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U.S. Department of Health and Human Services

Product Classification

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Device setmelanotide eligibility gene variant detection system
Definition A setmelanotide eligibility gene variant detection system is a qualitative in vitro diagnostic device intended to detect germline variants within genes isolated from human specimens for the purpose of identifying patients with obesity who may benefit from treatment with setmelanotide in accordance with the approved therapeutic product labeling.
Physical State In vitro diagnostic germline variant detection system
Technical Method Qualitative in vitro diagnostic device that uses sequencing technology to detect germline variants in DNA from human clinical specimens
Target Area Human clinical specimens
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQRV
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1164
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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