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Didget World Reports

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093930

by Bayer HealthCare, LLC

Identifiers

510(k) Number
K093930 FDA 510(k)
FDA Product Code
NBW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1345 FDA 510(k)
Regulation Number
862.1345 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Didget World Reports is a diabetes management software program designed for viewing and printing reports of blood glucose readings. It functions as a data analysis tool, allowing healthcare professionals and patients to monitor and track glucose levels over time, facilitating better diabetes management through structured reporting and visualization of meter data.

The software is supplied as a standalone program for use with Bayer’s Didget blood glucose meters. It is intended for single-use by individual users and does not require sterilization. The device is regulated under FDA 510(k) clearance (K093930) as substantially equivalent to previously cleared diabetes management software, with no explicit MRI safety or sterility requirements stated. No details on physical sizes or storage conditions are provided in the regulatory data.

Frequently asked questions

What is Didget World Reports used for?

Didget World Reports is a diabetes management software program designed to help users—both patients and healthcare professionals—view, analyze, and print reports of blood glucose readings. It functions as a data analysis tool by organizing meter data from Bayer’s Didget blood glucose meters into structured reports and visualizations. This allows for better monitoring of glucose trends over time, supporting more informed diabetes management decisions.

How is Didget World Reports supplied and intended for use?

The software is supplied as a standalone program for installation on a computer. It is intended for single-use by individual users, meaning each user installs and operates their own copy. Unlike medical devices requiring sterilization, this software does not need to be sterilized as it is non-physical and designed for digital use only.

Does Didget World Reports require any special storage conditions?

Since Didget World Reports is a software program and not a physical device, it does not have specific storage requirements like temperature or humidity controls. However, the computer system on which it is installed should meet standard operational conditions for software use, such as adequate processing power and storage space.

Is Didget World Reports compatible with other blood glucose meters?

No, Didget World Reports is specifically designed to work with Bayer’s Didget blood glucose meters. It is not intended for use with other meter brands or models, as compatibility depends on the data transfer protocols and formats supported by the meter.

What regulatory pathway does Didget World Reports follow?

Didget World Reports is regulated under the FDA’s 510(k) clearance process, specifically classified under product code NBW (Clinical Chemistry). It was determined to be substantially equivalent to previously cleared diabetes management software, earning clearance with the reference number K093930. The decision was made by the Clinical Chemistry (CH) advisory committee in 2010.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Didget World Reports 510 (k) FDA Premarket Notification K093930 BAYER ..., DIDGET WORLD REPORTS (K093930) — FDA 510(k) | Innolitics, PDF Bayer HlealthCare - Food and Drug Administration, PDF K093930 DIDGET WORLD REPORTS - 510kdatabase.net

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bayer HealthCare, LLC

Sources (1)

  • FDA 510(k) K093930 24 fields · synced Oct 5, 2026