Cleared Traditional

K931600 - CHEMILUMINESCENCE FREE T3 IMMUNOASSAY

K931600 is the FDA 510(k) clearance for CHEMILUMINESCENCE FREE T3 IMMUNOASSAY by Nichols Institute. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K931600 · Nichols Institute · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
160d
Days
Class 2
Risk

K931600 is an FDA 510(k) clearance for the CHEMILUMINESCENCE FREE T3 IMMUNOASSAY. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Nichols Institute (San Juan Capistrano, US). The FDA issued a Cleared decision on September 8, 1993 after a review of 160 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Nichols Institute devices

Submission Details

510(k) Number K931600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1993
Decision Date September 08, 1993
Days to Decision 160 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 88d · This submission: 160d
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 92
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K931600.
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
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT
K925436 · Medix Biotech, Inc. · Dec 1992
VISTA TRIIODOTHYRONINE ASSAY
K923571 · Syva Co. · Oct 1992
KODAK AMERLEX MAB FT3 ASSAY
K922771 · Eastman Kodak Company · Oct 1992