DeviceClearance

Product code OBE— Immunology

Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB

Classification name
Anti-Ss-A 52 Autoantibodies
Device class
Class 2
Regulation
21 CFR 866.5100
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

FDA classification definition

“The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.”

— U.S. Food and Drug Administration, device classification record for product code OBE under 21 CFR 866.5100, via openFDA

Market context for product code OBE

FDA has cleared 3 devices under product code OBE between 2007 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OBE

Recent clearances under product code OBE

Data sourced from openFDA. This site is unofficial and independent of the FDA.