Cleared Special

K173839 - Tissue of Origin Test Kit-FFPE (FDA 510(k) Clearance)

Class II Pathology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K173839 · Cancer Genetics, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
87d
Days
Class 2
Risk

K173839 is an FDA 510(k) clearance for the Tissue of Origin Test Kit-FFPE. Classified as Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types (product code OIW), Class II - Special Controls.

Submitted by Cancer Genetics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on March 15, 2018 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.3100 - the FDA pathology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cancer Genetics, Inc. devices

Submission Details

510(k) Number K173839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2017
Decision Date March 15, 2018
Days to Decision 87 days
Submission Type Special
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 77d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OIW Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.