Cleared Traditional

K101307 - BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951

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

K101307 · Andon Medical Co., Ltd. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K101307

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
367d slower than avg
Panel avg: 89d · This submission: 456d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00976924 Completed Interventional Industry-sponsored

Clinical Test of Blood Glucose Test Strips

200
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes
Study design Parallel
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Sponsor Andon Medical Co.,Ltd (industry)
Started 2009-07-01 → Primary completion 2009-07-01
Primary outcome
blood glucose value
Study completed - no results published. This trial concluded in 2009 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K101307.
TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM
K101635 · Taidoc Technology Corporation · Aug 2011
TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
K101543 · Tyson Bioresearch, Inc. · Aug 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
K102678 · Andon Medical Co., Ltd. · Aug 2011
TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
K110571 · Telcare, Inc. · Jul 2011
AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM
K093755 · Andon Medical Co., Ltd. · Jul 2011
FORA POCT MANAGMENT SYSTEM
K111029 · Taidoc Technology Corporation · Jul 2011
K101307 · BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
Download PDF FDA Summary Andon Medical Co., Lt…