Abx Pentra 400, Calcium Cp, Creatinine Cp, Phosphorus Cp, Amylase Cp, Urine Con…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Horiba Abx
Identifiers
- 510(k) Number
- K070249 FDA 510(k)
- FDA Product Code
- CIC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1145 FDA 510(k)
- Regulation Number
- 862.1145 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ABX Pentra 400 is a clinical chemistry analyzer designed for the quantitative measurement of calcium, creatinine, phosphorus, and amylase in serum or plasma samples, as well as urine control testing. Classified under the nomenclature for biochemical analyzers, it performs colorimetric assays using cresolphthalein complexone for calcium determination and other validated methods for the remaining analytes. The system integrates automated sample processing and reagent delivery to enhance precision and throughput in laboratory settings.
This device is supplied as a modular component of the ABX Pentra 400 platform, intended for use in clinical chemistry laboratories under controlled conditions. It operates as a reusable analyzer with disposable reagent cartridges and cuvettes, adhering to IVDR and FDA 510(k) clearance requirements for substantially equivalent performance. The system is not MRI-compatible and requires proper storage at specified environmental conditions to maintain accuracy. Authorized under K070249, it complies with regulatory standards for clinical chemistry diagnostics, including registration numbers 8040374 and 2517506.
Frequently asked questions
What specific analytes does the ABX Pentra 400 measure, and how are they determined in the testing process?
The ABX Pentra 400 quantifies calcium, creatinine, phosphorus, and amylase in serum or plasma samples, along with urine control testing. Calcium is measured using a colorimetric assay with cresolphthalein complexone, while the other analytes rely on validated proprietary methods. The system automates sample processing and reagent delivery to improve accuracy and efficiency in clinical chemistry laboratories.
Is the ABX Pentra 400 analyzer itself reusable, or are there single-use components involved in its operation?
The ABX Pentra 400 analyzer is a reusable clinical chemistry platform designed for long-term use in laboratories. However, it requires disposable components, including reagent cartridges and cuvettes, to ensure precision and sterility during testing. These consumables are replaced per protocol to maintain performance and compliance.
What storage conditions must be followed to ensure the analyzer’s accuracy and functionality?
The ABX Pentra 400 must be stored under controlled environmental conditions to preserve its accuracy. While exact specifications aren’t detailed here, typical clinical chemistry analyzers require protection from extreme temperatures, humidity, and direct sunlight. Always refer to the manufacturer’s instructions for precise storage guidelines to avoid compromising performance.
Does the ABX Pentra 400 have any compatibility restrictions, such as MRI or other environmental factors?
The ABX Pentra 400 is explicitly stated as *not* MRI-compatible, meaning it should not be used or stored in MRI environments. Additionally, since it relies on automated sample processing and reagent delivery, proper laboratory setup—including electrical stability and controlled workflows—is essential for reliable operation.
What regulatory pathways does the ABX Pentra 400 follow for market authorization, and how does this affect its use?
The device is authorized under both FDA 510(k) clearance (with a determination of *substantially equivalent* performance) and the EU’s In Vitro Diagnostic Regulation (IVDR). This means it meets U.S. and EU standards for clinical chemistry analyzers, ensuring compliance with safety, performance, and manufacturing requirements. The regulatory route confirms its suitability for use in accredited laboratories under applicable guidelines.
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 | K070249 | Class II | Active |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (2)
- FDA 510(k) K070249 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026