Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
OIW is the FDA product code for Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types, a class II device type, regulated under 21 CFR 862.3100. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OIW
- Device name
- Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
- FDA 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.
- Regulation
- 21 CFR 862.3100
- Device class
- Class II
- Review panel
- Clinical Toxicology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code OIW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2018 | 1 |
Applicants with the most clearances
Product code OIW| Applicant | Clearances |
|---|---|
| Pathwork Diagnostics, Inc. | 3 |
| Cancer Genetics, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OIW.
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