Cleared Traditional

K052143 - QUANTA LITE GLIADIN IGA II

K052143 is the FDA 510(k) clearance for QUANTA LITE GLIADIN IGA II by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code MST) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K052143 · Inova Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
57d
Days
Class 2
Risk

K052143 is an FDA 510(k) clearance for the QUANTA LITE GLIADIN IGA 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.

View all Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K052143 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
47d faster than avg
Panel avg: 104d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K052143.
QUANTA LITE H-TTG/DGP SCREEN
K070083 · Inova Diagnostics, Inc. · Mar 2007
QUANTA LITE CELIAC DGP SCREEN
K062708 · Inova Diagnostics, Inc. · Dec 2006
QUANTA LITE GLIADIN IGG II
K052142 · Inova Diagnostics, Inc. · Oct 2005
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · Diamedix Corp. · Sep 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · Diamedix Corp. · Sep 2001
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
K001393 · Zeus Scientific, Inc. · Jun 2000