Cleared Traditional

K011566 - QUANTA LITE H-TTG (HUMAN TISSUE TRANSGL...

K011566 is the FDA 510(k) clearance for QUANTA LITE H-TTG (HUMAN TISSUE TRANSGL... by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code MVM) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K011566 · Inova Diagnostics, Inc. · Immunology device
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Jul 2001
Decision
49d
Days
Class 2
Risk

K011566 is an FDA 510(k) clearance for the QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA. 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 July 9, 2001 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K011566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2001
Decision Date July 09, 2001
Days to Decision 49 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
55d faster than avg
Panel avg: 104d · This submission: 49d
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 K011566.
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
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
K011570 · Inova Diagnostics, Inc. · Jul 2001
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
K993612 · The Binding Site, Ltd. · Dec 1999
ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST
K992878 · Immco Diagnostics, Inc. · Oct 1999