FDA 510K for Opiate Test System
An Opiate Test System is a device that detects the presence of opiates in a urine, blood, saliva, or other sample. Opiates are addictive narcotic drugs that are used to treat pain
Intended Use of Opiate Test System
An Opiate Test System is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmacological actions. The opiates include drugs such as morphine, morphine glucuronide, heroin, codeine, nalorphine, and meperidine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Opiate Test System
FDA 510K for Opiate Test System Device Code and Regulation Number
Enzyme Immunoassay, Opiates
Intended Use:
The Opiate Test System is designed for rapid detection of drugs, hormones, and biomarkers in biological samples like urine or blood.
Device Description:
The Opiate Test System is a portable, easy-to-use diagnostic platform that utilizes enzyme immunoassay (EIA) technology for rapid detection of various substances, such as drugs, hormones, and biomarkers. It offers quick results (usually within 5-15 minutes) through a simple test format, often using cassette strips or cartridges. The system detects the target substance by using antibody-enzyme reactions, with results displayed as color changes or signals visible to the user. Ideal for point-of-care settings, it is used in clinics, emergency rooms, and home testing due to its simplicity, accuracy, and versatility in detecting multiple substances like drugs and hormones.
Test, Opiates, Over the Counter
Intended Use:
Tests are immunoassays designed for the qualitative detection of Fentanyl (FYL) and Nor fentanyl (NFYL) in human urine. These tests are available as single panels for either Fentanyl or Nor fentanyl, or as a dual panel for both substances. The cut-off levels for detection are 1 ng/mL for Fentanyl and 5 ng/mL for Nor fentanyl. These tests provide preliminary screening results only, and for a confirmed outcome, more specific methods like Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS) are recommended.
Device Description:
Test work on the principle of competitive binding. During testing, urine moves upward through the device by capillary action. If the drug concentration in the urine is below the cutoff level, the drug will not saturate the antibody-coated particles, allowing them to bind with the immobilized drug conjugate, resulting in a visible colored line at the test line region. If the drug level exceeds the cutoff, it will saturate all antibody binding sites, preventing the colored line from appearing. A control line will always appear to confirm proper test procedure and sample application.
Performance Testing (Analytical) for Opiate Test System
- Limit of Blank (LoB)/Limit of Detection (LoD)
- Limit of Quantitation (LoQ)
- Linearity/Recovery
- Precision
- Analytical specificity
- Analytical sensitivity
- Cross-Reactivity
- Interference
- Stability
- Method Comparison
Clinical Testing
Not Applicable for 510k submission