# 21-Hydroxylase Antibody (21-Ohab)
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PCG)
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