Tissue of Origin Test Kit-FFPE is an AI-enabled medical device from Cancer Genetics, Inc. that the U.S. FDA cleared through 510(k) K173839 on March 15, 2018. Its lead review panel is Clinical Toxcicology and its primary product code is OIW (Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types).
See also all FDA AI clearances in 2018.
Key facts
| Submission number | K173839 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Cancer Genetics, Inc. |
| Lead review panel | Clinical Toxcicology |
| Primary product code | OIW — Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
| Applicant (openFDA) | Cancer Genetics, Inc. |
| Applicant location | Los Angeles, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 862.3100 |
| Decision code | SESE |
| Submission type | Special |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Tissue of Origin Test Kit-FFPE went through this pathway (K173839).
openFDA lists it as a Class 2 device under 21 CFR 862.3100. Class II devices are moderate risk and are subject to general and special controls.
Product code OIW covers 4 devices on the FDA AI list. By decision date, this device is #4 of 4 under that code. Cancer Genetics, Inc. has 1 AI-enabled device on the list, and the Clinical Toxcicology panel accounts for 5 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.