PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST is an AI-enabled medical device from PATHWORK DIAGNOSTICS, INC. that the U.S. FDA cleared through 510(k) K080896 on July 30, 2008. 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 | K080896 |
|---|---|
| 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 | Sunnyvale, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 862.3100 |
| Decision code | SESU |
| 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. PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST went through this pathway (K080896).
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 #1 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.
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