Cleared Traditional

K153561 - AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System

K153561 is an FDA 510(k) clearance for AG-607 Blood Glucose Monitoring System ..., manufactured by Andon Health Co, Ltd.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 430-day FDA review.

K153561 · Andon Health Co, Ltd. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
430d
Days
Class 2
Risk

K153561 is an FDA 510(k) clearance for the AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitor.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on February 16, 2017 after a review of 430 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 Health Co, Ltd. devices

FDA 510(k) Submission Details - K153561

510(k) Number K153561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2015
Decision Date February 16, 2017
Days to Decision 430 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
342d slower than avg
Panel avg: 88d · This submission: 430d
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 510
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K153561.
POGO Automatic Blood Glucose Monitoring System
K162203 · Intuity Medical, Inc. · Apr 2017
Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System
K152534 · Tianjin Empecs Medical Device Co., Ltd. · Mar 2017
BGM009 Plus Blood Glucose Monitoring System
K170267 · Apex BioTechnology Corp. · Mar 2017
UniStrip1 Generic Blood Glucose Test Strips
K162430 · Ok Biotech Co., Ltd. · Jan 2017
Contour Next EZ Blood Glucose Monitoring System
K162336 · Ascensia Diabetes Care U.S., Inc. · Jan 2017
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
K161299 · Apex BioTechnology Corp. · Dec 2016