision 146 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
42d slower than avg
Panel avg: 104d · This submission: 146d
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 22
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K072632.
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
QUANTA LITE F-ACTIN IGA ELISA
K072967 · Inova Diagnostics, Inc. · Jan 2008
QUANTA PLEX CELIAC IGA PROFILE
K063818 · Inova Diagnostics, Inc. · Jun 2007
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
K060157 · Immco Diagnostics, Inc. · May 2006