What is an Assay?


Even a simple, seemingly small word such as “assay” has a lot of depth. So, what is an assay and what does it test for? The original application of assay was in the context of determining metal purity and dates back to the Middle Ages.

While an assay is still a common term for metallurgical applications, in modern science, an assay can refer to any study which quantifies an unknown. In pharmacological parlance, an assay is often a test for purity and/or potency of the active agent. In combination medical device testing and 510(k) approval, there are standard assays that are mandated for every device of a given type (e.g. the ISO 10993 tests) and customized assays specific to the device, the implant type, and desired claims.

Depending on the intended claims of your device, there are three families of assays commonly executed at Lupine Medical:

  1. Anti-thrombic: In an anti-thrombic assay, Lupine Medical is your one stop shop. We do everything from design, validation, execution and processing on many anti-thrombic assays.


  1. Antimicrobial: Antimicrobial assays are designed specific for each device type. In general, these tests look for the number of viable organisms on or around the device (or both) after the device is exposed to a bolus of bacteria or yeast. The intent here is to determine the log reduction (e.g. percent reduction) that the device produces on the microorganisms compared to an untreated control. Anti-biofilm assays are a subset of antimicrobial test that are still in the early stages of gaining FDA approval.


  1. Drug Elution: The third assay is a drug elution (or release) into any of several eluents (solutions), saline, serum (animal or human), and/or whole blood. This type of assay looks specifically at the release kinetics of the drug into the various eluents. Drug elution kinetic testing is a critical test in 510(k) submissions for medical devices that include antimicrobial agents.


Understanding the 510(k) Process


So you have an idea to manufacture a new medical combination device. You’re excitement for how it could improve the lives of patients around the world quickly turns to anxiety as you forecast the steps moving from product to production.


FDA regulation when it comes to combination medical devices can be a daunting project to take on. Depending on your specific medical device submission, the Center for Devices and Radiological Health (CDRH) is split between the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological Health (OIR). Reviewed by the (CDRH), it sometimes takes reverse engineering the entire submission process to fully understand what’s required.


Do What You Do Best:

Before diving into the details, it’s important to remember that a process like the 510(k) is a tedious one requiring a good investment of time and resources. If you’re wanting to stick with what you want to do best, let us help you navigate these waters.


What is a 510(k)?

Straight from the pages of the U.S. Food and Drug Administration (FDA) guidelines: “section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket notification.” FDA.gov.


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