Cleared Traditional

K120423 - BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650

K120423 is an FDA 510(k) clearance for BIONIME RIGHTEST BLOOD GLUCOSE MONITORI..., manufactured by Bionime Corporation. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K120423 · Bionime Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
172d
Days
Class 2
Risk

K120423 is an FDA 510(k) clearance for the BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bionime Corporation (Mission Viejo, US). The FDA issued a Cleared decision on August 3, 2012 after a review of 172 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 Bionime Corporation devices

FDA 510(k) Submission Details - K120423

510(k) Number K120423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2012
Decision Date August 03, 2012
Days to Decision 172 days
Submission Type Traditional
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
84d slower than avg
Panel avg: 88d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K120423.
TEST, BLOOD GLUCOSE SYSTEM
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