(30 days)
For in vitro diagnostic use only. VITROS CRBM slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma.
VITROS Chemistry Products CRBM Slides
This is a 510(k) clearance letter from the FDA for a medical device called "VITROS Chemistry Products CRBM Slides." This document does not contain the acceptance criteria or a study proving the device meets those criteria.
A 510(k) clearance is based on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily on a full clinical trial meeting predefined acceptance criteria in the same way a PMA (Premarket Approval) might require. The letter itself confirms the device is substantially equivalent and can be marketed, but does not detail the specific performance metrics or studies used to achieve that determination.
Therefore, I cannot fulfill your request for the detailed information as the provided text pertains to regulatory clearance rather than a scientific study report with acceptance criteria.
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.