Cleared Traditional

K971653 - GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SY...

K971653 is the FDA 510(k) clearance for GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SY... by Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K971653 · Clinical Diagnostics, Inc. · Chemistry device
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Jan 1998
Decision
241d
Days
Class 2
Risk

K971653 is an FDA 510(k) clearance for the GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Clinical Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on January 2, 1998 after a review of 241 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K971653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1997
Decision Date January 02, 1998
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 CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 197
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