Cleared Traditional

K041174 - CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196

K041174 is an FDA 510(k) clearance for CELIKEY TTG (HUMAN, manufactured by Sweden Diagnostics (Germany) GmbH. The device is a Class 2 Immunology device with product code MVM cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K041174 · 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
75d
Days
Class 2
Risk

K041174 is an FDA 510(k) clearance for the CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196. Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Sweden Diagnostics (Germany) GmbH (Freiburg, DE). The FDA issued a Cleared decision on July 19, 2004 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 - K041174

510(k) Number K041174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2004
Decision Date July 19, 2004
Days to Decision 75 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
30d faster than avg
Panel avg: 105d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVM Device Classification - Class 2, Special Controls

Product Code MVM Autoantibodies, Endomysial(tissue Transglutaminase)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MVM Autoantibodies, Endomysial(tissue Transglutaminase)

All 39
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K041174.
AESKULISA TTG A AND AESKULISA TTG G
K042644 · Aesku, Inc. · Jun 2005
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA
K043433 · Hycor Biomedical , Ltd. · Mar 2005
CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
K041173 · Sweden Diagnostics (Germany) GmbH · Aug 2004
BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS
K040466 · The Binding Site · Jul 2004
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
K040095 · Immco Diagnostics, Inc. · Mar 2004
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
K033744 · Hycor Biomedical , Ltd. · Jan 2004
K041174 · CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
Download PDF FDA Summary Sweden Diagnostics (G…