AliveDx Nabs FDA Class II Registration for Syndromic Immunoassay Analyzer

Original from: 360dx

AliveDx said Tuesday that it has registered its multiplex immunoassay analyzer for autoimmune disease and allergy testing with the US Food and Drug Administration as a Class II device that is exempt from premarket authorization requirements.

The Eysins, Switzerland-based firm's MosaiQ fully automated microarray platform is used for syndromic testing, with the ability to test for 132 targets in two testing chambers of up to 66 analytes or parameters each. The company said that as a Class II 510(k) exempt medical device, the instrument can be used in clinical labs.

The Class II designation is used for moderate medical devices, and some products with that designation are exempt from 510(k) marketing clearance requirements.

The firm announced in April that it had submitted for FDA 510(k) marketing clearance its MosaiQ AiPlex Connective Tissue Diseases (CTDplus) microarray assay, which is CE-marked under the EU's In Vitro Diagnostic Regulation and used for the detection of 15 disease markers to aid the diagnosis of autoimmune rheumatic diseases. With FDA Class II registration for the MosaiQ instrument, AliveDx said that it will focus on preparing FDA 510(k) submissions for celiac disease, vasculitis, antiphospholipid syndrome, and allergen tests that are used with the MosaiQ instrument.

Formerly named Quotient Limited, the company recently underwent a shift in focus toward clinical testing from its origins in transfusion testing, and it plans to launch in the US and EU a menu of tests for autoimmune diseases and allergies.

Source: AliveDx Nabs FDA Class II Registration for Syndromic Immunoassay Analyzer