Cleared Special

K121087 - CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM

K121087 is an FDA 510(k) clearance for CONTOUR NEXT USB BLOOD GLUCOSE MONITORI..., manufactured by Bayer Healthcare. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 79-day FDA review.

K121087 · Bayer Healthcare · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
79d
Days
Class 2
Risk

K121087 is an FDA 510(k) clearance for the CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bayer Healthcare (Mishawaka, US). The FDA issued a Cleared decision on June 28, 2012 after a review of 79 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bayer Healthcare devices

FDA 510(k) Submission Details - K121087

510(k) Number K121087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2012
Decision Date June 28, 2012
Days to Decision 79 days
Submission Type Special
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
9d faster than avg
Panel avg: 88d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01466075 Completed Interventional Industry-sponsored

Study of an Investigational Glucose Meter System

Clinical Study of the Apollo Evolution BGMS With Tatsu Blood Glucose Test Strips

207
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator David Simmons, MD
Sponsor Ascensia Diabetes Care (industry)
Started 2011-11-01 → Primary completion 2011-12-01
Primary outcome
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
Secondary outcome
Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
View full study on ClinicalTrials.gov

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 K121087.
HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
K113192 · Infopia Co, Ltd. · Jul 2012
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
K121133 · I-Sens, Inc. · Jul 2012
AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
K120649 · Apex BioTechnology Corp. · Jul 2012
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
K110074 · Health & Life Co., Ltd. · May 2012
ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
K120183 · Broadmaster Biotech Corperation · May 2012
CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA
K120351 · I-Sens, Inc. · May 2012