AliveDx’s MosaiQ gains FDA Class II 510(k) exempt device status
The MosaiQ instrument is a next-generation, continuous random-access immunoassay platform offering labs automation, simple workflows, fast, multiplexed results and actionable insights for complex-to-diagnose conditions
1 Sept 2025
AliveDx, the global in-vitro diagnostics company dedicated to advancing patient care, has announced that its MosaiQ® instrument is registered with the U.S. Food and Drug Administration (FDA) as a Class II 510(k) exempt medical device. This marks a significant milestone for clinical laboratories in the United States, enabling adoption of a multiplexing, high-throughput, automated testing platform designed to deliver faster, more comprehensive results in autoimmune and allergy testing.
About the MosaiQ solution
The MosaiQ solution is a next-generation IVD solution for autoimmune diseases, allergies and beyond. The multiplexed, fully automated planar microarray platform enables syndromic testing for complex conditions. Designed with ease-of-use in mind, MosaiQ combines high throughput with continuous random access and delivers fast and accurate results addressing evolving expectations for laboratory efficiency.
Key benefits include:
- Simple workflow – Fully automated process with built-in QC and calibration lowering costs and increasing laboratory efficiency. Continuous random access enables patient sample in, result out in one single step.
- Fast results – Multiple tests from a single low-volume serum sample, with time-to-first patient result under one hour and consecutive patient panel results every 42 seconds.
- Actionable insights – Multiplex panels designed to support syndromic testing, detect comorbidities and streamline decision making for clinicians with comprehensive insights.
Regulatory milestone
The listing as a Class II 510(k) exempt medical device, authorizes the use of MosaiQ in U.S. clinical labs – a milestone that enables AliveDx to bring its innovative multiplexing system to clinicians and patients in the US. “We’re excited to enter the U.S market with our disruptive MosaiQ instrument” said Manuel O. Méndez, CEO of AliveDx. “This effort underscores our continued commitment in partnering with laboratories and clinicians to gain diagnostic insights which ultimately enables improved patient outcomes.”
MosaiQ Assays*
The MosaiQ system has the potential to offer a flexible menu of multiplex assays for autoimmune diseases and allergies, designed with key markers as per recommended clinical guidelines for:
- AiPlex® CTDplus* – A comprehensive panel (15 markers) for connective tissue diseases (e.g., RA, SLE, Sjögren’s, SSc) on one microarray.
- AiPlex® CD* – Celiac disease panel (5 markers) combining IgA and IgG markers on one microarray.
- AiPlex® VAS* – Vasculitis panel (3 markers), key autoantibody markers – MPO, PR3, and GBM on one microarray.
- AiPlex® APS** - Antiphospholipid Syndrome panel (4 markers) combining both IgM and IgG markers on one microarray.
- AllergyPlex® COMBO** – Up to 34 markers designed to cover the most clinically relevant allergens on one microarray.
- Additional panels targeting organ specific autoimmune diseases and more specific allergy components, and others are in development.
* These assays are not available for clinical testing purposes in the US, subject to US FDA 510(k) clearance.
** These assays are not available for clinical testing purposes, subject to IVDR CE-mark and US FDA 510 (k) clearance.
Following this important milestone, AliveDx will focus on preparing submissions to the U.S. Food and Drug Administration seeking 510(k) clearance for these assays on the MosaiQ system.