Cleared Traditional

K072054 - RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310

K072054 is an FDA 510(k) clearance for RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, 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 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

FDA 510(k) Submission Details - K072054

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
Combination Product No
PCCP Authorized No
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.

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 458
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K072054.
PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
K073118 · Diagnostic Devices, Inc. · Mar 2008
CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
K073119 · Taidoc Technology Corporation · Mar 2008
MAJOR III BLOOD GLUCOSE MONITORING SYSTEM
K072274 · Bestgen Biotech Corp. · Feb 2008
WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM
K073573 · Agamatrix · Jan 2008
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM
K072784 · Taidoc Technology Corporation · Dec 2007
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
K070053 · Eps Bio Technology Corp. · Dec 2007