Cleared Traditional

K053635 - MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM

K053635 is an FDA 510(k) clearance for MODIFICATION TO RIGHTEST BLOOD GLUCOSE ..., 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 54-day FDA review.

K053635 · Bionime Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
54d
Days
Class 2
Risk

K053635 is an FDA 510(k) clearance for the MODIFICATION TO 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 February 21, 2006 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bionime Corporation devices

FDA 510(k) Submission Details - K053635

510(k) Number K053635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2005
Decision Date February 21, 2006
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
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 K053635.
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
K061118 · Lifescan, Inc. · May 2006
G4, MODEL IGM-0004
K051651 · U. S. Diagnostics, Inc. · Apr 2006
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
K051839 · Abbott Diabetes Care, Inc. · Mar 2006
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
K053529 · Lifescan, Inc. · Jan 2006
GLUCODR SUPERSENSOR SYSTEM
K050985 · All Medicus Co., Ltd. · Oct 2005
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
K051514 · Hypoguard USA, Inc. · Oct 2005