ABL800 FLEX with AQURE Connectivity
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142898 FDA 510(k)
- FDA Product Code
- CHL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1120 FDA 510(k)
- Regulation Number
- 862.1120 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ABL800 FLEX with AQURE Connectivity is an Electrode Measurement, Blood-Gases (Pco2, Po2) and Blood pH analyzer, classified as a Class II device. It measures arterial and venous blood gases, electrolytes, and metabolic parameters to assess acid-base balance, oxygenation status, and electrolyte concentrations. The device integrates automated sample handling and connectivity for streamlined clinical workflows in settings such as emergency departments, intensive care units, and critical care environments.
This analyzer is designed for single-use applications with disposable electrodes and cassettes, ensuring sterility and minimizing cross-contamination. It operates in clinical chemistry settings and is compatible with hospital information systems via AQURE connectivity. The device requires calibration and maintenance as specified in the manufacturer’s instructions, with regulatory clearance under FDA 510(k) K142898. Storage conditions and MRI safety are not specified in the provided data.
Frequently asked questions
What clinical parameters does the ABL800 FLEX with AQURE connectivity measure?
The ABL800 FLEX with AQURE connectivity measures arterial and venous blood gases (Pco2, Po2), blood pH, and electrolytes. These parameters are critical for assessing acid-base balance, oxygenation status, and electrolyte concentrations in patients, particularly in settings like emergency departments, intensive care units, and critical care environments.
How is the ABL800 FLEX with AQURE connectivity supplied and what does this mean for sterility?
The ABL800 FLEX is designed for single-use applications, utilizing disposable electrodes and cassettes. This design ensures sterility for each use, significantly reducing the risk of cross-contamination between patients and simplifying infection control protocols in clinical settings.
Can the ABL800 FLEX with AQURE connectivity integrate with hospital information systems?
Yes, the ABL800 FLEX includes AQURE connectivity, allowing it to integrate seamlessly with hospital information systems. This feature streamlines clinical workflows by enabling automated data transfer and reducing manual data entry, thereby improving efficiency and accuracy in patient monitoring.
Is the ABL800 FLEX with AQURE connectivity intended for reuse or single-use?
The ABL800 FLEX is explicitly designed for single-use applications. The disposable electrodes and cassettes are engineered to be used once per patient, ensuring sterility and minimizing the risk of contamination. This aligns with best practices for infection control in clinical chemistry settings.
What maintenance requirements does the ABL800 FLEX with AQURE connectivity have?
The ABL800 FLEX requires calibration and maintenance as outlined in the manufacturer’s instructions. Regular calibration ensures accurate and reliable measurement of blood gases, pH, and electrolytes, while maintenance procedures help sustain the device’s performance and longevity in clinical environments.
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: ABL800 FLEX blood gas analyzer - Radiometer, ABL800 FLEX blood gas analyzer - Radiometer America, PDF Formatting Solutions version 2 - RFBMS, RADIOMETER ABL800 FLEX OPERATOR'S MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142898 | Class II | Active |
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Manufacturer
- Manufacturer
- Radiometer Medical ApS
Sources (1)
- FDA 510(k) K142898 24 fields · synced Oct 1, 2026