510(k) K173839
K173839 is an FDA 510(k) premarket notification submitted by Cancer Genetics, Inc. for the device "Tissue of Origin Test Kit-FFPE". The FDA issued a decision of Substantially Equivalent on March 15, 2018. The device falls under product code OIW (Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types), a Class II device regulated under 21 CFR 862.3100.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2018
- Date Received
- December 18, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type
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.