Cleared Special

K060108 - COBAS INTEGRA CHLORIDE ELCTRODE GEN.2

K060108 is an FDA 510(k) clearance for COBAS INTEGRA CHLORIDE ELCTRODE GEN.2, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code CGZ cleared through the Special 510(k) pathway after a 34-day FDA review.

K060108 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
34d
Days
Class 2
Risk

K060108 is an FDA 510(k) clearance for the COBAS INTEGRA CHLORIDE ELCTRODE GEN.2. Classified as Electrode, Ion-specific, Chloride (product code CGZ), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 16, 2006 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K060108

510(k) Number K060108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2006
Decision Date February 16, 2006
Days to Decision 34 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

CGZ Device Classification - Class 2, Special Controls

Product Code CGZ Electrode, Ion-specific, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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 - CGZ Electrode, Ion-specific, Chloride

All 35
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K060108 · COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
Download PDF FDA Summary Roche Diagnostics Cor…