(62 days)
This homogeneous tricyclics serum tox enzyme immunoassay is intended to be used for qualitative and semiquantitative determination of tricyclic antidepressants in serum, plasma or urine of patients suspected of drug overdose. A 300 ng/mL nortriptyline cutoff calibrator is used in this assay to differentiate a positive from a negative sample. Detection of the drug presence and its approximate concentration in serum, plasma or urine from patients suspected of drug overdose can assist the physician in diagnosis and determination of steps towards treatment.
homogeneous tricyclics serum tox enzyme immunoassay
This document is a 510(k) clearance letter from the FDA for a medical device called the "Tricyclic Serum Tox EIA Assay." This letter grants permission to market the device, indicating that it has been found substantially equivalent to a predicate device.
Unfortunately, the provided document {0}, {1}, and {2} does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on the regulatory clearance process and states the intended use of the device. It does not include a performance study report or any data related to method validation or clinical trials that would detail acceptance criteria and a study proving the device meets them.
Therefore, I cannot provide the requested information based on the provided text. To answer these questions, a separate document detailing the device's performance study, such as a summary of safety and effectiveness, would be needed.
§ 862.3910 Tricyclic antidepressant drugs test system.
(a)
Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.(b)
Classification. Class II (special controls). A tricyclic antidepressant drugs 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).