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ABL90 FLEX

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122642

by Radiometer Medical ApS

Identifiers

510(k) Number
K122642 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 ABL90 FLEX is an Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph device, designed for the precise analysis of arterial and venous blood samples. It measures key parameters such as partial pressures of carbon dioxide (Pco2) and oxygen (Po2), pH, and other blood chemistry metrics to assess acid-base balance, oxygenation status, and metabolic function in clinical settings.

This device is intended for use in clinical chemistry laboratories and critical care environments, providing rapid results within 35 seconds from a minimal sample volume of 65 µL. Supplied as a reusable medical instrument, it requires proper calibration and maintenance as outlined in its operator manual. The ABL90 FLEX adheres to FDA 510(k) clearance under Special Review (K122642) and is classified under device class 2 (862.1120). Sterility and regulatory compliance are ensured through manufacturer validation processes.

Frequently asked questions

How quickly can the ABL90 FLEX provide results for arterial or venous blood samples, and what sample volume is required?

The ABL90 FLEX delivers rapid results within 35 seconds for arterial or venous blood samples. It requires only a minimal sample volume of 65 microliters (µL), making it efficient for clinical settings where sample size is a consideration.

Is the ABL90 FLEX designed for single-use or reusable applications, and what maintenance does it require?

The ABL90 FLEX is a reusable medical instrument, meaning it is built for repeated use in clinical chemistry laboratories and critical care environments. Like all reusable devices, it requires proper calibration and maintenance as outlined in the operator manual to ensure accurate and reliable performance over time.

What key blood chemistry metrics does the ABL90 FLEX measure, and how does this help clinicians?

The ABL90 FLEX measures partial pressures of carbon dioxide (Pco2) and oxygen (Po2), pH, and other blood chemistry parameters to assess a patient’s acid-base balance, oxygenation status, and metabolic function. These measurements are critical for diagnosing and managing conditions like respiratory failure, metabolic disorders, and electrolyte imbalances in critical care settings.

How is the sterility and regulatory compliance of the ABL90 FLEX ensured?

The ABL90 FLEX undergoes manufacturer validation processes to ensure sterility and compliance with regulatory standards. While the device itself is reusable and not sterile-packaged, its design and maintenance protocols are validated to meet FDA 510(k) clearance requirements, including Special Review (K122642), ensuring its safety and performance in clinical use.

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: Blood gas analyzer - ABL90 FLEX - Radiometer, ABL90 FLEX PLUS blood gas analyzer - Radiometer America, ABL90 FLEX PLUS blood gas analyzer - Radiometer, PDF ABL90 FLEX operator's manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Radiometer Medical ApS

Sources (1)

  • FDA 510(k) K122642 24 fields · synced Sep 19, 2026