Interpreting FDA Guidelines For Luminex Multiplex Immunoassay Validation

A mandatory self-check of your software and devices for compliance with FDA guidelines is a requirement in the Food and Drug Administration’s (FDA) Critical Path Based Validation System. The Luminex Multiplex Immunoassay is an FDA-approved device, making it a good candidate for automatic validation. This paper covers how this process can be done using Luminex’s system, but it also provides guidance on how to run the self-checks when using other technologies or instrumentation.

The FDA specifies that for a device to be validated, any software used with the device must also be validated.

The Need for Validation Is Purely Scientific

In general practice, the need for validation is universally accepted in the scientific community. However, when it comes to software validation, only a few people know   of what is involved in doing so. Nevertheless, if one wishes to sell or use their software within the United States or its territories, then it must be FDA-compliant. It still applies, whether one sells their software in packages with the equipment they manufacture or  licenses their software for sale on disks and/or used with other instruments.

Further,  the purpose of FDA guidelines, which are implemented through the Critical PathBased Validation System (CPVS), is to ensure that new technologies do not pose an unacceptable risk to human health. FDA guidelines are implemented through the Critical PathBased Validation System – a certification program – for  instrument manufacturers and resellers.

The Safety Assurance of the Device is Extremely Precautionary

As part of this process, a device must be validated, meaning it must be shown consistently meets US FDA standards for safety and performance at every step in the validation process. Users must also validate their software used with each instrument against these standards. The  most crucial  aspect of device validation is that users must check all aspects of software used with their devices against FDA standards.

For example, the FDA requires that the software must be tested against this specification:

The language is quite detailed, but it does not take much effort to figure out what is required. One  should  note that Device Specific Software manufacturers are responsible for testing their software against these standards. So, it is essential  to read the technical specifications thoroughly with Multiplex assay.  Other items specified by the FDA,  can be found in Annexure A of this document, which outlines the general requirements applicable to all instruments manufactured.

Suffice to say that validation starts with ensuring that all equipment used with your device meets the specifications. This goes for any pieces of unique equipment or packages sold together with your unique software, even if you do not manufacture them. You may not be able to manufacture them yourself, but you still need to validate that they meet the specifications.

Luminex Software Must Be Validated Against

Since its inception in 2001, the FDA has required that the validation of instruments and their associated operating software and other computerized components use a risk-based approach. This is known as the Critical PathBased Validation System (CPVS). This system is implemented by instrument manufacturers and resellers who sell equipment within the US or its territories. As part of this process, a device must be validated, meaning it must be shown consistently meets FDA standards for safety and performance at every step in the validation process.

To conclude, it must be brought to the fore that not all FDA standards need to be followed by every company. It is up to the individual companies to decide how they will comply  with these guidelines and what their policies will be.

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