OIW

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

Device class

Class II (moderate risk)

Regulation

21 CFR 862.3100

Medical specialty

Clinical Toxicology

Flags

Third-party review eligible

FDA definition

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.

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