Cleared Special

K031388 - MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM

K031388 is an FDA 510(k) clearance for MODIFICATION TO HYPOGUARD ADVANCE BLOOD..., manufactured by Hypoguard USA, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 20-day FDA review.

K031388 · Hypoguard USA, Inc. · Chemistry device
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May 2003
Decision
20d
Days
Class 2
Risk

K031388 is an FDA 510(k) clearance for the MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Hypoguard USA, Inc. (Edina, US). The FDA issued a Cleared decision on May 22, 2003 after a review of 20 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.

View all Hypoguard USA, Inc. devices

FDA 510(k) Submission Details - K031388

510(k) Number K031388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2003
Decision Date May 22, 2003
Days to Decision 20 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
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 286
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K031388.
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ASCENSIA BREEZE BLOOD GLUCOSE METER
K024062 · Bayer Corp. · Mar 2003
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
K023194 · Lifescan, Inc. · Oct 2002
BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
K022580 · Becton, Dickinson & CO · Oct 2002