(64 days)
This in viro method is intended to quantitatively measure carbemant drug, in human serum or plasma (heparin) using Syva EMIT 2000 Assay on a Technicon Immuno-1 system. Measurements of carbamazzoine are used in the diagnosis and treatment of carbamazepine overdose and in monitoring serum levels of carbamazepine to ensure appropriate therapy.
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Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:
Acceptance Criteria and Device Performance Study
The provided document describes the "Carbamazepine Method for Bayer Technicon Immuno 1 System" and its comparison to a predicate device, the "Syva EMIT® 2000 Carbanazepine Assay."
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" but presents performance metrics for both the Immuno 1 Carbamazepine method and the predicate device, implying these are the performance characteristics against which the new device is being evaluated for substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied by Predicate Device Performance) | Immuno 1 Carbamazepine (Reported Device Performance) |
|---|---|---|
| Minimum Detectable Conc. |
§ 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.