Cleared Traditional

K897144 - THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT

K897144 is the FDA 510(k) clearance for THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT by Medix Biotech, Inc.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K897144 · Medix Biotech, Inc. · Chemistry device
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Mar 1990
Decision
78d
Days
Class 2
Risk

K897144 is an FDA 510(k) clearance for the THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on March 15, 1990 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 K897144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date March 15, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 57
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K897144.
IL THYROXINE (T4) ASSAY SYSTEM
K903095 · Instrumentation Laboratory CO · Aug 1990
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990
OPUS T4 TEST SYSTEM
K897193 · Pb Diagnostic Systems, Inc. · Mar 1990
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K890831 · Syva Co. · Apr 1989
THYROXINE MICROASSAY
K884260 · Diamedix Corp. · Feb 1989
EMIT THYROXINE ASSAY
K885141 · Syva Co. · Feb 1989