(147 days)
For in vitro diagnostic point-of-care prescription use. The LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate is a professional use singledrug test for the rapid determination of Opiate in human saliva. It provides qualitative screening results for Opiate at a cut-off value of 40 ng/mL. The disposable STM is used exclusively with the LifePoint IMPACT Test System instrument.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
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The provided text is a 510(k) clearance letter from the FDA for the "IMPACT Test System; Saliva Test Module- Opiate." It grants market clearance based on substantial equivalence to a predicate device. However, it does not include the detailed study or performance data that would typically contain acceptance criteria, sample sizes, ground truth establishment, or expert information as requested in your prompt.
Specifically, the document focuses on:
- Confirming the device name and regulation details.
- Stating that the device is substantially equivalent to a legally marketed predicate device.
- Outlining regulatory requirements and responsibilities for the manufacturer.
- Providing an "Indications For Use Statement" which describes what the device is intended for (in-vitro diagnostic, rapid determination of Opiate in human saliva at a cut-off of 40 ng/mL, professional/prescription use). It also mentions that the assay provides only a preliminary result and requires confirmation by more specific methods like GC/MS for a confirmed analytical result.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on the text provided. This information would typically be found in the 510(k) submission document itself, which is a much more extensive technical dossier than the FDA clearance letter.
§ 862.3650 Opiate test system.
(a)
Identification. 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 pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. 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.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).