# K121046: Steroid 21-Hydroxylase Antibody (21-Ohab) Ria Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kronus Market Development Associates, Inc.
- Decided: Dec 20, 2012 after 258 days
- Product code: PCG (21-Hydroxylase Antibody (21-Ohab))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The KRONUS 21-flydroxylase Antibody (21-OHAb) RIA Assay Kit is for the semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The KRONUS Steroid 21-OHAb RIA 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 the more complex autoimmune polyglandular syndrome (APS), type I or 11. 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.

Source page: https://510kreport.com/device/K121046
Methodology: https://510kreport.com/methodology