Cleared Special

K153201 - SD GlucoNavii Mentor BT Blood Glucose M...

K153201 is the FDA 510(k) clearance for SD GlucoNavii Mentor BT Blood Glucose M... by Sd Biosensor. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 233-day FDA review.

K153201 · Sd Biosensor · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
233d
Days
Class 2
Risk

K153201 is an FDA 510(k) clearance for the SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Sd Biosensor (Suwon-Si, KR). The FDA issued a Cleared decision on June 24, 2016 after a review of 233 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 Sd Biosensor devices

Submission Details

510(k) Number K153201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2015
Decision Date June 24, 2016
Days to Decision 233 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 88d · This submission: 233d
Pathway characteristics
Modification to existing cleared device.

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
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