Cleared Traditional

K042678 - RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM

K042678 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 96-day FDA review.

K042678 · Bionime Corporation · Chemistry device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K042678

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
Combination Product No
PCCP Authorized No
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.

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 K042678.
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
K051213 · Abbott Laboratories, Inc. · May 2005
BLOOD GLUCOSE MONITORING SYSTEM
K043543 · American Healthcare, Inc. · Apr 2005
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