Cleared Traditional

K132929 - SD GLUCONAVII MENTOR NFC MULTI BLOOD GL...

K132929 is the FDA 510(k) clearance for SD GLUCONAVII MENTOR NFC MULTI BLOOD GL... by Sd Biosensor, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 687-day FDA review.

K132929 · Sd Biosensor, Inc. · Chemistry device
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Aug 2015
Decision
687d
Days
Class 2
Risk

K132929 is an FDA 510(k) clearance for the SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCON.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Sd Biosensor, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on August 5, 2015 after a review of 687 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Sd Biosensor, Inc. devices

Submission Details

510(k) Number K132929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2013
Decision Date August 05, 2015
Days to Decision 687 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
599d slower than avg
Panel avg: 88d · This submission: 687d
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
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