Cleared Traditional

K925436 - MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASS...

K925436 is the FDA 510(k) clearance for MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASS... by Medix Biotech, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K925436 · Medix Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
61d
Days
Class 2
Risk

K925436 is an FDA 510(k) clearance for the MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - the FDA in vitro diagnostics and chemistry 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.

View all Medix Biotech, Inc. devices

Submission Details

510(k) Number K925436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1992
Decision Date December 28, 1992
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 88d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 Chemistry devices follow this clearance model.

Regulatory Peers - CDP Radioimmunoassay, Total Triiodothyronine

All 93
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K925436.
VIDAS T3 ASSAY
K934764 · Biomerieux Vitek, Inc. · Mar 1994
COBAS(R) CORE T3 EIA
K932608 · Roche Diagnostic Systems, Inc. · Dec 1993
CIBA CORNING ACS FREE T3 IMMUNOASSAY
K932747 · Ciba Corning Diagnostics Corp. · Dec 1993
VISTA TRIIODOTHYRONINE ASSAY
K923571 · Syva Co. · Oct 1992
KODAK AMERLEX MAB FT3 ASSAY
K922771 · Eastman Kodak Company · Oct 1992
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
K923258 · Heraeus Kulzer, Inc. · Sep 1992