Cleared Traditional

K060470 - ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151

Also marketed or referenced as:
ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080

K060470 is an FDA 510(k) clearance for ASCENSIA CONTOUR BLOOD GLUCOSE METER, manufactured by Bayer Healthcare. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K060470 · Bayer Healthcare · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
48d
Days
Class 2
Risk

K060470 is an FDA 510(k) clearance for the ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151. 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 April 12, 2006 after a review of 48 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.

FDA 510(k) Submission Details - K060470

510(k) Number K060470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2006
Decision Date April 12, 2006
Days to Decision 48 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
41d faster than avg
Panel avg: 89d · This submission: 48d
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 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K060470.
GLUCOPACK
K052469 · Healthpia America Corp. · Jun 2006
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
EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
K053312 · Bioptik Technology, Inc. · Mar 2006
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K053635 · Bionime Corporation · Feb 2006
K060470 · ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151
Download PDF FDA Summary Bayer Healthcare