FDA product code JHS: Differential Rate Kinetic Method, Cpk Or Isoenzymes
JHS is the FDA product code for differential rate kinetic method, cpk or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel. FDA has cleared 38 510(k) submissions under JHS, from 29 different applicants. The average 510(k) review took 49 days (median 38). FDA has posted 11 recalls for JHS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1215 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JHS clearance
Top JHS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smithkline Diagnostics, Inc. | 4 | 1979-10-30 |
| Careside, Inc. | 2 | 1999-04-19 |
| Dupont Medical Products | 2 | 1994-08-02 |
| Intl. Immunoassay Laboratories, Inc. | 2 | 1988-09-30 |
| Eastman Kodak Company | 2 | 1986-06-27 |
24 more applicants have JHS clearances. See the full list in Caduvo.
Most recent JHS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160570 | Roche Diagnostics Operations (Rdo) | Creatine Kinase | 2016-05-25 | 86 |
| K102706 | SENTINEL CH. SpA | CKMB UDR ASSAY | 2011-08-19 | 333 |
| K082226 | Alfa Wassermann Diagnostic Technologies, Inc. | S40 CREATINE KINASE (CK) | 2008-09-18 | 42 |
| K062128 | Dade Behring, Inc. | THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS | 2006-08-21 | 26 |
| K990434 | Careside, Inc. | CARESIDE CKMB | 1999-04-19 | 67 |
Recalls for JHS devices
11 product recalls in 5 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2024-08-15.
| Year | Recalls |
|---|---|
| 2018 | 5 |
| 2020 | 3 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code JHS?
JHS is the FDA product code for differential rate kinetic method, cpk or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel.
What device class is JHS?
Class II, regulation 21 CFR 862.1215. Typical premarket route: 510(k).
How long does a 510(k) take for product code JHS?
Across 38 cleared submissions the average was 49 days from receipt to decision (median 38).
Which companies have the most JHS clearances?
Smithkline Diagnostics, Inc. (4); Careside, Inc. (2); Dupont Medical Products (2); Intl. Immunoassay Laboratories, Inc. (2); Eastman Kodak Company (2).
Have JHS devices been recalled?
Yes: 11 product recalls across 5 recall events; the most recent began 2024-08-15.
Next steps
- Run an FDA pathway report with predicate devices for product code JHS
- Run a recall and safety report across every JHS manufacturer
- Watch product code JHS 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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