(68 days)
The ACON One Step Drug Screen Test Card and ACON One Step Drug Screen Test Card with Integrated Cup are rapid chromatographic immunoassay devices for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and/or barbiturate in human urine. The test is calibrated using analytes with their respective cutoff concentrations listed in the following table.
| Test | Calibrator | Cut-off |
|---|---|---|
| Amphetamine (AMP) | D-Amphetamine | 1,000 ng/mL |
| Barbiturates (BAR) | Secobarbital | 300 ng/mL |
| Benzodiazepines (BZO) | Oxazepam | 300 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Methamphetamine (mAMP) | D-Methamphetamine | 1,000 ng/mL |
| Morphine (MOP 300 or OPI 300) | Morphine | 300 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Opiates (OPI 2000) | Morphine | 2,000 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Marijuana (THC) | 11-nor- $\Delta^9$ -THC-9 COOH | 50 ng/mL |
The configurations of the ACON One Step Multi-Drug Screen Test Card and ACON One Step Multi-Drug Screen Test Card with Integrated Cup come with any combination of the above listed drug analytes. They are intended for the healthcare professionals including professionals at point-of-care sites.
The ACON One Step Drug Screen Test card are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous screening of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and/or barbiturate in human urine.
The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibody to selectively detect elevated levels of Marijuana, Cocaine, Methamphetamine. Amphetamine. Opiates. Phencyclidine, Benzodiazepine, Methadone, and/or barbiturate in urine. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing the drug concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been applied and membrane wicking has occurred.
The provided text describes the ACON One Step Drug Screen Test Card, an immunochromatographic assay for the qualitative and simultaneous detection of various drugs in human urine. The information focuses on the device's intended use and classification but does not contain details about specific acceptance criteria or an analytical study proving that the device meets such criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or its data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or improvement with AI assistance.
- Information on a standalone algorithm performance study.
- The type of ground truth used (beyond implying chemical analysis based on calibrators).
- Sample size for the training set.
- How the ground truth for the training set was established.
The available text primarily serves as a 510(k) summary, detailing the device description, intended use, and regulatory classification for FDA clearance. The key information provided related to performance is the list of analytes and their respective cut-off concentrations, against which the test is calibrated. This implies that the device is intended to accurately detect these drugs at or above these specified cut-off levels.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).