Clinical Toxcicology · 510(k) · 2012
TISSUE OF ORIGIN TEST KIT FFPE
PATHWORK DIAGNOSTICS, INC.. Cleared by FDA on 17 May 2012 under submission K120489, product code OIW (software, similarity score algorithm, tissue of origin for malignant tumor types). What FDA's record says, in FDA's words.
Device record · K120489
- Device. TISSUE OF ORIGIN TEST KIT FFPEDEVICE
- Company. PATHWORK DIAGNOSTICS, INC.COMPANY
- Decision. 17 May 2012, 510(k), substantially equivalent (traditional review); received 17 February 2012DECISION
- Panel. Clinical ToxcicologyPANEL
- Product code. OIW, Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor TypesCODE
- Regulation. 21 CFR 862.3100, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Pathwork Tissue of Origin Test is an in vitro diagnostic intended to measure the degree of similarity between the RNA expression patterns in a patient's formalin-fixed, paraff in-em bedded (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.
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code OIW. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OIW, in Clinical Toxcicology, from PATHWORK DIAGNOSTICS, INC., or cleared in 2012. The whole record is at FDA AI-enabled medical devices.
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