(316 days)
One Step Multiple Drugs of Abuse Assays is used for the qualitative determination of the following drugs of abuse in urine: Amphetamine (amphetamine), Barbiturate (secobarbital), Benzodiazipines (oxazepam), Cocaine (benzoylecgonine), Methamphetamine (methamphetamine), Morphine (morphine), Opiate (morphine), Methadone (methadone), Methylenedioxymethamphetamine (methylenedioxymethamphetamine), Phencyclidine (phencyclidine), Tricyclic antidepressant drugs (nortriptyline), Cannabinoids (tetrahydrocannabinol-COOH). The configurations of the One Step Multiple Drugs of Abuse Assays are available in any combination of the above tests. These devices are intended to be used by healthcare professionals only. For in vitro diagnostic use. Measurements obtained by this device are used in the diagnosis and treatment of use or overdose of the drugs listed above. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
Immunochromatographic assay for drugs of abuse using a lateral flow, one step system for the qualitative detection of specific drugs in human urine. Each assay uses a monoclonal antibody-dye congugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.
The provided text describes a premarket notification for a medical device (Wondfo Biotech Co. Ltd. One Step Multiple Drugs of Abuse Assays) but does not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, or comparative effectiveness studies.
The document primarily focuses on:
- Identifying the device and its intended use.
- Listing product codes and classifications.
- Claiming substantial equivalence to a predicate device (ACON Laboratories, Inc. One Step Drug Screen Test Card, K020771).
- Describing fundamental technological characteristics (immunochromatographic assay).
- Providing the FDA's clearance letter for the 510(k) submission, confirming substantial equivalence (K050024).
- Stating the Indications for Use, including specific drug cutoffs.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported performance, sample sizes, expert details, or study types, as this information is not present in the provided text. The document is primarily a regulatory filing rather than a detailed performance study report.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).