Want to know more about Radiometer blood gas analyzers not requiring IQCP?

Radiometer meets CLIA requirements for IQCP

IQCP is not required for the ABL90 FLEX and ABL800 FLEX analyzers

On April 8, 2016, the Centers for Medicare & Medicaid (CMS) released a statement defining which on-board controls can be considered equivalent to external QC. For IQCP not to be required for an instrument, its on-board control system needs to:

  • Have a similar matrix to that of patient specimens
  • Be treated in the same manner as patient specimens
  • Go through all elements of the analytic process as applicable


Radiometer is proud to reconfirm our 2015 announcement that both the ABL90 FLEX and ABL800 FLEX blood gas analyzers meet the above requirements.

The two analyzers feature on-board control systems that use 3 or more levels of dedicated, NIST traceable QC material that tests the entire patient sample pathway, including the sample inlet, thus fulfilling the CLIA regulations for external quality control (Federal Register 493.1256c, 493.1267b, c).

What does this mean for labs with Radiometer blood gas analyzers?  Below we have summarized each product’s quality system to help you determine if an IQCP plan may be required.

ABL800 FLEX Series   

The ABL800 FLEX series of blood gas analyzers all use the AUTOCHECK system for quality control.  AUTOCHECK was found to be substantially equivalent to the manual quality control process by the FDA in 510(k) 992859.  Since the AUTOCHECK module treats the QC ampoules and sampling process exactly as if introduced manually.

Radiometer recommends: IQCP is NOT required for the ABL800 FLEX Series analyzer


The ABL90 FLEX blood gas analyzer utilizes the AQM system for quality management.  The heart of the system is three dedicated levels of NIST traceable quality control solutions contained in sealed pouches.  During the QC measurement process the QC materials are treated in the same manner as a patient sample, including the inlet probe, completely challenging the entire analytic process as would be done with a manual external QC solution.

Radiometer recommends: IQCP is NOT required for the ABL90 FLEX analyzer

ABL80 FLEX Series

The ABL80 FLEX series of analyzers utilizes the QC3 system for quality management.  This robust system provides a System Cycle which includes three levels of NIST traceable QC every 8 hours, a 30-minute System Check to further verify system performance and an Analysis Check with each patient sample to ensure accurate results.  Because the QC3 system does not process the internal QC solutions through the sample probe used for patient specimens.

Radiometer recommends: IQCP should be developed for the ABL80 FLEX Series analyzers

Determining the right solution for your laboratory

Ultimately, the decision to create an IQCP plan for your Radiometer analyzer must be made by your laboratories’ administration.  Discussions with CAP and Joint Commission indicate it will be important for your laboratory director to perform an eligibility determination to conclude if an IQCP plan is required for your laboratory instruments.  Please also consider the requirements of other accreditation bodies including your state’s department of health, if applicable.

Radiometer has created an IQCP tool to better assist you in the development of your plan. The tool can be downloaded by Radiometer customers through the customer web portal, www.MyRadiometer.com

Read more about our analyzers

ABL800 FLEX blood gas analyzer

Cookies are used on this website

Use of cookies
Confirm your account with Radiometer

Please enter a valid email

By submitting your e-mail you agree to the data policy notice
Radiometer is using Microsoft Azure Active Directory to authenticate customer access. If you are already registered you will be taken to Microsoft AD to sign in using your Microsoft AD credentials.
You are already registered
Radiometer is using Microsoft Azure AD to authenticate customer access. If you are already registered you will be taken to AZURE to sign in using your AZURE credentials.
Thank you

We will be sending an e-mail invitation to you shortly to sign in using Microsoft Azure AD.

Radiometer is using Microsoft Azure AD to authenticate customer access.

It seems that your e-mail is not registered with us

Radiometer is using Microsoft Azure AD to authenticate customer access. If your e-mail is not registered with us please click CONTINUE and we will guide you through the sign-in process.
We have previously sent an invitation by e-mail

Please click "Get started" in the e-mail to complete the registration process

Radiometer is using Microsoft Azure AD to authenticate customer access.

We were not able to process your request due to a communication error


It seems this account has not been given access to the portal

Radiometer is using Microsoft AZURE Active Directory to authenticate users

Radiometer uses Azure AD to provide our customers and partners secure access to documents, resources, and other services on our customer portal.

If your organization is already using Azure AD you can use the same credentials to access Radiometer's customer portal.

Key benefits

  • Allow the use of existing Active Directory credentials
  • Single-sign on experience
  • Use same credentials to access future services    

Request access

You will receive an invitation to access our services via e-mail when your request  has been approved.

When you accept the invitation, and your organization is already using AZURE AD, you can use the same credentials to access Radiometer's customer portal. Otherwise, a one-time password will be sent via e-mail to sign in.

Effective Date January 20th, 2023 (last updated January 20th, 2023)



Radiometer values your privacy and the protection of your personal data. This policy (“Policy”) explains how Radiometer its affiliates, subsidiaries or related companies, a full list of which can be located here (together, “Radiometer,”, “our”, “us,” or “we”), collects, uses, shares, transfers and processes data collected from or about you.

Personal Data” is any information that can be used to directly or indirectly identify an individual or that can be reasonably expected to link to an individual. This can include items such as name, address, telephone number, credit card details, email address, ID number, Internet Protocol (“IP”) address of an electronic device used by an individual, or other identifying code (even absent of other identifying information). Statistical and non-identifiable metric data are not considered Personal Data.

The Radiometer subsidiary, affiliate or related company with which you interact is, where applicable, the data controller (or equivalent under applicable law) responsible for the processing of your Personal Data. You can find a list of the relevant legal entities that act as data controllers in Appendix 1 to this Policy.


This Policy describes the types of Personal Data that we may collect, process or disclose about you and how you may govern this processing by exercising applicable legal rights. This Policy applies to both online and offline information collection, including your use of websites or subdomains operated by us, any mobile applications, when we provide products and/or services to you or notify you about prospective items of interest and in other situations where you interact with us in-person, by telephone or by mail where this Policy is posted or referenced.

There may be occasion where you have been provided with a circumstance-specific privacy notice that is separate from this policy, such as privacy notices for specific activities such as Recruitment. To the extent you were provided with a different notice, those notices apply and govern our interactions with you. If you provide Personal Data about parties other than yourself, you are responsible for ensuring their knowledge of how we will process their personal data, and, where applicable, obtaining any necessary consents required in advance.

We are committed to processing Personal Data in accordance with applicable laws. Please note that if you do not wish to provide your Personal Data to us, some products and/or services may become unavailable to you. Your use of any or all these platforms indicates you have been notified of our collection, use, transfer, and disclosure of your information as described in this Policy to the extent permitted by applicable law.

Read more