510(k) K121046
K121046 is an FDA 510(k) premarket notification submitted by Kronus Market Development Associates, Inc. for the device "STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT". The FDA issued a decision of Substantially Equivalent on December 20, 2012. The device falls under product code PCG (21-Hydroxylase Antibody (21-Ohab)), a Class II device regulated under 21 CFR 866.5660. Kronus Market Development Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2012
- Date Received
- April 6, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- 21-Hydroxylase Antibody (21-Ohab)
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type
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.