Cleared Traditional

FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM (K130094) - FDA 510(k) Clearance

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

K130094 · Abbott Diabetes Care · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
168d
Days
Class 2
Risk

K130094 is an FDA 510(k) clearance for the FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Abbott Diabetes Care (Alameda, US). The FDA issued a Cleared decision on June 27, 2013 after a review of 168 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 devices

Submission Details

510(k) Number K130094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2013
Decision Date June 27, 2013
Days to Decision 168 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
80d slower than avg
Panel avg: 88d · This submission: 168d
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 K130094.
FORA GD43 Blood Glucose Monitoring System
K143467 · Taidoc Technology Corporation · May 2015
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K141867 · Roche Diagnostics · Mar 2015
ACCU-CHEK Performa Blood Glucose Monitoring System
K133741 · Roche Diagnostics · Aug 2014
FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
K124040 · Taidoc Technology Corporation · May 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
K123089 · Abbott Laboratories · Apr 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · Roche Diagnostics Corp. · Mar 2013