Fora Diamond Prima Blood Glucose Monitoring System, Fora Diamond Mini Blood Glucose Monitoring System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111890 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)
The Fora Diamond Prima and Mini Blood Glucose Monitoring Systems are portable, in-vitro diagnostic devices designed for the quantitative measurement of glucose levels in human whole blood. Classified under the product code NBW, these systems are intended for use in clinical chemistry applications, providing accurate blood glucose readings to support diabetes management.
These systems are supplied as single-use or reusable components, depending on the specific test strips and meters, and are regulated under both FDA 510(k) clearance (K111890) and the EU In Vitro Diagnostic Device Directive (IVDD). The meters are intended for use in home healthcare, clinical laboratories, and point-of-care settings, with no specific MRI safety restrictions noted. Storage conditions and sterility are manufacturer-specified, though exact details are not provided in the regulatory data.
Frequently asked questions
What clinical settings can the Fora Diamond Prima and Mini systems be used in, and how does their portability factor into their use?
The Fora Diamond Prima and Mini Blood Glucose Monitoring Systems are designed for use in home healthcare, clinical laboratories, and point-of-care settings, making them versatile for both professional and patient self-monitoring. Their portability is a key feature, allowing for convenient glucose measurement in diverse environments, such as hospitals, doctor’s offices, or at home, without requiring fixed infrastructure.
Are the test strips and meters for these systems single-use or reusable, and how does this affect their practical use?
The Fora Diamond systems include single-use or reusable components, depending on the specific test strips and meters. Single-use strips ensure hygiene and eliminate cross-contamination risks, ideal for clinical or shared settings, while reusable meters extend cost efficiency for frequent users. The manufacturer’s instructions should clarify which parts are disposable and which can be reused, as this impacts maintenance and operational workflows.
What regulatory pathways have these devices undergone, and what does that mean for their adoption in the U.S. and Europe?
The Fora Diamond Prima and Mini systems have undergone FDA 510(k) clearance (K111890) and compliance with the EU In Vitro Diagnostic Device Directive (IVDD). This means they are legally authorized for use in the U.S. under FDA regulations and in the EU under IVDD standards, ensuring they meet required safety, performance, and quality benchmarks for blood glucose monitoring in both markets.
How do I determine the correct storage conditions for these devices, and why is this important?
While the exact storage conditions aren’t detailed in the regulatory data, proper storage is critical to maintaining accuracy and reliability of the glucose readings. Typically, such devices require protection from extreme temperatures, humidity, and direct sunlight. The manufacturer’s instructions (often included in the packaging or user manual) will specify these details, as improper storage could lead to inaccurate results or device malfunction.
Are there any size or model variations for the Fora Diamond systems, and how might this affect my selection?
The data provided lists two models: the Fora Diamond Prima and the Fora Diamond Mini. While specific size or feature differences aren’t detailed, the naming suggests the Mini may be a more compact or portable version of the Prima. Clinicians or users should compare the intended use cases, portability needs, and any additional features (e.g., display size, connectivity) outlined in the manufacturer’s documentation to select the model that best fits their requirements.
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: FORA Deutschland – ForaCare Europe, FORA 6 Multiparameter – ForaCare Europe, Fora AB - fora.se
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K111890 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (2)
- FDA 510(k) K111890 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026