Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
The Software, Similarity Score Algorithm, Tissue of Origin for Malignant Tumor Types is an in vitro diagnostic software test service performed in a single laboratory that measures the degree of similarity between the RNA expression pattern in a patient's fresh-frozen tumor and a database of tumor samples from known malignant tumor types, intended to aid qualified clinicians in conjunction with clinical history and other diagnostic tests; it is not intended to establish the origin of tumors that cannot be diagnosed by current clinical and pathological practice. Classified as FDA Class 2 under regulation 21 CFR 862.3100 within the Clinical Toxicology medical specialty, it requires a 510(k) premarket notification and is eligible for third-party review. The product code is OIW. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OIW
- Device Class
- FDA class 2
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K173839 | Tissue of Origin Test Kit-FFPE | Mar 15, 2018 | Substantially Equivalent | Cancer Genetics, Inc. |
| K120489 | TISSUE OF ORIGIN TEST KIT FFPE | May 17, 2012 | Substantially Equivalent | Pathwork Diagnostics, Inc. |
| K092967 | PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE | Jun 08, 2010 | Substantially Equivalent | Pathwork Diagnostics |
| K080896 | PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST | Jul 30, 2008 | Unknown | Pathwork Diagnostics, Inc. |