(96 days)
Immunoassay for the qualitative detection of Tricyclic Immunoassay for the quarteline at cutoff 1000 ng/mL) in human urine to assist in screening of drug of abuse samples.
Not Found
This looks like a 510(k) clearance letter for the AccuSign® TCA device, which is an immunoassay for the qualitative detection of Tricyclic Antidepressants (TCA) in human urine. Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The letter from the FDA is a notification of substantial equivalence for marketing the device, not a detailed technical report of the device's performance or the studies conducted. It refers to a 510(k) submission (K981801) which would contain the study details, but the submission itself is not provided here.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text.
To answer your questions, I would need access to the actual 510(k) submission document (K981801) or a similar technical report that describes the device's performance characteristics and the clinical or analytical studies conducted.
§ 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).