Cleared Traditional

K063818 - QUANTA PLEX CELIAC IGA PROFILE

K063818 is the FDA 510(k) clearance for QUANTA PLEX CELIAC IGA PROFILE by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code MVM) cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K063818 · Inova Diagnostics, Inc. · Immunology device
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Jun 2007
Decision
180d
Days
Class 2
Risk

K063818 is an FDA 510(k) clearance for the QUANTA PLEX CELIAC IGA 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 June 20, 2007 after a review of 180 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

Submission Details

510(k) Number K063818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date June 20, 2007
Days to Decision 180 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
76d slower than avg
Panel avg: 104d · This submission: 180d
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 K063818.
QUANTA LITE H-TTG SCREEN
K073145 · Inova Diagnostics, Inc. · Feb 2008
QUANTA PLEX CELIAC IGG PROFILE
K072632 · Inova Diagnostics, Inc. · Feb 2008
QUANTA LITE F-ACTIN IGA ELISA
K072967 · Inova Diagnostics, Inc. · Jan 2008
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
K060157 · Immco Diagnostics, Inc. · May 2006
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
K040095 · Immco Diagnostics, Inc. · Mar 2004
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
K032571 · Immco Diagnostics, Inc. · Dec 2003