Cleared Traditional

PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO (K023256) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023256 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
205d
Days
Class 2
Risk

K023256 is an FDA 510(k) clearance for the PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GL.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Abbott Laboratories (Bedford, US). The FDA issued a Cleared decision on April 23, 2003 after a review of 205 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 Abbott Laboratories devices

Submission Details

510(k) Number K023256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date April 23, 2003
Days to Decision 205 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
117d slower than avg
Panel avg: 88d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 165
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K023256.
PRECISION XCEED DIABETES MONITORING SYSTEM
K033845 · Abbott Laboratories · Jan 2004
ACCU-CHEK ADVANTAGE SYSTEM
K032552 · Roche Diagnostics Corp. · Sep 2003
MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K031843 · Medline Industries, Inc. · Jul 2003
BECTON DICKINSON DIABETES SOFTWARE
K023219 · Becton, Dickinson & CO · Dec 2002
BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
K022581 · Becton, Dickinson & CO · Oct 2002
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM
K022182 · Abbott Laboratories · Sep 2002