Cleared Traditional

K984137 - QUANTA LITE CELIAC SCREEN (TISSUE TRANS...

K984137 is the FDA 510(k) clearance for QUANTA LITE CELIAC SCREEN (TISSUE TRANS... by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code MVM) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K984137 · Inova Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
71d
Days
Class 2
Risk

K984137 is an FDA 510(k) clearance for the QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) 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 January 28, 1999 after a review of 71 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 K984137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1998
Decision Date January 28, 1999
Days to Decision 71 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
33d faster than avg
Panel avg: 104d · This submission: 71d
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 K984137.
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
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS
K981209 · The Binding Site, Ltd. · Oct 1998
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA
K982366 · Inova Diagnostics, Inc. · Aug 1998