(335 days)
The Cozart Bioscience EIA Cotinine Urine Kit is intended for laboratory based testing in clinical and analytical laboratories and for insurance assessment. It provides qualitative screening results for Cotinine in human urine at a cut-off concentration of 500ng/ml. The Cozart EIA Cotinine Urine Kit acts as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine.
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 (GC/MS) is the preferred confirmatory method.
The Cozart EIA Cotinine Urine Kit test is a competitive ELISA for the detection of Cotinine in human urine. The kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 50, 500 and 5000ng/ml Cotinine in human urine).
Here's a breakdown of the acceptance criteria and the study details for the Cozart EIA Cotinine Urine Kit, based on the provided text:
Acceptance Criteria and Device Performance
| Parameter | Acceptance Criteria (Implied by Predicate/Performance Claims) | Reported Device Performance (Cozart EIA Cotinine Urine Kit) |
|---|---|---|
| Intended Use | Qualitative test for Cotinine in human urine with a 500ng/ml cutoff. Recommendation for GC/MS confirmation. | Qualitative test for Cotinine in human urine with a 500ng/ml cutoff. Recommendation for GC/MS confirmation. |
| Method Comparison | High agreement with GC/MS for positive and negative samples. | 98% agreement for positive results (56/57), 100% agreement for negative results (38/38) with GC/MS (based on 95 samples). |
| Precision | CV (%) for the assay should be acceptable for qualitative ELISA (e.g., |
§ 862.3220 Carbon monoxide test system.
(a)
Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.(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 the limitations in § 862.9.