PZJClass II
Lynch Syndrome Test System
21 CFR 864.1866 / Immunology
PZJ is the FDA product code for Lynch Syndrome Test System, a class II device type, regulated under 21 CFR 864.1866. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PZJ
- Device name
- Lynch Syndrome Test System
- FDA 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
- Regulation
- 21 CFR 864.1866
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code PZJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2021 | 1 |
| 2023 | 2 |
Applicants with the most clearances
Product code PZJ| Applicant | Clearances |
|---|---|
| Biocartis NV | 1 |
| Leica Biosystems Newcastle Ltd. | 1 |
| Promega Corporation | 1 |
| Ventana Medical Systems Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.