Cleared Traditional

K926443 - COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS

K926443 is an FDA 510(k) clearance for COBAS-FP REAGENTS FOR T-UPTAKE/CALIBRATORS, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code KHQ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

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

FDA 510(k) Submission Details - K926443

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.

KHQ Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K926443.
AXSYM(TM) T-UPTAKE
K934312 · Abbott Laboratories · Jun 1994
VIDAS T UPTAKE
K935816 · Biomerieux Vitek, Inc. · Mar 1994
T3 UPTAKE CHEMILUMINESCENCE ASSAY
K926220 · Nichols Institute Diagnostics · Nov 1993
CIBA CORNING ACS T UPTAKE IMMUNOASSAY
K925257 · Ciba Corning Diagnostics Corp. · Dec 1992
VISTA THYROXINE UPTAKE ASSAY
K923676 · Syva Co. · Oct 1992
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)
K911912 · Serono-Baker Diagnostics, Inc. · Sep 1991