Cleared Traditional

K823144 - SINGLE STEP FREE-T4 125I RADIOIMMUNO-

K823144 is the FDA 510(k) clearance for SINGLE STEP FREE-T4 125I RADIOIMMUNO- by Corning Medical & Scientific. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K823144 · Corning Medical & Scientific · Chemistry device
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Nov 1982
Decision
35d
Days
Class 2
Risk

K823144 is an FDA 510(k) clearance for the SINGLE STEP FREE-T4 125I RADIOIMMUNO-. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on November 29, 1982 after a review of 35 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 Corning Medical & Scientific devices

Submission Details

510(k) Number K823144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1982
Decision Date November 29, 1982
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 63
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K823144.
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
COAT-A-COUNT FREE THYROXINE KIT/COMPONEN
K822882 · Diagnostic Products Corp. · Nov 1982
FREE T4 RIA TEST SET
K813465 · Ventrex Laboratories, Inc. · Dec 1981
CODE IM 2050 AMERLEX FREE T4 RIA KIT
K810231 · Amersham Corp. · Feb 1981