Cleared Traditional

IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA (K091522) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091522 · Immco Diagnostics, Inc. · Immunology device
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Feb 2010
Decision
258d
Days
Class 2
Risk

K091522 is an FDA 510(k) clearance for the IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on February 4, 2010 after a review of 258 days - an extended review 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: 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 Immco Diagnostics, Inc. devices

Submission Details

510(k) Number K091522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2009
Decision Date February 04, 2010
Days to Decision 258 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 104d · This submission: 258d
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 15
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K091522.
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
K113863 · Inova Diagnostics, Inc. · Sep 2012
QUANTA FLASH (TM) DGP SCREEN
K111414 · Inova Diagnostics, Inc. · Oct 2011
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT
K081674 · The Binding Site, Ltd. · Oct 2008
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