FDA grants 510(k) clearance to Werfen for Aptiva CTD Essential reagent

Original from: Medical Device Network

Werfen has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Aptiva Connective Tissue Disease (CTD) Essential reagent.​

A fully automated multi-analyte system, Aptiva utilises particle-based multi-analyte technology, which processes several analytes simultaneously from the sample of a single patient.

Aptiva CTD Essential reagent can deliver up to 600 results per hour, thereby allowing the laboratory to complete test volumes with minimal hands-on time.

It also represents the next generation of high-throughput systems designed for use in the clinical autoimmune laboratory, the company claims.

Werfen research and business development vice-president Michael Mahler said: “Aptiva CTD Essential, with its unique biomarker composition and high level of analytical and clinical performance, represents a breakthrough that fundamentally enhances the utility of diagnostic testing in the autoimmune laboratory.

“We are excited to bring this latest expansion of the Aptiva reagent menu to the US market, resulting in advanced patient care.”

Aptiva CTD Essential reagent complements the company’s Aptiva Celiac Disease reagent, which was cleared previously.

Besides CTD and Celiac Disease assays, Aptiva will target further autoimmune disease states and has over 60 analytes in different stages of advanced development.

These analytes have the potential to cut down on the time to diagnosis of autoimmune diseases and help in the better management of patients.​

Source: FDA grants 510(k) clearance to Werfen for Aptiva CTD Essential reagent