Cleared Traditional

K123559 - SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM

K123559 is the FDA 510(k) clearance for SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM by Biotest Medical Corp.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K123559 · Biotest Medical Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jun 2013
Decision
221d
Days
Class 2
Risk

K123559 is an FDA 510(k) clearance for the SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Biotest Medical Corp. (Taichung, TW). The FDA issued a Cleared decision on June 28, 2013 after a review of 221 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 Biotest Medical Corp. devices

Submission Details

510(k) Number K123559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2012
Decision Date June 28, 2013
Days to Decision 221 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
133d slower than avg
Panel avg: 88d · This submission: 221d
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 236
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K123559.
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FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
K131013 · Nova Biomedical Corporation · Oct 2013
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