Cleared Traditional

K091522 - IMMULISA CELIAC G+ (GLIADIN) IGA AND IG...

K091522 is an FDA 510(k) clearance for IMMULISA CELIAC G+ (GLIADIN) IGA AND IG..., manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 258-day FDA review.

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

FDA 510(k) Submission Details - K091522

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
Combination Product No
PCCP Authorized No
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.

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 26
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
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
K093459 · Phadia US, Inc. · Aug 2010
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
K083053 · Euroimmun Us, Inc. · Aug 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
K083052 · Euroimmun Us, Inc. · Jul 2009
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT
K081674 · The Binding Site, Ltd. · Oct 2008