Cleared Special

K091820 - CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS

Also marketed or referenced as:
GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM

K091820 is an FDA 510(k) clearance for CONTOUR USB BLOOD GLUCOSE METER, 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 69-day FDA review.

K091820 · Bayer Healthcare · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
69d
Days
Class 2
Risk

K091820 is an FDA 510(k) clearance for the CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS. 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 August 26, 2009 after a review of 69 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.

FDA 510(k) Submission Details - K091820

510(k) Number K091820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2009
Decision Date August 26, 2009
Days to Decision 69 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 89d · This submission: 69d
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
NCT00797212 Completed Interventional Industry-sponsored

A New Glucose Meter With Alternative Site Testing

Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Alternative Site Testing [Commercial Name is CONTOUR® USB]

50
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes Mellitus
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Vimala Sethy, MD, PhD
Sponsor Ascensia Diabetes Care (industry)
Started 2008-11-01 → Primary completion 2008-11-01
Primary outcome
Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results
Secondary outcome
Percentage of Participants Rated as <=3 (Labeling Comprehension)
View full study on ClinicalTrials.gov

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K091820.
POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
K090653 · Arkray Factory USA, Inc. · Oct 2009
EOCENE SYSTEM
K090712 · Infopia Co, Ltd. · Oct 2009
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
K091898 · Taidoc Technology Corporation · Sep 2009
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
K091481 · Eps Bio Technology Corp. · Aug 2009
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
K090332 · Arkray Factory USA, Inc. · Aug 2009
GLUCOMANAGER DATA MANAGEMENT SOFTWARE
K091229 · Eps Bio Technology Corp. · Jul 2009
K091820 · CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS
Download PDF Bayer Healthcare