(188 days)
The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is intended for use in clinical and forensic laboratories when used in conjunction with the Cozart® RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for amphetamines in human oral fluid at a cutoff concentration of 15ng/ml. This is equal to 45ng/ml in neat oral fluid as the collection system involves a 1:3 dilution of the sample.
This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GCMS) is the preferred confirmatory method.
The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is a laboratory based test for the detection of amphetamines in human oral fluid using a cutoff equivalent to 45ng/mL. The device detailed above was compared to Gas Chromatography/Mass Spectrometry (GC/MS).
As can be seen from the Principle of the Test section in the pack insert, the Cozart® EIA Amphetamines Oral Fluid Microplate Kit is a competitive ELISA for the detection of amphetamines in human oral fluid.
The Cozart® EIA Amphetamines Oral Fluid Microplate kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 2, 15 and 50ng/ml amphetamine in oral fluid matrix).
Here's an analysis of the provided text, outlining the acceptance criteria and the study data, as requested:
Acceptance Criteria and Device Performance Study for Cozart® EIA Amphetamines Oral Fluid Microplate Kit
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct thresholds in the provided document. Instead, the document presents comparison data against a "gold standard" (GC/MS) and a predicate device. Based on the performance reported, an implicit acceptance criterion can be inferred as achieving a high agreement with GC/MS. The precision (CV%) is explicitly stated as acceptable if below 10%.
| Parameter | Acceptance Criteria (Inferred/Explicit) | Reported Device Performance (Cozart® EIA Amphetamines Oral Fluid Microplate Kit) |
|---|---|---|
| Overall Agreement with GC/MS | High agreement with GC/MS (e.g., comparable to or better than predicate) | 96% |
| Precision (CV%) |
§ 880.5420 Pressure infusor for an I.V. bag.
(a)
Identification. A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.