FDA product code JPZ: Colorimetric Method, Gamma-Glutamyl Transpeptidase
JPZ is the FDA product code for colorimetric method, gamma-glutamyl transpeptidase. It is a Class I device, regulated under 21 CFR 862.1360 and reviewed by the Clinical Chemistry panel. FDA has cleared 33 510(k) submissions under JPZ, from 28 different applicants. The average 510(k) review took 51 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Colorimetric Method, Gamma-Glutamyl Transpeptidase |
| Device class | Class I |
| Regulation | 21 CFR 862.1360 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JPZ clearance
Top JPZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Data Medical Associates, Inc. | 3 | 1996-07-01 |
| Wako Chemicals USA, Inc. | 2 | 1989-11-08 |
| Technostics Intl. | 2 | 1986-01-14 |
| Harleco | 2 | 1978-03-09 |
| Careside, Inc. | 1 | 2002-07-01 |
23 more applicants have JPZ clearances. See the full list in Caduvo.
Most recent JPZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020486 | Careside, Inc. | CARESIDE GGT | 2002-07-01 | 138 |
| K961919 | Data Medical Associates, Inc. | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | 1996-07-01 | 45 |
| K923509 | Randox Laboratories, Ltd. | GAMMA-GT | 1992-12-03 | 141 |
| K923091 | King Diagnostics, Inc. | KING DIAGNOSTICS GAMMA GT REAGENT | 1992-09-09 | 76 |
| K905618 | Amresco, Inc. | GGT REAGENT | 1991-02-26 | 74 |
Recalls for JPZ devices
openFDA lists no recalls for product code JPZ.
Frequently asked questions
What is FDA product code JPZ?
JPZ is the FDA product code for colorimetric method, gamma-glutamyl transpeptidase. It is a Class I device, regulated under 21 CFR 862.1360 and reviewed by the Clinical Chemistry panel.
What device class is JPZ?
Class I, regulation 21 CFR 862.1360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JPZ?
Across 33 cleared submissions the average was 51 days from receipt to decision (median 45).
Which companies have the most JPZ clearances?
Data Medical Associates, Inc. (3); Wako Chemicals USA, Inc. (2); Technostics Intl. (2); Harleco (2); Careside, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JPZ
- Run a recall and safety report across every JPZ manufacturer
- Watch product code JPZ 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