(20 days)
Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines, barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.
Not Found
This FDA 510(k) clearance letter does not contain the detailed study information needed to fully answer your request. This document is a regulatory communication indicating that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It does not typically include the specifics of the performance studies themselves, such as acceptance criteria, sample sizes, ground truth establishment, or expert qualifications.
The letter explicitly mentions:
- Device Name: AccuSign® DOA8 (THC/OPI/COC/AMP/BZO/BAR/TCA/PCP)
- Indications for Use: Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines, barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples. This device is for "Professional Use" and "Prescription Use."
To describe the acceptance criteria and the study that proves the device meets them, I would need access to the actual 510(k) submission document or a summary of its contents, which would detail the performance data.
From the provided text, I can only state that a substantial equivalence determination was made based on the provided information, implying that the device’s performance was deemed comparable to legally marketed predicate devices.
Therefore, I cannot fill out the requested table or provide specific details about the study, sample sizes, expert qualifications, or ground truth establishment based solely on the text provided. The document is a clearance letter, not a study report.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).