Cleared Traditional

FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 (K031260) - FDA 510(k) Clearance

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

K031260 · Abbott Diabetes Care, Inc. · Chemistry device
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Dec 2003
Decision
242d
Days
Class 2
Risk

K031260 is an FDA 510(k) clearance for the FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEM.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 242 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 Diabetes Care, Inc. devices

Submission Details

510(k) Number K031260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2003
Decision Date December 19, 2003
Days to Decision 242 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
154d slower than avg
Panel avg: 88d · This submission: 242d
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 166
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K031260.
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814 · Abbott Laboratories · Apr 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628 · Abbott Laboratories · Mar 2004
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
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO
K023256 · Abbott Laboratories · Apr 2003