Cleared Traditional

T3 UPTAKE CHEMILUMINESCENCE ASSAY (K926220) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K926220 · Nichols Institute Diagnostics · Chemistry device
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Nov 1993
Decision
342d
Days
Class 2
Risk

K926220 is an FDA 510(k) clearance for the T3 UPTAKE CHEMILUMINESCENCE ASSAY. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on November 17, 1993 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1715 - 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. Elevated predicate reliance profile. 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 Diagnostics devices

Submission Details

510(k) Number K926220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1992
Decision Date November 17, 1993
Days to Decision 342 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
254d slower than avg
Panel avg: 88d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 - KHQ Radioassay, Triiodothyronine Uptake

All 92
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K926220.
ELECSYS T-UPTAKE ASSAY
K961488 · Boehringer Mannheim Corp. · Jun 1996
CEDIA T UPTAKE ASSAY
K954807 · Boehringer Mannheim Corp. · Dec 1995
AXSYM(TM) T-UPTAKE
K934312 · Abbott Laboratories · Jun 1994
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS
K926443 · Roche Diagnostic Systems, Inc. · May 1993
VISTA THYROXINE UPTAKE ASSAY
K923676 · Syva Co. · Oct 1992
IL T UPTAKE ASSAY SYSTEM
K903396 · Instrumentation Laboratory CO · Oct 1990