KHB Group and Technogenetics Celebrate FDA 510(k) Clearance of Three IDS Autoimmune CLIA Assays
On August 21, 2026, three autoimmune CLIA – IDS SS-A/Ro, IDS SS-A/Ro 60 kDa, and IDS SS-B/La – received U.S. Food and Drug Administration (FDA) 510(k) clearance under 510(k) No. K253817. The assays are manufactured by Technogenetics and supplied to Immunodiagnostic Systems Limited (IDS) as legal manufacturer under a long-standing OEM collaboration.
IDS, part of Revvity, Inc., contributes more than three decades of expertise in immunodiagnostics, including advanced random-access systems and specialty assays. The three assays, which are now added to the CLIA-based autoimmune diagnostic offerings in the United States, are intended for automated determination of human IgG against SS-A/Ro and SS-B/La to particularly aid in the diagnosis of the two autoimmune rheumatic diseases Systemic Lupus Erythematosus and Sjögren’s Syndrome.
“KHB Group is proud that Technogenetics has served as the OEM manufacturing and technology partner behind these three FDA-cleared IDS autoimmune assays. The achievement demonstrates how long-term cooperation and international expertise can deliver products that meet stringent regulatory and quality requirements,” says Mr Hyuk Shin Kang of KHB.
The clearance also strengthens Technogenetics' strategic role within KHB Group as its European platform for R&D, manufacturing, regulatory expertise and international collaboration, while reinforcing KHB's growing position as a global partner for high-quality chemiluminescence diagnostic solutions.
About KHB Group and Technogenetics
Founded in Shanghai in 1981, Shanghai Kehua Bio-engineering Co., Ltd. (KHB, 002022.SZ) became the first publicly listed IVD company in China when it was listed on the Shenzhen Stock Exchange in 2004. For more than four decades, KHB has played a pioneering role in China's diagnostic industry and has continuously expanded its expertise across immunodiagnostics, clinical chemistry, molecular diagnostics, mass spectrometry and point-of-care testing.
Chemiluminescence immunoassay represents one of KHB Group's core technology platforms. Through Technogenetics in Italy, the Group has built extensive experience in the development and manufacturing of specialty CLIA assays for international diagnostic partners.