FDA product code OIW: 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. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under OIW, from 3 different applicants. The average 510(k) review took 138 days (median 106).
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.
Classification
| Field | Value |
|---|---|
| Device name | Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
| Device class | Class II |
| Regulation | 21 CFR 862.3100 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OIW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 87 |
Top OIW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pathwork Diagnostics, Inc. | 2 | 2012-05-17 |
| Cancer Genetics, Inc. | 1 | 2018-03-15 |
| Pathwork Diagnostics | 1 | 2010-06-08 |
Most recent OIW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K173839 | Cancer Genetics, Inc. | Tissue of Origin Test Kit-FFPE | 2018-03-15 | 87 |
| K120489 | Pathwork Diagnostics, Inc. | TISSUE OF ORIGIN TEST KIT FFPE | 2012-05-17 | 90 |
| K092967 | Pathwork Diagnostics | PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE | 2010-06-08 | 256 |
| K080896 | Pathwork Diagnostics, Inc. | PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST | 2008-07-30 | 121 |
Recalls for OIW devices
openFDA lists no recalls for product code OIW.
Frequently asked questions
What is FDA product code OIW?
OIW is the FDA product code for software, similarity score algorithm, tissue of origin for malignant tumor types. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel.
What device class is OIW?
Class II, regulation 21 CFR 862.3100. Typical premarket route: 510(k).
How long does a 510(k) take for product code OIW?
Across 4 cleared submissions the average was 138 days from receipt to decision (median 106).
Which companies have the most OIW clearances?
Pathwork Diagnostics, Inc. (2); Cancer Genetics, Inc. (1); Pathwork Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OIW
- Run a recall and safety report across every OIW manufacturer
- Watch product code OIW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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