Cleared Traditional

K093745 - ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM

K093745 is an FDA 510(k) clearance for ONE TOUCH VERIO BLOOD GLUCOSE MONITORIN..., manufactured by Lifescan, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 434-day FDA review.

K093745 · Lifescan, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
434d
Days
Class 2
Risk

K093745 is an FDA 510(k) clearance for the ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Lifescan, Inc. (Milpitas, US). The FDA issued a Cleared decision on February 11, 2011 after a review of 434 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 Lifescan, Inc. devices

FDA 510(k) Submission Details - K093745

510(k) Number K093745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2009
Decision Date February 11, 2011
Days to Decision 434 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
346d slower than avg
Panel avg: 88d · This submission: 434d
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 309
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K093745.
CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
K102049 · Taidoc Technology Corporation · May 2011
HEALTH CARE SYSTEM SOFTWARE
K110948 · Taidoc Technology Corporation · May 2011
AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
K102481 · Apex BioTechnology Corp. · Apr 2011
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