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U.S. Department of Health and Human Services

Product Classification
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Device software, similarity score algorithm, tissue of origin for malignant tumor types
Regulation Description Amphetamine test system.
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.
Physical State Gene expression systems, which include either microarray systems or reverse-transcriptase polymerase chain reaction (RT-PCR) systems. Steps for microarray systems include RNA isolation kits, cDNA synthesis kits, in vitro transcription kits, hybridization, washing and staining systems, scanner, and computer
Technical Method Uses Gene expression and computer algorithm that estimate degree of similarity between analyzed specimen and examples of various tumor types comprising a database. Gene expression involves isolation of RNA from frozen tumor tissue sections, amplification of RNA and hybridization, and comparison of hybridization patterns.
Target Area Fresh frozen tumor tissue sections
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeOIW
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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