Cleared Special

K093930 - DIDGET WORLD REPORTS

K093930 is an FDA 510(k) clearance for DIDGET WORLD REPORTS, manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 80-day FDA review.

K093930 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
80d
Days
Class 2
Risk

K093930 is an FDA 510(k) clearance for the DIDGET WORLD REPORTS. 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 March 12, 2010 after a review of 80 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. 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. Low regulatory complexity profile. 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 - K093930

510(k) Number K093930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date March 12, 2010
Days to Decision 80 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
8d faster than avg
Panel avg: 88d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

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
NCT00923975 Completed Interventional Industry-sponsored

Evaluation of DIDGET TM World Reports

Evaluation of Avatar Web Reports

51
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Timothy Bailey, MD
Sponsor Ascensia Diabetes Care (industry)
Started 2009-06-01 → Primary completion 2009-06-01
Primary outcome
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Secondary outcome
Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)
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 K093930.
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MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
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U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC
K092902 · Taidoc Technology Corporation · Mar 2010
ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
K093592 · Taidoc Technology Corporation · Feb 2010
EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
K092894 · Eps Bio Technology Corp. · Feb 2010