FDA product code CKG: Radioimmunoassay, Acth
CKG is the FDA product code for radioimmunoassay, acth. It is a Class II device, regulated under 21 CFR 862.1025 and reviewed by the Clinical Chemistry panel. FDA has cleared 30 510(k) submissions under CKG, 1 in the last five years, from 22 different applicants. The average 510(k) review took 97 days (median 72). FDA has posted 6 recalls for CKG devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Acth |
| Device class | Class II |
| Regulation | 21 CFR 862.1025 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CKG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 238 |
Compare with all 510(k) review times · Search every CKG clearance
Top CKG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nichols Institute Diagnostics | 3 | 1996-12-24 |
| Diagnostic Systems Laboratories, Inc. | 3 | 1990-03-01 |
| Scantibodies Laboratory, Inc. | 2 | 2005-05-20 |
| Diagnostic Products Corp. | 2 | 1996-02-16 |
| Immuno Nuclear Corp. | 2 | 1985-03-21 |
17 more applicants have CKG clearances. See the full list in Caduvo.
Most recent CKG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223867 | Immunodiagnostic Systems Limited | IDS ACTH II | 2023-08-18 | 238 |
| K111335 | Tosoh Bioscience, Inc. | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 | 2011-12-01 | 203 |
| K060585 | Roche Diagnostics Corp. | ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH | 2006-05-03 | 57 |
| K050748 | Scantibodies Laboratory, Inc. | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | 2005-05-20 | 59 |
| K021032 | Scantibodies Laboratory, Inc. | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | 2002-06-03 | 66 |
Recalls for CKG devices
6 product recalls in 4 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code CKG?
CKG is the FDA product code for radioimmunoassay, acth. It is a Class II device, regulated under 21 CFR 862.1025 and reviewed by the Clinical Chemistry panel.
What device class is CKG?
Class II, regulation 21 CFR 862.1025. Typical premarket route: 510(k).
How long does a 510(k) take for product code CKG?
Across 30 cleared submissions the average was 97 days from receipt to decision (median 72).
Which companies have the most CKG clearances?
Nichols Institute Diagnostics (3); Diagnostic Systems Laboratories, Inc. (3); Scantibodies Laboratory, Inc. (2); Diagnostic Products Corp. (2); Immuno Nuclear Corp. (2).
Have CKG devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code CKG
- Run a recall and safety report across every CKG manufacturer
- Watch product code CKG 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.
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