# K120489: Tissue of Origin Test Kit Ffpe

- Pathway: 510(k) (Traditional)
- Applicant: Pathwork Diagnostics, Inc.
- Decided: May 17, 2012 after 90 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: 4 generations back to K941596 (1995). 4 ancestors in all.
1 later device descends 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)
- K092967: Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-Ffpe, Pathwork Diagnostics (2010) Summary page 1.

## Most influential descendants
- K173839: Tissue of Origin Test Kit-FFPE (2018), 0 descendants of its own

## Indications for use
The Pathwork® Tissue of Origin Test is an invitro diagnostic intended to measure the degree of similarity between the RNA expression patterns in a patient's formalin-fixed, paraffin-embedded (FFPE) tumor and the RNA expression patterns in a database of fifteen tumor types (poorly differentiated, undifferentiated and metastatic cases) that were diagnosed according to then current clinical and pathological practice. This test should be evaluated by a qualified physician in the context of the patient's clinical history and other diagnostic test results. Limitations: The Pathwork® Tissue of Origin Test is not intended to establish the origin of tumors (e.g. cancer 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, nor 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; therefore, results cannot be used to distinguish tumor types in the database from tumor types not in the database.

Source page: https://510kreport.com/device/K120489
Methodology: https://510kreport.com/methodology