Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
OIW · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3100
Classification
FDA Product Code
OIW
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.3100
Review panel
TX
Medical specialty
Clinical Toxicology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.