510(k) K120489
K120489 is an FDA 510(k) premarket notification submitted by Pathwork Diagnostics, Inc. for the device "TISSUE OF ORIGIN TEST KIT FFPE". The FDA issued a decision of Substantially Equivalent on May 17, 2012. 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. Pathwork Diagnostics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2012
- Date Received
- February 17, 2012
- Clearance Type
- Traditional
- 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.