FDA product code JZG: System, Test, Beta-2-Microglobulin Immunological
JZG is the FDA product code for system, test, beta-2-microglobulin immunological. It is a Class II device, regulated under 21 CFR 866.5630 and reviewed by the Immunology panel. FDA has cleared 53 510(k) submissions under JZG, from 32 different applicants. The average 510(k) review took 124 days (median 86). FDA has posted 6 recalls for JZG devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Beta-2-Microglobulin Immunological |
| Device class | Class II |
| Regulation | 21 CFR 866.5630 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JZG clearance
Top JZG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site, Ltd. | 6 | 2009-05-06 |
| Pharmacia, Inc. | 5 | 1990-08-17 |
| Behring Diagnostics, Inc. | 3 | 1996-10-03 |
| Diagnostic Products Corp. | 3 | 1993-09-24 |
| Diagnostic Systems Laboratories, Inc. | 3 | 1992-03-17 |
27 more applicants have JZG clearances. See the full list in Caduvo.
Most recent JZG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161297 | Beckman Coulter Ireland, Inc. | Beta-2-Microglobulin | 2016-06-07 | 29 |
| K122066 | The Binding Site Group , Ltd. | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | 2012-08-30 | 45 |
| K110874 | Siemens Healthcare Diagnostics, Inc. | ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR | 2012-01-20 | 297 |
| K083289 | The Binding Site, Ltd. | HUMAN BETA-2 MICROGLOBULIN KIT | 2009-05-06 | 180 |
| K083463 | Siemens Healthcare Diagnostics | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M | 2009-03-13 | 109 |
Recalls for JZG devices
6 product recalls in 6 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2024-10-21.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2021 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code JZG?
JZG is the FDA product code for system, test, beta-2-microglobulin immunological. It is a Class II device, regulated under 21 CFR 866.5630 and reviewed by the Immunology panel.
What device class is JZG?
Class II, regulation 21 CFR 866.5630. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZG?
Across 53 cleared submissions the average was 124 days from receipt to decision (median 86).
Which companies have the most JZG clearances?
The Binding Site, Ltd. (6); Pharmacia, Inc. (5); Behring Diagnostics, Inc. (3); Diagnostic Products Corp. (3); Diagnostic Systems Laboratories, Inc. (3).
Have JZG devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2024-10-21.
Next steps
- Run an FDA pathway report with predicate devices for product code JZG
- Run a recall and safety report across every JZG manufacturer
- Watch product code JZG 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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