Cleared Traditional

K110587 - CONTOUR LINK BLOOD GLUCOSE METER

K110587 is an FDA 510(k) clearance for CONTOUR LINK BLOOD GLUCOSE METER, manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K110587 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
393d
Days
Class 2
Risk

K110587 is an FDA 510(k) clearance for the CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR .... 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 March 28, 2012 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K110587

510(k) Number K110587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2011
Decision Date March 28, 2012
Days to Decision 393 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
305d slower than avg
Panel avg: 88d · This submission: 393d
Pathway characteristics
Predicate-based equivalence.

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
NCT01328717 Completed Interventional Industry-sponsored

Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial

Clinical Trial Protocol for Contour Link System With Contour Sensor

78
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 2010-12-01 → Primary completion 2010-12-01
Primary outcome
Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method
Secondary outcome
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)
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 K110587.
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
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
K113243 · Eps Bio Technology Corp. · Mar 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
K111874 · Abbott Laboratories · Feb 2012
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K112901 · Eps Bio Technology Corp. · Dec 2011