Andon Health's iHealth Labs secures FDA 510(K) nod for combo test kits

Tianjin Andon Health Electronics Co., Ltd. (Andon Health) announced on December 13, 2025, that its U.S. subsidiary, iHealth Labs Inc., received FDA 510(K) premarket notifications for several diagnostic products. These include quadrivalent test kits for influenza A&B, COVID-19, and RSV, for both home and professional use, and trivalent test kits for influenza A&B and COVID-19, also for home and professional use. These approvals enable the products to be legally sold in the U.S. market.

The FDA 510(K) clearances represent a significant expansion for Andon Health, enhancing its IVD product line and strengthening its core competitiveness. Unlike products approved under Emergency Use Authorization (EUA), these 510(K) cleared products are not subject to EUA expiration, ensuring continuous market access. The quadrivalent tests are for individuals aged six months and above, while the trivalent tests are for individuals aged two years and above.

Andon Health cautions that the actual sales performance of these products will depend on future market demand, competition, and exchange rate fluctuations, making it difficult to predict their impact on the company’s future financial performance. Investors are advised to exercise caution.