OIW

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

Product code

OIW

Device name

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

Device class

Class 2

21 CFR

21 CFR 862.3100

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).