Cleared Traditional

K120489 - TISSUE OF ORIGIN TEST KIT FFPE (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120489 · Pathwork Diagnostics, Inc. · Pathology device
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May 2012
Decision
90d
Days
Class 2
Risk

K120489 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 Pathwork Diagnostics, Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 17, 2012 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.3100 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pathwork Diagnostics, Inc. devices

Submission Details

510(k) Number K120489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2012
Decision Date May 17, 2012
Days to Decision 90 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 77d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.