PCGClass II

21-Hydroxylase Antibody (21-Ohab)

21 CFR 866.5660 / Immunology

PCG is the FDA product code for 21-Hydroxylase Antibody (21-Ohab), a class II device type, regulated under 21 CFR 866.5660. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2018-11-23, and no recalls.

Classification record

Product code: PCG
Device name: 21-Hydroxylase Antibody (21-Ohab)
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.
Regulation: 21 CFR 866.5660
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code PCG

By decision year

2 clearances under product code PCG with a decision year between 2012 and 2018, 2012 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code PCG by decision year
Year	Clearances
2012	1
2018	1

Applicants with the most clearances

Product code PCG

Applicants holding the most 510(k) clearances under product code PCG
Applicant	Clearances
Kronus Market Development Associates, Inc.	1
Kronus, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PCG

Recent recalls

Product code PCG

FDA records show no recalls under product code PCG.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)