Cleared Traditional

K951595 - ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES

K951595 is an FDA 510(k) clearance for ROCHE COBAS INTEGRA ANALYZER, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K951595 · Roche Diagnostic Systems, Inc. · Chemistry device
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Sep 1995
Decision
155d
Days
Class 2
Risk

K951595 is an FDA 510(k) clearance for the ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 155 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 - K951595

510(k) Number K951595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1995
Decision Date September 08, 1995
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 88d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGX Device Classification - Class 2, Special Controls

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 142
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K951595.
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K954266 · Solarcare Technologies Corp,Inc. · Oct 1995
CREATININE QVET
K943005 · Prisma Systems · Nov 1994
CREATININE-PO REAGENT KIT
K943924 · Synermed, Inc. · Sep 1994
ROCHE REAGENT FOR CREATININE
K941837 · Roche Diagnostic Systems, Inc. · Aug 1994