Cleared Traditional

K932605 - COBAS (R) CORE T4 EIA

K932605 is an FDA 510(k) clearance for COBAS CORE T4 EIA, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K932605 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jan 1994
Decision
241d
Days
Class 2
Risk

K932605 is an FDA 510(k) clearance for the COBAS (R) CORE T4 EIA. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 24, 1994 after a review of 241 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 - K932605

510(k) Number K932605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1993
Decision Date January 24, 1994
Days to Decision 241 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
153d slower than avg
Panel avg: 88d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLI Device Classification - Class 2, Special Controls

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 70
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K932605.
CEDIA T4 MAB ASSAY
K942575 · Microgenics Corp. · Jul 1994
CEDIA T4 MAB ASSAY
K941042 · Microgenics Corp. · Apr 1994
CEDIA T4 MAB ASSAY MODIFICATION
K935880 · Microgenics Corp. · Mar 1994
ACCESS(R) THYROXINE ASSAY
K926475 · Bio-Rad Laboratories, Inc. · Jun 1993
VIDAS THYROXINE (T4) ASSAY (T4)
K926393 · Biomerieux Vitek, Inc. · May 1993
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433 · Syva Co. · Sep 1992