Cleared Traditional

K093262 - AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM

K093262 is an FDA 510(k) clearance for AG-608 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 267-day FDA review.

K093262 · Andon Medical Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
267d
Days
Class 2
Risk

K093262 is an FDA 510(k) clearance for the AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SY.... 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 July 13, 2010 after a review of 267 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 Andon Medical Co., Ltd. devices

FDA 510(k) Submission Details - K093262

510(k) Number K093262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2009
Decision Date July 13, 2010
Days to Decision 267 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
179d slower than avg
Panel avg: 88d · This submission: 267d
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 421
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K093262.
ON CALL PLUS DIABETES MONITORING SOFTWARE
K101371 · ACON Laboratories, Inc. · Jan 2011
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
K100937 · I-Sens, Inc. · Dec 2010
ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER
K092875 · Taidoc Technology Corporation · Aug 2010
FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
K100732 · Taidoc Technology Corporation · Jul 2010
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
K101457 · Eps Bio Technology Corp. · Jul 2010
TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
K100322 · Taidoc Technology Corporation · Jun 2010