Cleared Traditional

K964341 - IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TES...

K964341 is an FDA 510(k) clearance for IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TES..., 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 211-day FDA review.

K964341 · Immco Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
211d
Days
Class 2
Risk

K964341 is an FDA 510(k) clearance for the IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT. 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 May 30, 1997 after a review of 211 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 - K964341

510(k) Number K964341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1996
Decision Date May 30, 1997
Days to Decision 211 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
107d slower than avg
Panel avg: 104d · This submission: 211d
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 K964341.
BINDAZYME ANTIGLIADIN IGG
K981644 · The Binding Site, Ltd. · Sep 1998
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
K981929 · The Binding Site, Ltd. · Sep 1998
QUANTA LITE IGA GLIADIN ELISA
K964986 · Inova Diagnostics, Inc. · Jun 1997
IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT
K964344 · Immco Diagnostics, Inc. · May 1997
QUANTA LITE IGG GLIADIN ELISA
K964985 · Inova Diagnostics, Inc. · May 1997