Pentra C200 ISE Module and ABX Pentra Glucose HK CP Reagent
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103788 FDA 510(k)
- FDA Product Code
- CFR 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 Pentra C200 ISE Module and ABX Pentra Glucose HK CP Reagent is a diagnostic device designed for clinical chemistry applications. It includes an ion-selective electrode (ISE) module for electrolyte analysis and a hexokinase-based reagent for glucose measurement, enabling precise biochemical testing in laboratory settings.
This device is intended for use in clinical laboratories and is supplied as a combination of a reusable ISE module and single-use reagent cartridges. It is authorized under FDA 510K and IVDR regulations, with a classification as a Class II medical device. The ISE module requires proper calibration and maintenance, while the glucose reagent cartridges are designed for single-use to ensure accuracy and sterility.
Frequently asked questions
What types of biochemical tests can the Pentra C200 system perform, and how are they conducted?
The Pentra C200 system is designed for clinical chemistry applications, specifically for electrolyte analysis via its ion-selective electrode (ISE) module and glucose measurement using a hexokinase-based reagent. The ISE module measures electrolytes like sodium, potassium, and chloride, while the single-use glucose reagent cartridges provide precise glucose readings through a biochemical reaction. Both components work together in a laboratory setting to deliver accurate results for patient diagnostics.
Is the ISE module reusable, and if so, what maintenance does it require?
Yes, the ISE module is reusable. However, it requires proper calibration and maintenance to ensure accurate and reliable electrolyte measurements over time. The manufacturer recommends following their guidelines for cleaning, storage, and periodic recalibration to maintain performance.
Are the glucose reagent cartridges sterile, and how should they be stored?
The glucose reagent cartridges are designed for single-use to ensure sterility and accuracy. They should be stored according to the manufacturer’s instructions, typically in a cool, dry place away from direct sunlight and extreme temperatures. Proper storage conditions help preserve their integrity and performance until use.
What regulatory pathways has this device undergone, and what does that mean for its use in clinical settings?
The Pentra C200 ISE Module and ABX Pentra Glucose HK CP Reagent has been authorized under both FDA 510K and IVDR (In Vitro Diagnostic Regulation) pathways. This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device (FDA) and compliance with EU regulatory standards (IVDR), ensuring its safety, performance, and suitability for clinical chemistry testing in authorized laboratories.
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.
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 | K103788 | Class II | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
Sources (2)
- FDA 510(k) K103788 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026