PCG · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5660
Classification
FDA Product Code
PCG
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5660
Review panel
IM
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.