Cleared Special

K121190 - CONTOUR NEXT BLOOD GLUCOSE METER

K121190 is an FDA 510(k) clearance for CONTOUR NEXT BLOOD GLUCOSE METER, manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code LFR cleared through the Special 510(k) pathway after a 98-day FDA review.

K121190 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
98d
Days
Class 2
Risk

K121190 is an FDA 510(k) clearance for the CONTOUR NEXT BLOOD GLUCOSE METER. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on July 26, 2012 after a review of 98 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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, LLC devices

FDA 510(k) Submission Details - K121190

510(k) Number K121190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2012
Decision Date July 26, 2012
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

LFR Device Classification - Class 2, Special Controls

Product Code LFR Glucose Dehydrogenase, Glucose
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
NCT01474317 Completed Interventional Industry-sponsored

Study of an Investigational Glucose Meter System

Performance of the G3 Blood Glucose Monitoring System With TATSU Strip

226
Patients (actual)
2
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Robert Bernstein, MD, FACE
Sponsor Ascensia Diabetes Care (industry)
Started 2011-11-01 → Primary completion 2011-11-01
Primary outcome
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/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 - LFR Glucose Dehydrogenase, Glucose

All 56
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K121190.
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
K122688 · Nova Biomedical Corporation · Apr 2013
NOVA ONE BLOOD GLUCOSE MONITOR
K122435 · Nova Biomedical Corporation · Dec 2012
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
K121224 · Taidoc Technology Corporation · Sep 2012
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
K120042 · Taidoc Technology Corporation · May 2012
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K121207 · Eps Bio Technology Corp. · May 2012
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
K113768 · Taidoc Technology Corporation · Apr 2012