Cleared Traditional

K023256 - PRECISION XTRA/MEDISENSE OPTIUM/PRECISI...

K023256 is an FDA 510(k) clearance for PRECISION XTRA/MEDISENSE OPTIUM/PRECISI..., manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 205-day FDA review.

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

FDA 510(k) Submission Details - K023256

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.

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 266
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K023256.
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005
K031260 · Abbott Diabetes Care, Inc. · Dec 2003
ACCU-CHEK ADVANTAGE SYSTEM
K032552 · Roche Diagnostics Corp. · Sep 2003
MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K031843 · Medline Industries, Inc. · Jul 2003
ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
K024194 · Lifescan, Inc. · Feb 2003
ASCENSIA GLUCOFACTS
K024234 · Bayer Corp. · Jan 2003
SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K023832 · Lifescan, Inc. · Dec 2002