Cleared Traditional

K012795 - DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM

K012795 is an FDA 510(k) clearance for DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM, manufactured by Diamedix Corp.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K012795 · Diamedix Corp. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
38d
Days
Class 2
Risk

K012795 is an FDA 510(k) clearance for the DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 38 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 - K012795

510(k) Number K012795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2001
Decision Date September 28, 2001
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 105d · This submission: 38d
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 K012795.
FIDIS CELIAC
K041002 · Biomedical Diagnostics S.A. · Sep 2004
VARELISA GLIADIN IGG ANTIBODIES
K041357 · Sweden Diagnostics (Germany) GmbH · Aug 2004
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
K041354 · Sweden Diagnostics (Germany) GmbH · Jul 2004
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · Diamedix Corp. · Sep 2001
GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
K002169 · Scimedx Corp. · Oct 2000
GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
K002189 · Scimedx Corp. · Oct 2000
K012795 · DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
Download PDF FDA Summary Diamedix Corp.