DeviceClearance

Product code PCG— Immunology

STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT

Classification name
21-Hydroxylase Antibody (21-Ohab)
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PCG under 21 CFR 866.5660, via openFDA

Market context for product code PCG

FDA has cleared 2 devices under product code PCG between 2012 and 2018, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PCG

Recent clearances under product code PCG

Data sourced from openFDA. This site is unofficial and independent of the FDA.