Cleared Traditional

K020208 - GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)

K020208 is an FDA 510(k) clearance for GLUCOMETER ELITE DIABETES CARE SYSTEM (..., manufactured by Bayer Group Diagnostics. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K020208 · Bayer Group Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
97d
Days
Class 2
Risk

K020208 is an FDA 510(k) clearance for the GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED). Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bayer Group Diagnostics (Elkhart, US). The FDA issued a Cleared decision on April 29, 2002 after a review of 97 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K020208

510(k) Number K020208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2002
Decision Date April 29, 2002
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 88d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
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 - NBW System, Test, Blood Glucose, Over The Counter

All 405
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K020208.
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
K020866 · Abbott Diabetes Care, Inc. · Jun 2002
ACCU-CHEK ADVANTAGE MODULE
K021513 · Roche Diagnostics Corp. · Jun 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021448 · Roche Diagnostics Corp. · Jun 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975 · Abbott Laboratories · Feb 2002
BIOSCANNER PLUS
K014099 · Polymer Technology Systems, Inc. · Dec 2001
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
K012014 · Abbott Diabetes Care, Inc. · Dec 2001