FDA product code JHW: U.V. Method, Cpk Isoenzymes
JHW is the FDA product code for u.v. method, cpk isoenzymes. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel. FDA has cleared 27 510(k) submissions under JHW, from 18 different applicants. The average 510(k) review took 66 days (median 50). FDA has posted 2 recalls for JHW devices.
Classification
| Field | Value |
|---|---|
| Device name | U.V. Method, Cpk 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 JHW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 259 |
Compare with all 510(k) review times · Search every JHW clearance
Top JHW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intl. Immunoassay Laboratories, Inc. | 5 | 1991-10-23 |
| Harleco | 3 | 1981-06-25 |
| Elitechgroup | 2 | 2014-07-18 |
| Biochemical Trade, Inc. | 2 | 1994-11-21 |
| Abbott Laboratories | 2 | 1994-06-21 |
13 more applicants have JHW clearances. See the full list in Caduvo.
Most recent JHW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162526 | Roche Diagnostics | Creatine Kinase-MB | 2017-05-26 | 259 |
| K141265 | Elitechgroup | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT | 2014-07-18 | 64 |
| K122083 | Elitechgroup | ELITECH CLINICAL SYSTEMS CK NAC SL | 2012-08-22 | 37 |
| K023744 | Wiener Laboratories Saic | WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 | 2003-01-03 | 57 |
| K003158 | Roche Diagnostics Corp. | ROCHE DIAGNOSTICS CK-MB | 2000-12-18 | 69 |
Recalls for JHW devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-12.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code JHW?
JHW is the FDA product code for u.v. method, cpk isoenzymes. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel.
What device class is JHW?
Class II, regulation 21 CFR 862.1215. Typical premarket route: 510(k).
How long does a 510(k) take for product code JHW?
Across 27 cleared submissions the average was 66 days from receipt to decision (median 50).
Which companies have the most JHW clearances?
Intl. Immunoassay Laboratories, Inc. (5); Harleco (3); Elitechgroup (2); Biochemical Trade, Inc. (2); Abbott Laboratories (2).
Have JHW devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-12-12.
Next steps
- Run an FDA pathway report with predicate devices for product code JHW
- Run a recall and safety report across every JHW manufacturer
- Watch product code JHW 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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