# K080896: Pathwork Diagnostics Tissue of Origin Test

- Pathway: 510(k) (Traditional)
- Applicant: Pathwork Diagnostics, Inc.
- Decided: Jul 30, 2008 after 121 days
- Product code: OIW (Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941596 (1995). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043341: Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System, Bio-Rad Laboratories, Inc. (2005) Summary page 1.

## Most influential descendants
- K092967: Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-Ffpe (2010), 2 descendants of its own
- K120489: Tissue of Origin Test Kit Ffpe (2012), 1 descendant of its own
- K173839: Tissue of Origin Test Kit-FFPE (2018), 0 descendants of its own

## Indications for use
The Pathwork® Tissue of Origin 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 (poorly differentiated, undifferentiated and metastatic cases) that were diagnosed according to then current clinical and pathological practice. The database contains examples of RNA expression patterns for fifteen common malignant tumor types: bladder, breast, colorectal, gastric, hepatocellular, kidney, non-small cell lung, ovarian, pancreatic, prostate and thyroid cancinominas, melanoma, testicular germ cell tumor, non-Hodgkins lymphoma (not otherwise specified), and soft tissue sarcoma (not otherwise specified). The Pathwork® Tissue of Origin Test result is intended for use in the context of the patient's clinical history and other diagnostic tests evaluated by a qualified clinician. Limitations: The Pathwork® Tissue of Origin 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. It is not intended to subclassify or modify the classification of tumors that can be diagnosed by current clinical and pathological practice, nor to predict disease course or survival or treatment efficacy, not to distinguish primary from metastatic tumor. Tumor types not in the Pathwork® Tissue of Origin Test database may have RNA expression patterns that are similar to patterns in the database.

Source page: https://510kreport.com/device/K080896
Methodology: https://510kreport.com/methodology