PCG — 21-Hydroxylase Antibody (21-Ohab) Class II

FDA Device Classification

Classification Details

Product Code
PCG
Device Class
Class II
Regulation Number
866.5660
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Definition

For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K180607kronusSteroid 21-Hydroxylase Antibody (21-OHAb) ELISA KitNovember 23, 2018
K121046kronus market development associatesSTEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KITDecember 20, 2012