Cleared Traditional

K041354 - VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896

K041354 is an FDA 510(k) clearance for VARELISA GLIADIN IGA ANTIBODIES MODEL #..., manufactured by Sweden Diagnostics (Germany) GmbH. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K041354 · Sweden Diagnostics (Germany) GmbH · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
57d
Days
Class 2
Risk

K041354 is an FDA 510(k) clearance for the VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Sweden Diagnostics (Germany) GmbH (Freiburg, DE). The FDA issued a Cleared decision on July 16, 2004 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.

FDA 510(k) Submission Details - K041354

510(k) Number K041354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2004
Decision Date July 16, 2004
Days to Decision 57 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
48d faster than avg
Panel avg: 105d · This submission: 57d
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 K041354.
QUANTA LITE GLIADIN IGA II
K052143 · Inova Diagnostics, Inc. · Oct 2005
FIDIS CELIAC
K041002 · Biomedical Diagnostics S.A. · Sep 2004
VARELISA GLIADIN IGG ANTIBODIES
K041357 · Sweden Diagnostics (Germany) GmbH · Aug 2004
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · Diamedix Corp. · Sep 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · Diamedix Corp. · Sep 2001
GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
K002169 · Scimedx Corp. · Oct 2000
K041354 · VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
Download PDF FDA Summary Sweden Diagnostics (G…