FDA Product Code OBE: Anti-ss-a 52 Autoantibodies
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.
Leading manufacturers include Inova Diagnostics, Inc. and Zeus Scientific.
3
Total
3
Cleared
267d
Avg days
2007
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
417d
recently vs 193d historically
FDA 510(k) Cleared Anti-ss-a 52 Autoantibodies Devices (Product Code OBE)
3 devices
Cleared
May 08, 2026
Alegria Flash SSA-60
Zeus Scientific
Immunology
417d
Cleared
Mar 05, 2015
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
Inova Diagnostics, Inc.
Immunology
258d
Cleared
Apr 04, 2007
QUANTA LITE SS-A 52 ELISA
Inova Diagnostics, Inc.
Immunology
127d
About Product Code OBE - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code OBE since 2007, with 3 receiving FDA clearance (average review time: 267 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - OBE Product Code
Recent submissions under OBE have taken an average of 417 days to reach a decision - up from 193 days historically. Manufacturers should account for longer review timelines in current project planning.
OBE devices are reviewed by the Immunology panel. Browse all Immunology devices →