Cleared Traditional

K061794 - FIDIS TM THYRO, MODEL MX002

K061794 is an FDA 510(k) clearance for FIDIS TM THYRO, manufactured by Biomedical Diagnostics (Bmd) SA. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K061794 · Biomedical Diagnostics (Bmd) SA · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
148d
Days
Class 2
Risk

K061794 is an FDA 510(k) clearance for the FIDIS TM THYRO, MODEL MX002. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Biomedical Diagnostics (Bmd) SA (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on November 21, 2006 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - 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 Biomedical Diagnostics (Bmd) SA devices

FDA 510(k) Submission Details - K061794

510(k) Number K061794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2006
Decision Date November 21, 2006
Days to Decision 148 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 105d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZO Device Classification - Class 2, Special Controls

Product Code JZO System, Test, Thyroid Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
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 - JZO System, Test, Thyroid Autoantibody

All 68
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K061794.
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
K090760 · Theratest Laboratories, Inc. · Sep 2009
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K083391 · Diagnostic Hybrids, Inc. · May 2009
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092 · Roche Diagnostics Corp. · Jul 2008
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
K052407 · Fisher Diagnostics · Jul 2006
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
K061382 · Beckman Coulter, Inc. · Jul 2006
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
K052308 · Fisher Diagnostics · May 2006