FDA Product Code OIF: Tyrosine Phosphatase (ia-2) Autoantibody Assay
The Device Is Used For The Semi-quantitative Determination Of Autoantibodies Against Tyrosine Phosphatase (ia-2) In Human Serum As An Aid In The Diagnosis Of Type 1 Diabetes Mellitus (autoimmune Mediated Diabetes).
Leading manufacturers include Kronus, Inc..
3
Total
3
Cleared
308d
Avg days
2008
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Tyrosine Phosphatase (ia-2) Autoantibody Assay Devices (Product Code OIF)
3 devices
About Product Code OIF - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code OIF since 2008, with 3 receiving FDA clearance (average review time: 308 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
OIF devices are reviewed by the Chemistry panel. Browse all Chemistry devices →