Diamond Tokyo Boeki ISE Module Calibrator 1, 2, 1-2
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120591 FDA 510(k)
- FDA Product Code
- JIT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1150 FDA 510(k)
- Regulation Number
- 862.1150 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a secondary calibrator used for in vitro diagnostics, specifically designed to provide calibration points for sodium (Na+), potassium (K+), and chloride (Cl-) electrodes on the Tokyo Boeki Ion-Selective Electrode (ISE) Module. It ensures accurate measurement calibration in clinical chemistry applications by maintaining precise electrolyte concentrations for analytical consistency.
The Diamond Tokyo Boeki ISE Module Calibrator 1, 2, 1-2 is supplied as a single-use, non-sterile reagent for laboratory use. It is intended for storage at 8–25°C and has a shelf life of up to two years when stored under these conditions. Authorized under FDA 510(k) clearance (K120591) and IVDR compliance, it adheres to regulatory standards for secondary calibrators in clinical chemistry settings.
Frequently asked questions
What specific electrolytes does the Diamond Tokyo Boeki ISE Module Calibrator adjust calibration for, and why is this important in clinical chemistry?
The Diamond Tokyo Boeki ISE Module Calibrator is designed to provide calibration points for sodium (Na+), potassium (K+), and chloride (Cl-) electrodes on the Tokyo Boeki Ion-Selective Electrode (ISE) Module. This is important because accurate calibration of these electrolytes ensures precise and consistent measurement results in clinical chemistry, which are critical for diagnosing conditions like electrolyte imbalances, metabolic disorders, or renal function issues.
Is this calibrator intended for single-use or repeated use, and what storage conditions are required to maintain its shelf life?
The Diamond Tokyo Boeki ISE Module Calibrator is supplied as a single-use, non-sterile reagent. To preserve its shelf life of up to two years, it must be stored at temperatures between 8–25°C. Proper storage ensures the electrolyte concentrations remain stable and accurate for calibration.
What regulatory pathways has this calibrator undergone, and how does that affect its use in clinical settings?
The Diamond Tokyo Boeki ISE Module Calibrator has been authorized through FDA 510(k) clearance (K120591) and IVDR compliance, confirming it meets regulatory standards for secondary calibrators in clinical chemistry. This clearance ensures the device has been evaluated for safety and performance, allowing clinicians to rely on its accuracy for maintaining analytical consistency in electrolyte measurements.
Are there different models or variations of this calibrator, and if so, how do they differ?
The device is listed as the Diamond Tokyo Boeki ISE Module Calibrator 1, 2, 1-2, which suggests it may include multiple calibration points (e.g., individual calibrators for 1, 2, or a combined 1-2 setup) tailored for the Tokyo Boeki ISE Module. The exact variations aren’t detailed in the data, but the naming implies flexibility in calibration point selection for different analytical needs.
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: Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2, DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2… - FDA.report, PDF Diamond calibrator for Tokyo Boeki ISE Module are intended for in vitro ...
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K120591 | Class II | Active |
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Manufacturer
- Manufacturer
- DIAMOND DIAGNOSTICS Inc
- FDA Applicant
- Diamond Diagnostics, Inc.
Sources (2)
- FDA 510(k) K120591 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026