Cleared Traditional

K072054 - RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM

K072054 is the FDA 510(k) clearance for RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM by Bionime Corporation. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K072054 · Bionime Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
217d
Days
Class 2
Risk

K072054 is an FDA 510(k) clearance for the RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bionime Corporation (Great Neck, US). The FDA issued a Cleared decision on February 28, 2008 after a review of 217 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

Submission Details

510(k) Number K072054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2007
Decision Date February 28, 2008
Days to Decision 217 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
129d slower than avg
Panel avg: 88d · This submission: 217d
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 K072054.
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING
K073494 · Taidoc Technology Corporation · Apr 2008
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
K073137 · Apex BioTechnology Corp. · Apr 2008
CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
K073119 · Taidoc Technology Corporation · Mar 2008
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM
K072784 · Taidoc Technology Corporation · Dec 2007
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225
K071493 · Taidoc Technology Corporation · Oct 2007
ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
K072543 · Lifescan, Inc. · Oct 2007