FDA product code PZJ: Lynch Syndrome Test System
PZJ is the FDA product code for lynch syndrome test system. It is a Class II device, regulated under 21 CFR 864.1866 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under PZJ, 2 in the last five years, from 3 different applicants. The average 510(k) review took 577 days (median 552). 1 De Novo request was granted under it.
Definition
The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome
Classification
| Field | Value |
|---|---|
| Device name | Lynch Syndrome Test System |
| Device class | Class II |
| Regulation | 21 CFR 864.1866 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
510(k) clearances per year for PZJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 552 |
| 2023 | 2 | 590 |
Compare with all 510(k) review times · Search every PZJ clearance
Top PZJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biocartis NV | 1 | 2023-02-27 |
| Leica Biosystems Newcastle, Ltd. | 1 | 2023-02-21 |
| Promega Corporation | 1 | 2021-07-26 |
Most recent PZJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211181 | Biocartis NV | Idylla MSI Test | 2023-02-27 | 678 |
| K213348 | Leica Biosystems Newcastle, Ltd. | BOND MMR Antibody Panel | 2023-02-21 | 501 |
| K200129 | Promega Corporation | OncoMate MSI Dx Analysis System | 2021-07-26 | 552 |
Recalls for PZJ devices
openFDA lists no recalls for product code PZJ.
Frequently asked questions
What is FDA product code PZJ?
PZJ is the FDA product code for lynch syndrome test system. It is a Class II device, regulated under 21 CFR 864.1866 and reviewed by the Pathology panel.
What device class is PZJ?
Class II, regulation 21 CFR 864.1866. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZJ?
Across 3 cleared submissions the average was 577 days from receipt to decision (median 552).
Which companies have the most PZJ clearances?
Biocartis NV (1); Leica Biosystems Newcastle, Ltd. (1); Promega Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PZJ
- Run a recall and safety report across every PZJ manufacturer
- Watch product code PZJ 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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