Cleared Traditional

K840901 - PHASE II FREE T4 KIT

K840901 is the FDA 510(k) clearance for PHASE II FREE T4 KIT by Medical & Scientific Designs, Inc.. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K840901 · Medical & Scientific Designs, Inc. · Chemistry device
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Apr 1984
Decision
57d
Days
Class 2
Risk

K840901 is an FDA 510(k) clearance for the PHASE II FREE T4 KIT. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Medical & Scientific Designs, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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 Medical & Scientific Designs, Inc. devices

Submission Details

510(k) Number K840901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1984
Decision Date April 25, 1984
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 65
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K840901.
AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA
K860251 · Amersham Corp. · Feb 1986
SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY
K853628 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985
AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT
K842482 · Amersham Corp. · Aug 1984
CORNING MAGIC SINGLE STEP FREE T4
K832381 · Corning Medical & Scientific · Sep 1983
THYROXINE ANALYSIS PRODUCTS/RADIO-FREE
K823264 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1983
SINGLE STEP FREE-T4 125I RADIOIMMUNO-
K823144 · Corning Medical & Scientific · Nov 1982