(105 days)
"Rapid Drug Screen" 8-Panel low volume test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel). "Rapid Drug Screen" 8-Panel low volume test is intended for use in the qualitative detection of the following 8 drugs of abuse in human urine at the following levels:
d-Amphetamine 750 ng/ml
Barbiturates 300 ng/ml
Benzodiazepines 300 ng/ml
Benzoyl ecognine 225 ng/ml
Cannabinoids (11-nor-9-carboxy-delta-9-THC) 50 ng/ml
Methamphetamine 1000 ng/ml
Opiates (codeine) 225 ng/ml
(morphine-3-glucuronide) 225 ng/ml
Phencyclidine (PCP) 19 ng/ml
"Rapid Drug Screen" 8-Panel low volume test is intended for use by professional laboratories and physicians offices in a clinical setting. The assays are easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary analytical test result for use in determining the need for additional or confirmatory testing (i.e., · gas chromatography/mass spectrometry (GC/MS)).
"Rapid Drug Screen" 8-Panel low volume test provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
"Rapid Drug Screen" 8-Panel low volume test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel).
I am sorry, but the provided text does not contain the detailed study information needed to answer your request regarding acceptance criteria and device performance. The document is an FDA 510(k) clearance letter for a device called "Rapid Drug Screen 8-Panel Low Volume II." It describes the device's indications for use and lists the cutoff concentrations for detectable substances but does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts.
- Information on adjudication methods, MRMC studies, or standalone performance.
- Details about the type of ground truth used or how ground truth was established for training sets.
Essentially, this document is a regulatory approval notice, not a scientific study report.
§ 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).