Devices · PATHWORK DIAGNOSTICS

PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE

PATHWORK DIAGNOSTICS is listed for PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE (K092967). The FDA list gives June 8, 2010 as the date of the final decision. The lead panel is Clinical Toxcicology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OIW as “Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types”: This 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 for some common malignant tumor types that were diagnosed according to then current clinical and pathological practice. The test result is intended for use in the context of the patient?s clinical history and other diagnostic tests evaluated by a qualified clinician. The 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K092967

Official FDA database record

Date of final decision

June 8, 2010

Company on the FDA list

PATHWORK DIAGNOSTICS

Lead panel

Clinical Toxcicology

Primary product code

OIW

openFDA device name for the code

Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

Device class

2

Regulation number

862.3100

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary