Cleared Traditional

K931600 - CHEMILUMINESCENCE FREE T3 IMMUNOASSAY

K931600 is an FDA 510(k) clearance for CHEMILUMINESCENCE FREE T3 IMMUNOASSAY, manufactured by Nichols Institute. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K931600

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.

CDP Device Classification - Class 2, Special Controls

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 119
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
TRIODOTHYRONINE (TC) COATED TUBE RIA
K926345 · Monobind · Feb 1993
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT
K925436 · Medix Biotech, Inc. · Dec 1992
VISTA TRIIODOTHYRONINE ASSAY
K923571 · Syva Co. · Oct 1992