Clinical_toxicology
TISSUE OF ORIGIN TEST KIT FFPE
PATHWORK DIAGNOSTICS, INC.
This test is intended to measure the degree of similarity between the RNA expression pattern in a patient's fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some common malignant tumor types that were diagnosed according to then current clinical and pathological practice. The test result is intended for use in the context of the patient's clinical history and other diagnostic tests evaluated by a qualified clinician. The test is not intended to establish the origin of tumors (e.g. carcinoma of unknown primary) that cannot be diagnosed according to current clinical and pathological practice.
FDA Submission Metadata
- Submission number
- K120489
- Decision date
- May 2012
- FDA panel
- Clinical Tcxicology
- Product code
- OIW
- Clinical task (npj)
- diagnosis
- Data modality (npj)
- Omics
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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