Cleared Special

K150396 - Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips

K150396 is an FDA 510(k) clearance for Autosure Voice II Blood Glucose Monitor..., manufactured by Apex BioTechnology Corp.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 238-day FDA review.

K150396 · Apex BioTechnology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
238d
Days
Class 2
Risk

K150396 is an FDA 510(k) clearance for the Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Bloo.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Apex BioTechnology Corp. (Hsinchu, CN). The FDA issued a Cleared decision on October 14, 2015 after a review of 238 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Apex BioTechnology Corp. devices

FDA 510(k) Submission Details - K150396

510(k) Number K150396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date October 14, 2015
Days to Decision 238 days
Submission Type Special
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
150d slower than avg
Panel avg: 88d · This submission: 238d
Pathway characteristics
Modification to existing cleared device.

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 420
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K150396.
Contour Next USB Blood Glucose Monitoring System
K150942 · Bayer Healthcare · Nov 2015
SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System
K151265 · Sd Biosensor · Nov 2015
Gmate SMART Blood Glucose Monitoring System
K150299 · Philosys, Inc. · Nov 2015
Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System
K140325 · Joinsoon Medical Technology Co, Ltd. · Oct 2015
GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM
K141656 · Philosys, Inc. · Oct 2015
FreeStyle Precision Neo Blood Glucose Monitoring System
K142928 · Abbott Diabetes Care, Inc. · Sep 2015