TISSUE OF ORIGIN TEST KIT FFPE is an AI-enabled medical device from PATHWORK DIAGNOSTICS, INC. that the U.S. FDA cleared through 510(k) K120489 on May 17, 2012. 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).
Key facts
| Submission number | K120489 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | PATHWORK DIAGNOSTICS, INC. |
| Lead review panel | Clinical Toxcicology |
| Primary product code | OIW — Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
| Applicant (openFDA) | Pathwork Diagnostics, Inc. |
| Applicant location | Palo Alto, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 862.3100 |
| Decision code | SESE |
| Submission type | Traditional |
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 (K120489).
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 #3 of 4 under that code. PATHWORK DIAGNOSTICS, INC. has 2 AI-enabled devices 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.
Similar devices (product code OIW)
- Tissue of Origin Test Kit-FFPECancer Genetics, Inc. · Clinical Toxcicology
- PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPEPATHWORK DIAGNOSTICS · Clinical Toxcicology
- PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TESTPATHWORK DIAGNOSTICS, INC. · Clinical Toxcicology