Cleared Traditional

K110017 - AG-608N BLOOD GLUCOSE MONITORING SYSTEM

K110017 is an FDA 510(k) clearance for AG-608N 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 380-day FDA review.

K110017 · Andon Medical Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
380d
Days
Class 2
Risk

K110017 is an FDA 510(k) clearance for the AG-608N BLOOD GLUCOSE MONITORING SYSTEM. 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 January 18, 2012 after a review of 380 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Andon Medical Co., Ltd. devices

FDA 510(k) Submission Details - K110017

510(k) Number K110017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2011
Decision Date January 18, 2012
Days to Decision 380 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
292d slower than avg
Panel avg: 88d · This submission: 380d
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
NCT01268345 Completed Interventional Industry-sponsored

AST Clinical Investigation

63
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes
Study design Parallel
Eligibility All sexes · 21 Years+ · Healthy volunteers accepted
Sponsor Andon Medical Co.,Ltd (industry)
Started 2010-10-01 → Primary completion 2010-12-01
Primary outcome
blood glucose value
Study completed - no results published. This trial concluded in 2010 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 420
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K110017.
MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
K111456 · Tianjin Empecs Medical Device Co., Ltd. · Feb 2012
DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
K113343 · Delbio Incorporation · Feb 2012
FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM
K111890 · Taidoc Technology Corporation · Feb 2012
AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
K113098 · Apex BioTechnology Corp. · Jan 2012
GLUCOSE TEST SYSTEM
K113137 · Roche Diagnostics · Jan 2012
FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K101926 · Taidoc Technology Corporation · Dec 2011