FDA clears AccuTest allergy skin testing device

Key takeaways:

• AccuTest provides smaller tine lengths and diameters, which improve precision and lessen discomfort.
• AccuTest trays feature non-slip rubber bottoms for better stability.

ALK announced the FDA clearance of its new line of allergy skin testing devices and well trays, according to a company press release.

The line includes AccuTest-1, AccuTest-8 and AccuTest-10 allergy skin testing devices that serve to test and diagnose allergies. The line also includes the AccuTest 48-well and 60-well allergen trays.

“We are so excited to offer these new, innovative devices,” Jay Bates, executive director, allergy extract, diagnostics, and life science business units at ALK, told Healio. “The testing devices, paired with the well trays’ contamination prevention features, make the system a versatile and reliable tool for practitioners. We are confident the new AccuTest system will elevate the overall testing experience for both practitioners and patients.”

The AccuTest-1 single-prick testing device uses hardened plastic tines to ensure accuracy.

The eight-head AccuTest-8 and 10-head AccuTest-10 easily integrate into existing testing panels, Bates explained.

“Both multi-headed devices feature pronounced ribbing for a secure grip, and with larger top surface areas, facilitate uniform pressure application,” Bates said.

“With smaller tine lengths and diameters, our new device improves precision while minimizing discomfort for both practitioners and patients,” he continued. “The ergonomic design of the multi-head devices, AccuTest-8 and AccuTest-10, provide better control and comfort during use, ensuring uniform pressure for consistent and reliable results.”

The AccuTest well trays also offer compatibility with both single-prick and multi-head devices, providing flexibility and convenience in testing procedures, according to the press release.

“Additionally, the trays are equipped with non-slip rubber bottoms for added stability and feature air-tight locking mechanisms to prevent contamination,” Bates said.

The clearance is supported by a study that showed the lower device variability of AccuTest could increase the reliability of skin prick allergy testing results.

Reference:

• Sanchez-Gonzalez M S, et al. J Prev Complement Med. 2023;doi: 10.22034/ncm.2023.398971.1085.

For more information:

Jay Bates can be reached at jay.bates@alk.net.