FDA clears ALK’s AccuTest devices for allergy skin testing

The devices are engineered with smaller tine lengths and diameters to enhance precision and minimise patient discomfort.

RanjithKumar Dharma October 08 2024

ALK has received clearance from the US Food and Drug Administration (FDA) for its new AccuTest range of allergy skin testing devices.

The line includes the AccuTest-1, AccuTest-8 and AccuTest-10, alongside the AccuTest 48-well and 60-well allergen trays, designed to optimise allergy testing and diagnosis.

AccuTest-1 is a single skin prick testing device, while AccuTest-8 and AccuTest-10 are multi-head applicators with eight and ten heads, respectively.

These devices are engineered with smaller tine lengths and diameters to enhance precision and minimise patient discomfort.

Furthermore, the devices feature improved ergonomics such as a larger top surface and ribbed grip for uniform pressure and consistent results.

ALK Allergy Extract, diagnostics and life science business units executive director Jay Bates said: “We are proud of this important milestone underscoring our commitment to bringing innovative solutions to our customers and the millions of people who suffer from chronic allergies.

“The annual costs of allergies can or may be significant, adding clinical and economic burdens to the healthcare system. Identifying underlying allergen triggers through testing is the first step to effective diagnosis and treatment.”   

The AccuTest allergen well trays, which are compatible with both single prick and multi-head devices, have an air-tight locking mechanism to prevent contamination.

They also have a non-slip rubber bottom to ensure stability and accuracy during testing. AccuTest-1 is versatile and can be used with both the 48-well and 60-well allergen trays.

AccuTest-8 and AccuTest-10 are designed for easy integration with various testing panel needs. Their pronounced ribbed design ensures a secure grip, increased control and comfort for the practitioner during use.

Based in Denmark, ALK is engaged in the marketing of allergy immunotherapy treatments and other products and services.

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