(16 days)
Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressans, methadone, and amphetamine in human urine to assist in the screening of drugs of abuse samples. The detection cut-off concentrations are as follows:
| MET | d-Methamphetamine | 1000 ng/mL |
|---|---|---|
| OPI | Morphine | 300 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| THC | 11-nor-A9-9-carboxylic acid | 50 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
| Benzodiazepine | Oxazepam | 300 ng/mL |
| Barbiturate | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| TCA | Nortriptyline | 1000 ng/mL |
| Amphetamine | d-Amphetamine | 1000 ng/mL |
Not Found
This document is a 510(k) clearance letter from the FDA for a qualitative immunoassay device, the AccuSign® DOA 10, for the detection of various drugs of abuse in human urine. It does not contain detailed information on the acceptance criteria and study results in the format requested.
The provided text only includes:
- The trade name and regulatory class of the device.
- The product codes and indications for use.
- The detection cut-off concentrations for each drug.
- A confirmation of substantial equivalence to predicate devices.
Therefore, I cannot provide the structured information about acceptance criteria and study details based on the given document. The document is essentially a clearance letter, not a detailed study report.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).