Cleared Traditional

K101307 - BLOOD GLUCOSE MONITORING SYSTEM

K101307 is the FDA 510(k) clearance for BLOOD GLUCOSE MONITORING SYSTEM by Andon Medical Co., Ltd.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 456-day FDA review.

K101307 · Andon Medical Co., Ltd. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 2011
Decision
456d
Days
Class 2
Risk

K101307 is an FDA 510(k) clearance for the BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Andon Medical Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on August 9, 2011 after a review of 456 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Andon Medical Co., Ltd. devices

Submission Details

510(k) Number K101307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2010
Decision Date August 09, 2011
Days to Decision 456 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
368d slower than avg
Panel avg: 88d · This submission: 456d
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 K101307.
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