PCG

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

21-Hydroxylase Antibody (21-Ohab)

Device class

Class II (moderate risk)

Regulation

21 CFR 866.5660

Medical specialty

Immunology

Flags

Third-party review eligible

FDA 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.

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