Cleared Traditional

K002621 - GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM

K002621 is the FDA 510(k) clearance for GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM by Apex BioTechnology Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K002621 · Apex BioTechnology Corp. · Chemistry device
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Jan 2001
Decision
152d
Days
Class 2
Risk

K002621 is an FDA 510(k) clearance for the GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Apex BioTechnology Corp. (Plymouth, US). The FDA issued a Cleared decision on January 22, 2001 after a review of 152 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 Apex BioTechnology Corp. devices

Submission Details

510(k) Number K002621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2000
Decision Date January 22, 2001
Days to Decision 152 days
Submission Type Traditional
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
64d slower than avg
Panel avg: 88d · This submission: 152d
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 190
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K002621.
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
K011233 · Apex BioTechnology Corp. · May 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
K010520 · Instrumentation Laboratory CO · May 2001
RANDOX GLUCOSE (GOD/PAP)
K003346 · Randox Laboratories, Ltd. · Mar 2001
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
K002624 · Apex BioTechnology Corp. · Jan 2001
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
K001441 · Lifescan, Inc. · Dec 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907 · Roche Diagnostics Corp. · Sep 2000