NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
FDA 510(k) K202304 · Nyu Langone Medical Center
510(k) numberK202304
Submission
- Device name
- NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
- Applicant
- Nyu Langone Medical Center
New York, NY, US - Received
- August 14, 2020
- Decision date
- July 14, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
Device classification
- Product code
- PZM – Next Generation Sequencing Based Tumor Profiling Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6080
- Specialty
- Pathology
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.
Other 510(k)s with product code PZM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260235 | CellDx-TissuePZM · Traditional | Datar Cancer Genetics Private Limited | 05/12/2026SE |
| K241868 | xR IVDPZM · Traditional | Tempus AI, Inc. | 09/19/2025SE |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)PZM · Traditional | Geneseeq Technology, Inc. | 08/29/2025SE |
| K210017 | ACTOnco, ACTOnco IVDPZM · Traditional | Act Genomics | 12/23/2022SE |
| K192063 | PGDx elio tissue completePZM · Traditional | Personal Genome Diagnostics | 04/24/2020SE |
| K190661 | Omics CorePZM · Traditional | Nanthealth, Inc. | 11/09/2019SE |
Questions and answers
When was NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) cleared by the FDA?
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) (K202304) received a 510(k) decision of Substantially Equivalent on July 14, 2021, 334 days after the submission was received.
What is the product code of K202304?
The FDA product code is PZM – Next Generation Sequencing Based Tumor Profiling Test, a Class II (moderate risk) device regulated under 21 CFR 866.6080.