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U.S. Department of Health and Human Services

Product Classification

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Device test, propoxyphene, over the counter
Regulation Description Propoxyphene test system.
Definition The propoxyphene test is an in vitro diagnostic test for the qualitative detection of propoxyphene in human urine. The test is intended for over-the-counter use as the first step in a two step process to provide consumers with information concerning the presence or absence of propoxyphene in a urine sample.
Physical State In vitro diagnostic device
Technical Method Immunoassay
Target Area Urine
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeQBF
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons