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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device software, similarity score algorithm, tissue of origin for malignant tumor types
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.
Product CodeOIW
Regulation Number 862.3100
Device Class 2

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