Cleared Traditional

K042678 - RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM

K042678 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 96-day FDA review.

K042678 · Bionime Corporation · Chemistry device
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Jan 2005
Decision
96d
Days
Class 2
Risk

K042678 is an FDA 510(k) clearance for the RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM. 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 January 3, 2005 after a review of 96 days - within the typical 510(k) review window.

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 K042678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2004
Decision Date January 03, 2005
Days to Decision 96 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
8d slower than avg
Panel avg: 88d · This submission: 96d
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 K042678.
CLEVER CHEK TD-4225, MODEL TD-4225
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CLEVER CHEK TD-3213
K042795 · Taidoc Technology Corporation · Mar 2005
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
K043158 · Bayer Healthcare, LLC · Dec 2004
ASCENSIA ELITE DIABETES CARE SYSTEM
K043311 · Bayer Healthcare, LLC · Dec 2004
ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
K042005 · Taidoc Technology Corporation · Aug 2004