Product code OIW— Clinical Toxicology

“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.”

FDA has cleared 4 devices under product code OIW between 2008 and 2018, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20181 clearance
• 20121 clearance
• 20101 clearance
• 20081 clearance

• Pathwork Diagnostics, Inc.2 clearances
• Pathwork Diagnostics1 clearance
• Cancer Genetics, Inc.1 clearance

• K173839 — Tissue of Origin Test Kit-FFPECancer Genetics, Inc.·2018-03-15
• K120489 — TISSUE OF ORIGIN TEST KIT FFPEPathwork Diagnostics, Inc.·2012-05-17
• K092967 — PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPEPathwork Diagnostics·2010-06-08
• K080896 — PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TESTPathwork Diagnostics, Inc.·2008-07-30