FDA product code PCG: 21-Hydroxylase Antibody (21-Ohab)
PCG is the FDA product code for 21-hydroxylase antibody (21-ohab). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under PCG, from 2 different applicants. The average 510(k) review took 260 days (median 260).
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.
Classification
| Field | Value |
|---|---|
| Device name | 21-Hydroxylase Antibody (21-Ohab) |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PCG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 261 |
Compare with all 510(k) review times · Search every PCG clearance
Top PCG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kronus, Inc. | 1 | 2018-11-23 |
| Kronus Market Development Associates, Inc. | 1 | 2012-12-20 |
Most recent PCG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180607 | Kronus, Inc. | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit | 2018-11-23 | 261 |
| K121046 | Kronus Market Development Associates, Inc. | STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT | 2012-12-20 | 258 |
Recalls for PCG devices
openFDA lists no recalls for product code PCG.
Frequently asked questions
What is FDA product code PCG?
PCG is the FDA product code for 21-hydroxylase antibody (21-ohab). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is PCG?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code PCG?
Across 2 cleared submissions the average was 260 days from receipt to decision (median 260).
Which companies have the most PCG clearances?
Kronus, Inc. (1); Kronus Market Development Associates, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PCG
- Run a recall and safety report across every PCG manufacturer
- Watch product code PCG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times