Cleared Traditional

K090628 - DIDGET BLOOD GLUCOSE METER

Also marketed or referenced as:
CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080

K090628 is an FDA 510(k) clearance for DIDGET BLOOD GLUCOSE METER, 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 270-day FDA review.

K090628 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
270d
Days
Class 2
Risk

K090628 is an FDA 510(k) clearance for the DIDGET BLOOD GLUCOSE METER, MODEL 6181. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on December 4, 2009 after a review of 270 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 - K090628

510(k) Number K090628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2009
Decision Date December 04, 2009
Days to Decision 270 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
182d slower than avg
Panel avg: 88d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

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
NCT00985257 Completed Interventional Industry-sponsored

Performance of a New Glucose Meter System in Children and Young Adults

Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults

123
Patients (actual)
2
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes
Study design Single group
Eligibility All sexes · 4 Years+
Principal investigator Timothy Bailey, MD
Sponsor Ascensia Diabetes Care (industry)
Started 2009-09-01 → Primary completion 2009-10-01
Primary outcome
Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method
View full study on ClinicalTrials.gov

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 K090628.
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
K091547 · Nova Biomedical Corp. · Jan 2010
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
K093035 · Taidoc Technology Corporation · Dec 2009
NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254
K092099 · Taidoc Technology Corporation · Dec 2009
LIPIDPRO SYSTEM
K090405 · Infopia Co, Ltd. · Dec 2009
GLUCO LAB AUTO CODING, MODEL IGM-0022
K091157 · Infopia Co, Ltd. · Nov 2009
EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009
K092887 · Eps Bio Technology Corp. · Oct 2009