FDA product code PZM: Next Generation Sequencing Based Tumor Profiling Test
PZM is the FDA product code for next generation sequencing based tumor profiling test. It is a Class II device, regulated under 21 CFR 866.6080 and reviewed by the Pathology panel. FDA has cleared 7 510(k) submissions under PZM, 4 in the last five years, from 7 different applicants. The average 510(k) review took 336 days (median 267); 225 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing.
Classification
| Field | Value |
|---|---|
| Device name | Next Generation Sequencing Based Tumor Profiling Test |
| Device class | Class II |
| Regulation | 21 CFR 866.6080 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PZM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 240 |
| 2020 | 1 | 267 |
| 2021 | 1 | 334 |
| 2022 | 1 | 718 |
| 2025 | 2 | 344 |
| 2026 | 1 | 106 |
Compare with all 510(k) review times · Search every PZM clearance
Top PZM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Datar Cancer Genetics Private Limited | 1 | 2026-05-12 |
| Tempus AI, Inc. | 1 | 2025-09-19 |
| Geneseeq Technology, Inc. | 1 | 2025-08-29 |
| Act Genomics | 1 | 2022-12-23 |
| Nyu Langone Medical Center | 1 | 2021-07-14 |
2 more applicants have PZM clearances. See the full list in Caduvo.
Most recent PZM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260235 | Datar Cancer Genetics Private Limited | CellDx-Tissue | 2026-05-12 | 106 |
| K241868 | Tempus AI, Inc. | xR IVD | 2025-09-19 | 449 |
| K250003 | Geneseeq Technology, Inc. | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | 2025-08-29 | 239 |
| K210017 | Act Genomics | ACTOnco, ACTOnco IVD | 2022-12-23 | 718 |
| K202304 | Nyu Langone Medical Center | NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) | 2021-07-14 | 334 |
Recalls for PZM devices
openFDA lists no recalls for product code PZM.
Frequently asked questions
What is FDA product code PZM?
PZM is the FDA product code for next generation sequencing based tumor profiling test. It is a Class II device, regulated under 21 CFR 866.6080 and reviewed by the Pathology panel.
What device class is PZM?
Class II, regulation 21 CFR 866.6080. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZM?
Across 7 cleared submissions the average was 336 days from receipt to decision (median 267).
Which companies have the most PZM clearances?
Datar Cancer Genetics Private Limited (1); Tempus AI, Inc. (1); Geneseeq Technology, Inc. (1); Act Genomics (1); Nyu Langone Medical Center (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PZM
- Run a recall and safety report across every PZM manufacturer
- Watch product code PZM 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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