Cleared Traditional

K932607 - COBAS(R) CORE FT4 EIA

K932607 is an FDA 510(k) clearance for COBAS CORE FT4 EIA, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K932607 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jan 1994
Decision
241d
Days
Class 2
Risk

K932607 is an FDA 510(k) clearance for the COBAS(R) CORE FT4 EIA. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), 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 862.1695 - 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 - K932607

510(k) Number K932607 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.

CEC Device Classification - Class 2, Special Controls

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 77
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K932607.
OPUS FT4 TEST SYSTEM
K940507 · Pb Diagnostic Systems, Inc. · Jul 1994
AXSYM FREE THYROXINE ( FREE T4 )
K934544 · Abbott Laboratories · Jun 1994
CIBA CORNING ACS FT3 IMMUNOASSAY
K940482 · Ciba Corning Diagnostics Corp. · Apr 1994
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
K930322 · Heraeus Kulzer, Inc. · Nov 1993
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
K932912 · Baxter Diagnostics, Inc. · Oct 1993
IMMULITE FREE T4
K931704 · Diagnostic Products Corp. · Aug 1993