Clinical Toxcicology · 510(k) · 2008
PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
PATHWORK DIAGNOSTICS, INC.. Cleared by FDA on 30 July 2008 under submission K080896, 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 · K080896
- Device. PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TESTDEVICE
- Company. PATHWORK DIAGNOSTICS, INC.COMPANY
- Decision. 30 July 2008, 510(k), unknown (traditional review); received 31 March 2008DECISION
- 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 entrySOURCE
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 could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
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.
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 2008. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.