FDA product code JHX: Fluorometric Method, Cpk Or Isoenzymes
JHX is the FDA product code for fluorometric 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 48 510(k) submissions under JHX, 2 in the last five years, from 29 different applicants. The average 510(k) review took 73 days (median 48); 59 days on average over the last three years. FDA has posted 15 recalls for JHX devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Fluorometric 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 |
510(k) clearances per year for JHX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 286 |
| 2022 | 1 | 158 |
| 2024 | 1 | 59 |
Compare with all 510(k) review times · Search every JHX clearance
Top JHX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intl. Immunoassay Laboratories, Inc. | 5 | 1992-04-22 |
| Beckman Coulter, Inc. | 4 | 2024-02-16 |
| Diagnostic Products Corp. | 4 | 2004-01-21 |
| Corning Medical & Scientific | 4 | 1982-01-18 |
| Dade Behring, Inc. | 3 | 2005-09-08 |
24 more applicants have JHX clearances. See the full list in Caduvo.
Most recent JHX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K234005 | Beckman Coulter, Inc. | Access CK-MB | 2024-02-16 | 59 |
| K212648 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products CK-MB Reagent Pack | 2022-01-28 | 158 |
| K163462 | Radiometer Medical Aps | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | 2017-09-21 | 286 |
| K120326 | Radiometer Medical Aps | AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE | 2012-11-21 | 293 |
| K081360 | Mitsubishi Kagaku Iatron | PATHFAST CK-MB-II, PATHFAST MYO-II | 2009-08-17 | 459 |
Recalls for JHX devices
15 product recalls in 10 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-03-31.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JHX?
JHX is the FDA product code for fluorometric 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 JHX?
Class II, regulation 21 CFR 862.1215. Typical premarket route: 510(k).
How long does a 510(k) take for product code JHX?
Across 48 cleared submissions the average was 73 days from receipt to decision (median 48).
Which companies have the most JHX clearances?
Intl. Immunoassay Laboratories, Inc. (5); Beckman Coulter, Inc. (4); Diagnostic Products Corp. (4); Corning Medical & Scientific (4); Dade Behring, Inc. (3).
Have JHX devices been recalled?
Yes: 15 product recalls across 10 recall events; the most recent began 2025-03-31.
Next steps
- Run an FDA pathway report with predicate devices for product code JHX
- Run a recall and safety report across every JHX manufacturer
- Watch product code JHX 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times