Cleared Traditional

K043158 - ASCENSIA BRIO BLOOD GLUCOSE MONITORING ...

K043158 is an FDA 510(k) clearance for ASCENSIA BRIO BLOOD GLUCOSE MONITORING ..., manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K043158 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
37d
Days
Class 2
Risk

K043158 is an FDA 510(k) clearance for the ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Elkhart, US). The FDA issued a Cleared decision on December 22, 2004 after a review of 37 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 Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K043158

510(k) Number K043158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2004
Decision Date December 22, 2004
Days to Decision 37 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
51d faster than avg
Panel avg: 88d · This submission: 37d
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 307
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K043158.
FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
K050500 · Abbott Diabetes Care, Inc. · Jun 2005
CLEVER CHEK TD-3213
K042795 · Taidoc Technology Corporation · Mar 2005
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K042678 · Bionime Corporation · Jan 2005
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
PTS PANELS CHOL+GLU TEST PANEL
K041750 · Polymer Technology Systems, Inc. · Jul 2004