Cleared Traditional

K052142 - QUANTA LITE GLIADIN IGG II

K052142 is an FDA 510(k) clearance for QUANTA LITE GLIADIN IGG II, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K052142 · Inova Diagnostics, Inc. · Immunology device
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Oct 2005
Decision
57d
Days
Class 2
Risk

K052142 is an FDA 510(k) clearance for the QUANTA LITE GLIADIN IGG II. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 4, 2005 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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.

FDA 510(k) Submission Details - K052142

510(k) Number K052142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2005
Decision Date October 04, 2005
Days to Decision 57 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
48d faster than avg
Panel avg: 105d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MST Device Classification - Class 2, Special Controls

Product Code MST Antibodies, Gliadin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 - MST Antibodies, Gliadin

All 41
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K052142.
FIDIS CELIAC
K053383 · Biomedical Diagnostics (Bmd) SA · Mar 2006
AESKULISA GLIA A AND AESKULISA GLIA G
K052439 · Aesku Diagnostics · Feb 2006
IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02
K052793 · Pharmacia Diagnostics AB · Feb 2006
QUANTA LITE GLIADIN IGA II
K052143 · Inova Diagnostics, Inc. · Oct 2005
FIDIS CELIAC
K041002 · Biomedical Diagnostics S.A. · Sep 2004
VARELISA GLIADIN IGG ANTIBODIES
K041357 · Sweden Diagnostics (Germany) GmbH · Aug 2004
K052142 · QUANTA LITE GLIADIN IGG II
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