Cleared Special

K020935 - HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706

K020935 is an FDA 510(k) clearance for HEMOCUE GLUCOSE 201 SYSTEM, manufactured by Hemocue, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 12-day FDA review.

K020935 · Hemocue, Inc. · Chemistry device
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Apr 2002
Decision
12d
Days
Class 2
Risk

K020935 is an FDA 510(k) clearance for the HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Hemocue, Inc. (Potomac, US). The FDA issued a Cleared decision on April 3, 2002 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 - K020935

510(k) Number K020935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2002
Decision Date April 03, 2002
Days to Decision 12 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 89d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

CGA Device Classification - Class 2, Special Controls

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 400
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K020935.
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K020935 · HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
Download PDF Hemocue, Inc.