FDA product code JHT: Chromatographic Separation, Cpk Isoenzymes
JHT is the FDA product code for chromatographic separation, cpk isoenzymes. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel. FDA has cleared 21 510(k) submissions under JHT, from 15 different applicants. The average 510(k) review took 71 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Chromatographic Separation, 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 |
Compare with all 510(k) review times · Search every JHT clearance
Top JHT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intl. Immunoassay Laboratories, Inc. | 4 | 1990-05-15 |
| Helena Laboratories | 3 | 1993-04-12 |
| Coulter Electronics, Inc. | 2 | 1990-12-13 |
| Spectral Diagnostics, Inc. | 1 | 2002-09-30 |
| Princeton BioMeditech Corp. | 1 | 1999-05-28 |
10 more applicants have JHT clearances. See the full list in Caduvo.
Most recent JHT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022409 | Spectral Diagnostics, Inc. | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST | 2002-09-30 | 68 |
| K991299 | Princeton BioMeditech Corp. | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI | 1999-05-28 | 52 |
| K930359 | Helena Laboratories | CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 | 1993-04-12 | 76 |
| K904721 | Diagnostic Systems Laboratories, Inc. | DSL CK-MB (DSL #3200) | 1990-12-13 | 56 |
| K904866 | Coulter Electronics, Inc. | COULTER CK-MB ISOENZYME REAGENT | 1990-12-13 | 45 |
Recalls for JHT devices
openFDA lists no recalls for product code JHT.
Frequently asked questions
What is FDA product code JHT?
JHT is the FDA product code for chromatographic separation, 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 JHT?
Class II, regulation 21 CFR 862.1215. Typical premarket route: 510(k).
How long does a 510(k) take for product code JHT?
Across 21 cleared submissions the average was 71 days from receipt to decision (median 52).
Which companies have the most JHT clearances?
Intl. Immunoassay Laboratories, Inc. (4); Helena Laboratories (3); Coulter Electronics, Inc. (2); Spectral Diagnostics, Inc. (1); Princeton BioMeditech Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JHT
- Run a recall and safety report across every JHT manufacturer
- Watch product code JHT 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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