Cleared Traditional

K031260 - FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 507
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