OIW — Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types Class II
FDA product code OIW covers "Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types", a Class II medical device regulated under 21 CFR 862.3100. Submissions are reviewed by the Clinical Toxicology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OIW
- Device Class
- Class II
- Regulation Number
- 862.3100
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K173839 | cancer genetics | Tissue of Origin Test Kit-FFPE | March 15, 2018 |
| K120489 | pathwork diagnostics | TISSUE OF ORIGIN TEST KIT FFPE | May 17, 2012 |
| K092967 | pathwork diagnostics | PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE | June 8, 2010 |
| K080896 | pathwork diagnostics | PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST | July 30, 2008 |