FDA product code JKR: Radioimmunoassay, Calcitonin
JKR is the FDA product code for radioimmunoassay, calcitonin. It is a Class II device, regulated under 21 CFR 862.1140 and reviewed by the Clinical Chemistry panel. FDA has cleared 20 510(k) submissions under JKR, 1 in the last five years, from 13 different applicants. The average 510(k) review took 108 days (median 82); 266 days on average over the last three years. FDA has posted 1 recall for JKR devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Calcitonin |
| Device class | Class II |
| Regulation | 21 CFR 862.1140 |
| 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 JKR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 147 |
| 2026 | 1 | 266 |
Compare with all 510(k) review times · Search every JKR clearance
Top JKR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Systems Laboratories, Inc. | 4 | 1992-01-15 |
| Nichols Institute Diagnostics | 3 | 1997-05-21 |
| Scantibodies Laboratory, Inc. | 2 | 2006-08-30 |
| Diagnostic Products Corp. | 2 | 2002-12-09 |
| Roche Diagnostics GmbH | 1 | 2026-04-24 |
8 more applicants have JKR clearances. See the full list in Caduvo.
Most recent JKR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252431 | Roche Diagnostics GmbH | Elecsys Calcitonin | 2026-04-24 | 266 |
| K182012 | Axis-Shield Diagnostics Limited | ADVIA Centaur Calcitonin (CALCT) assay | 2018-12-21 | 147 |
| K132828 | Roche Diagnostics | ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 | 2013-12-04 | 86 |
| K060578 | Scantibodies Laboratory, Inc. | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) | 2006-08-30 | 177 |
| K023304 | Diagnostic Products Corp. | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL | 2002-12-09 | 67 |
Recalls for JKR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-09-18.
Frequently asked questions
What is FDA product code JKR?
JKR is the FDA product code for radioimmunoassay, calcitonin. It is a Class II device, regulated under 21 CFR 862.1140 and reviewed by the Clinical Chemistry panel.
What device class is JKR?
Class II, regulation 21 CFR 862.1140. Typical premarket route: 510(k).
How long does a 510(k) take for product code JKR?
Across 20 cleared submissions the average was 108 days from receipt to decision (median 82).
Which companies have the most JKR clearances?
Diagnostic Systems Laboratories, Inc. (4); Nichols Institute Diagnostics (3); Scantibodies Laboratory, Inc. (2); Diagnostic Products Corp. (2); Roche Diagnostics GmbH (1).
Have JKR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-09-18.
Next steps
- Run an FDA pathway report with predicate devices for product code JKR
- Run a recall and safety report across every JKR manufacturer
- Watch product code JKR 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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