Cleared Traditional

K926441 - ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI

K926441 is an FDA 510(k) clearance for ROCHE COBAS-FP REAGENT FOR TOTAL T4 THY..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code KLT cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K926441 · Roche Diagnostic Systems, Inc. · Chemistry device
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May 1993
Decision
154d
Days
Class 2
Risk

K926441 is an FDA 510(k) clearance for the ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 154 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3645 - 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 - K926441

510(k) Number K926441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date May 26, 1993
Days to Decision 154 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
66d slower than avg
Panel avg: 88d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLT Device Classification - Class 2, Special Controls

Product Code KLT Enzyme Immunoassay, Carbamazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
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 - KLT Enzyme Immunoassay, Carbamazepine

All 50
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K926441.
AXSYM CARBAMAZEPHINE
K935374 · Abbott Laboratories · Jun 1994
QMS CARBAMAZEPINE ASSAY
K940374 · Seradyn, Inc. · Jun 1994
IL TEST CARBAMAZEPHINE
K933684 · Instrumentation Laboratory CO · Oct 1993
CEDIA(R) CARBAMAZEPINE ASSAY
K914857 · Microgenics Corp. · Jan 1992
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
K913066 · Syva Co. · Jul 1991
ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
K901086 · Boehringer Mannheim Corp. · Mar 1990