(149 days)
NicAlert™ is intended for in vitro diagnostic professional use for the semiquantitative determination of cotinine in urine for the purpose of determining if an individual has been exposed to tobacco products such as cigarettes, pipes, or chewing tobacco within the past 48 hours. The cutoff concentration for the NicAlert™ test is 100 ng/mL. Second hand smoke exposure (environmental tobacco smoke) may cause a positive result in a non-user of tobacco products. The NicAlert™ Positive and Negative Controls are intended for in vitro diagnostic use for the quality control of the NicAlert™ test.
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The provided text is a letter from the FDA regarding the clearance of the NicAlert™ device. It does not contain information about acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot fulfill your request based on the given input.
§ 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.