FDA product code JKD: Radioimmunoassay, C-Peptides Of Proinsulin
JKD is the FDA product code for radioimmunoassay, c-peptides of proinsulin. It is a Class I device, regulated under 21 CFR 862.1135 and reviewed by the Clinical Chemistry panel. FDA has cleared 10 510(k) submissions under JKD, from 9 different applicants. The average 510(k) review took 122 days (median 107). FDA has posted 5 recalls for JKD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, C-Peptides Of Proinsulin |
| Device class | Class I |
| Regulation | 21 CFR 862.1135 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JKD clearance
Top JKD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 2 | 1995-03-23 |
| Tosoh Medics, Inc. | 1 | 1996-02-13 |
| Diagnostic Systems Laboratories, Inc. | 1 | 1990-05-24 |
| Institut National Des Radioelements | 1 | 1984-09-06 |
| Serono Diagnostics, Inc. | 1 | 1984-04-13 |
4 more applicants have JKD clearances. See the full list in Caduvo.
Most recent JKD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951848 | Tosoh Medics, Inc. | AIA-PACK CPR ASSAY | 1996-02-13 | 298 |
| K943767 | Diagnostic Products Corp. | IMMULITE C-PEPTIDE | 1995-03-23 | 233 |
| K896420 | Diagnostic Systems Laboratories, Inc. | DSL C-PEPTIDE RIA (DSL #7000) | 1990-05-24 | 197 |
| K854066 | Diagnostic Products Corp. | DOUBLE ANTIBODY C-PEPTIDE RIA KIT | 1985-11-12 | 39 |
| K842267 | Institut National Des Radioelements | C-PEP-RIA-100 | 1984-09-06 | 90 |
Recalls for JKD devices
5 product recalls in 4 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2021-12-21.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2020 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code JKD?
JKD is the FDA product code for radioimmunoassay, c-peptides of proinsulin. It is a Class I device, regulated under 21 CFR 862.1135 and reviewed by the Clinical Chemistry panel.
What device class is JKD?
Class I, regulation 21 CFR 862.1135. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JKD?
Across 10 cleared submissions the average was 122 days from receipt to decision (median 107).
Which companies have the most JKD clearances?
Diagnostic Products Corp. (2); Tosoh Medics, Inc. (1); Diagnostic Systems Laboratories, Inc. (1); Institut National Des Radioelements (1); Serono Diagnostics, Inc. (1).
Have JKD devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2021-12-21.
Next steps
- Run an FDA pathway report with predicate devices for product code JKD
- Run a recall and safety report across every JKD manufacturer
- Watch product code JKD 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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