(42 days)
Wondfo Amphetamine Urine Test, Wondfo Secobarbital Urine Test, and Wondfo Oxazepam Urine Test are intended for the qualitative determination of Amphetamine, Secobarbital, Oxazepam at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use.
Wondfo Amphetamine Urine Test is an immunochromatographic assay for the qualitative determination of d-Amphetamine in human urine at a cutoff concentration of 1000ng/mL. The test is available in a cassette format and a strip format. It is intended for prescription use and over the counter use.
Wondfo Secobarbital Urine Test is an immunochromatographic assay for the qualitalive determination of Secobarbital (major metabolite of Barbiturates) in human urine at a cutoff concentration of 300ng/mL. The test is available in a cassette format and a strip format. It is intended for prescription use and over the counter use.
Wondfo Oxazepam Urine Test is an immunochromatographic assay for the qualitative determination of Oxazepam (major metabolite of Benzodiazepines) in human urine at a cutoff concentration of 300ng/mL. The test is available in a cassette format and a strip format. It is intended for prescription use and over the counter use.
Immunochromatograph assay for Amphetamine, Secobarbital, and Oxazepam Urine Test using a lateral flow, one step system for the qualitative detection of Amphetamine, Secobarbital, and Oxazepam in human urine. Each assay uses a monoclonal antibody-dve conjuqate from mouse aqainst drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.
The provided text describes three urine drug tests (Amphetamine, Secobarbital, and Oxazepam) but does not include any study data or acceptance criteria. The document is a 510(k) summary for a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device. It defines the intended use and compares technological characteristics with a predicate device, but there is no information about analytical or clinical performance studies with acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The closest information available is the intended use and cut-off values, which are listed in the "Comparison to the predicate device" table ({1}). However, these are specifications, not acceptance criteria for performance.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).