Cleared Traditional

K072274 - MAJOR III BLOOD GLUCOSE MONITORING SYSTEM

K072274 is the FDA 510(k) clearance for MAJOR III BLOOD GLUCOSE MONITORING SYSTEM by Bestgen Biotech Corp.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K072274 · Bestgen Biotech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
198d
Days
Class 2
Risk

K072274 is an FDA 510(k) clearance for the MAJOR III BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bestgen Biotech Corp. (Hsin Chu City, TW). The FDA issued a Cleared decision on February 29, 2008 after a review of 198 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 Bestgen Biotech Corp. devices

Submission Details

510(k) Number K072274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2007
Decision Date February 29, 2008
Days to Decision 198 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
110d slower than avg
Panel avg: 88d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 236
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K072274.
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GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
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PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM
K072784 · Taidoc Technology Corporation · Dec 2007
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225
K071493 · Taidoc Technology Corporation · Oct 2007
ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
K072543 · Lifescan, Inc. · Oct 2007