Cleared Traditional

K122307 - DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITOR...

K122307 is the FDA 510(k) clearance for DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITOR... by Biocare Corporation. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K122307 · Biocare Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
247d
Days
Class 2
Risk

K122307 is an FDA 510(k) clearance for the DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Biocare Corporation (Taoyuan County, TW). The FDA issued a Cleared decision on April 5, 2013 after a review of 247 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 Biocare Corporation devices

Submission Details

510(k) Number K122307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2012
Decision Date April 05, 2013
Days to Decision 247 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
159d slower than avg
Panel avg: 88d · This submission: 247d
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 K122307.
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K113614 · Roche Diagnostics · Feb 2013