Cleared Traditional

COBAS (R) CORE T4 EIA (K932605) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 85
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K932605.
ABBOTT ARCHITECT TOTAL T4
K983440 · Abbott Laboratories · Nov 1998
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321 · Bio-Rad · Aug 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
K946163 · Bio-Rad · Feb 1995
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433 · Syva Co. · Sep 1992
CEDIA T4
K915194 · Boehringer Mannheim Corp. · Dec 1991
IL THYROXINE (T4) ASSAY SYSTEM
K903095 · Instrumentation Laboratory CO · Aug 1990