4 devices · 3 companies · 2008 to 2018
Product code OIW: Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
4 devices under product code OIW, 2008 to 2018, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 4 here), the regulation, and MAUDE report counts by product code.
Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types. 21 CFR 862.3100, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Tissue of Origin Test Kit-FFPEK173839 · 510(k) | Cancer Genetics, Inc. | Clinical Toxcicology | database entry | |
| TISSUE OF ORIGIN TEST KIT FFPEK120489 · 510(k) | PATHWORK DIAGNOSTICS, INC. | Clinical Toxcicology | database entry | |
| PATHWORK TISSUE OF ORIGIN TEST KIT-FFPEK092967 · 510(k) | PATHWORK DIAGNOSTICS | Clinical Toxcicology | database entry | |
| PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TESTK080896 · 510(k) | PATHWORK DIAGNOSTICS, INC. | Clinical Toxcicology | database entry |
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