ABX Pentra Creatinine 120 CP, Total Protein 100 CP, Multical N and P Controls, and Urine Control L/H
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Horiba Abx
Identifiers
- 510(k) Number
- K072115 FDA 510(k)
- FDA Product Code
- CGX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1225 FDA 510(k)
- Regulation Number
- 862.1225 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ABX Pentra Creatinine 120 CP, Total Protein 100 CP, Multical N and P Controls, and Urine Control L/H is a multiparameter clinical chemistry analyzer designed for quantitative in vitro measurement of creatinine, total protein, and urine controls. It employs alkaline picrate colorimetry (Jaffé method) for creatinine assays and is intended for use with human serum, plasma, and urine samples. The device supports diagnostic evaluation of renal function and protein metabolism.
This system is supplied as a reagent kit for use on the ABX Pentra platform, requiring calibration and control materials for accurate testing. It is classified as a Class II medical device under FDA regulations and complies with the In Vitro Diagnostic Regulation (IVDR). The controls and reagents are intended for single-use, with specified stability and storage conditions as outlined in the manufacturer’s instructions. No MRI safety or reusable components are indicated in the specifications.
Frequently asked questions
What types of samples can the ABX Pentra creatinine and protein reagent kit analyze, and how does it measure creatinine specifically?
The ABX Pentra creatinine and protein reagent kit is designed for quantitative measurement of creatinine and total protein in human serum, plasma, and urine samples. Creatinine is measured using alkaline picrate colorimetry (Jaffé method), a validated chemical reaction that produces a color change proportional to creatinine levels. This method is commonly used for assessing renal function and protein metabolism in clinical diagnostics.
Is this reagent kit single-use, and if so, what are the storage requirements to maintain its stability?
Yes, the controls and reagents in this kit are intended for single-use only. Stability and storage conditions are detailed in the manufacturer’s instructions, but generally, such reagents require refrigeration (typically between 2°C and 8°C) and protection from light to preserve accuracy and performance. Always follow the provided guidelines to avoid degradation.
What platform does this reagent kit operate on, and does it require additional calibration or control materials?
This reagent kit is designed exclusively for use on the ABX Pentra clinical chemistry analyzer platform. It requires calibration and control materials (such as Multical N and P Controls, and Urine Control L/H) to ensure accurate and reliable test results. These materials are part of the system’s workflow to validate performance before patient testing begins.
Are there any reusable components in this device, and if not, how does the single-use design impact workflow?
No reusable components are indicated for this device. The single-use design of reagents and controls eliminates cross-contamination risks and reduces the need for cleaning or maintenance between tests. This streamlines workflow by minimizing preparation time and ensuring consistent, traceable results for each batch of samples processed on the ABX Pentra platform.
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: ABX Pentra 120 - toolkits.horiba-abx.com, ABX Pentra Creatinine - Horiba, ABX Pentra 400 Reagents - HORIBA
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 | K072115 | Class II | Active |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (2)
- FDA 510(k) K072115 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026