FDA product code JHY: Colorimetric Method, Cpk Or Isoenzymes
JHY is the FDA product code for colorimetric 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 40 510(k) submissions under JHY, from 32 different applicants. The average 510(k) review took 72 days (median 50). FDA has posted 2 recalls for JHY devices.
Classification
| Field | Value |
|---|---|
| Device name | Colorimetric 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 JHY clearance
Top JHY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hybritech, Inc. | 5 | 1992-06-09 |
| Roche Diagnostics | 2 | 2014-05-08 |
| Abbott Laboratories | 2 | 1993-06-15 |
| Roche Diagnostic Systems, Inc. | 2 | 1990-02-16 |
| Intl. Immunoassay Laboratories, Inc. | 2 | 1988-06-01 |
27 more applicants have JHY clearances. See the full list in Caduvo.
Most recent JHY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143720 | Siemens Healthcare Diagnostics | Dimension Vista MMB Assay | 2015-09-18 | 263 |
| K130080 | Medica Corporation | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL | 2014-05-13 | 484 |
| K140404 | Roche Diagnostics | ELECSYS CK-MB STAT IMMUNOASSAY | 2014-05-08 | 79 |
| K132571 | Roche Diagnostics | ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY | 2013-10-18 | 64 |
| K070835 | Olympus Life & Material Science Europa GmbH (Irish | OLYMPUS CK-MB REAGENT | 2007-06-04 | 69 |
Recalls for JHY devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-01-02.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code JHY?
JHY is the FDA product code for colorimetric 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 JHY?
Class II, regulation 21 CFR 862.1215. Typical premarket route: 510(k).
How long does a 510(k) take for product code JHY?
Across 40 cleared submissions the average was 72 days from receipt to decision (median 50).
Which companies have the most JHY clearances?
Hybritech, Inc. (5); Roche Diagnostics (2); Abbott Laboratories (2); Roche Diagnostic Systems, Inc. (2); Intl. Immunoassay Laboratories, Inc. (2).
Have JHY devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-01-02.
Next steps
- Run an FDA pathway report with predicate devices for product code JHY
- Run a recall and safety report across every JHY manufacturer
- Watch product code JHY 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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