FDA product code JKM: Immunochemical, Bence-Jones Protein
JKM is the FDA product code for immunochemical, bence-jones protein. It is a Class II device, regulated under 21 CFR 866.5150 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under JKM, from 4 different applicants. The average 510(k) review took 184 days (median 172).
Classification
| Field | Value |
|---|---|
| Device name | Immunochemical, Bence-Jones Protein |
| Device class | Class II |
| Regulation | 21 CFR 866.5150 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JKM clearance
Top JKM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sebia | 1 | 2008-07-01 |
| Sebia, Inc. | 1 | 2007-12-21 |
| Beckman Coulter, Inc. | 1 | 2005-05-06 |
| Morax | 1 | 1998-03-04 |
Most recent JKM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080916 | Sebia | CAPILLARYS URINE | 2008-07-01 | 90 |
| K070486 | Sebia, Inc. | CAPILLARYS URINE (PN 2012) | 2007-12-21 | 304 |
| K050119 | Beckman Coulter, Inc. | PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT | 2005-05-06 | 108 |
| K972591 | Morax | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT | 1998-03-04 | 236 |
Recalls for JKM devices
openFDA lists no recalls for product code JKM.
Frequently asked questions
What is FDA product code JKM?
JKM is the FDA product code for immunochemical, bence-jones protein. It is a Class II device, regulated under 21 CFR 866.5150 and reviewed by the Immunology panel.
What device class is JKM?
Class II, regulation 21 CFR 866.5150. Typical premarket route: 510(k).
How long does a 510(k) take for product code JKM?
Across 4 cleared submissions the average was 184 days from receipt to decision (median 172).
Which companies have the most JKM clearances?
Sebia (1); Sebia, Inc. (1); Beckman Coulter, Inc. (1); Morax (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JKM
- Run a recall and safety report across every JKM manufacturer
- Watch product code JKM 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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