Cleared Traditional

COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS (K926443) - FDA 510(k) Clearance

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

K926443 · Roche Diagnostic Systems, Inc. · Chemistry device
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May 1993
Decision
148d
Days
Class 2
Risk

K926443 is an FDA 510(k) clearance for the COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on May 20, 1993 after a review of 148 days - within the typical 510(k) review window.

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. 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K926443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date May 20, 1993
Days to Decision 148 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 88d · This submission: 148d
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 K926443.
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K934312 · Abbott Laboratories · Jun 1994
VISTA THYROXINE UPTAKE ASSAY
K923676 · Syva Co. · Oct 1992
IL T UPTAKE ASSAY SYSTEM
K903396 · Instrumentation Laboratory CO · Oct 1990
EMIT T-UPTAKE ASSAY
K894145 · Syva Co. · Sep 1989