FDA product code JQB: Kinetic Method, Gamma-Glutamyl Transpeptidase
JQB is the FDA product code for kinetic 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 52 510(k) submissions under JQB, from 33 different applicants. The average 510(k) review took 56 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Kinetic 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 JQB clearance
Top JQB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 10 | 1993-12-16 |
| Emd Chemicals, Inc. | 3 | 1983-02-28 |
| Diagnostic Chemicals , Ltd. | 2 | 1997-11-04 |
| Pointe Scientific, Inc., | 2 | 1997-10-10 |
| Roche Diagnostic Systems, Inc. | 2 | 1997-01-13 |
28 more applicants have JQB clearances. See the full list in Caduvo.
Most recent JQB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974000 | Diagnostic Chemicals , Ltd. | Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 | 1997-11-04 | 14 |
| K973157 | Pointe Scientific, Inc., | LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET | 1997-10-10 | 49 |
| K971466 | Carolina Liquid Chemistries Corp. | SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) | 1997-05-06 | 14 |
| K964457 | Roche Diagnostic Systems, Inc. | ROCHE COBAS IBTEGRA REAGENT CASSETTES | 1997-01-13 | 68 |
| K964916 | Derma Media Lab., Inc. | GAMMA-GLUTAMYL TRANSPEPTIDASE | 1997-01-10 | 32 |
Recalls for JQB devices
openFDA lists no recalls for product code JQB.
Frequently asked questions
What is FDA product code JQB?
JQB is the FDA product code for kinetic 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 JQB?
Class I, regulation 21 CFR 862.1360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQB?
Across 52 cleared submissions the average was 56 days from receipt to decision (median 35).
Which companies have the most JQB clearances?
Em Diagnostic Systems, Inc. (10); Emd Chemicals, Inc. (3); Diagnostic Chemicals , Ltd. (2); Pointe Scientific, Inc., (2); Roche Diagnostic Systems, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code JQB
- Run a recall and safety report across every JQB manufacturer
- Watch product code JQB 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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