(135 days)
The Visualine®II (SunLine®) Barbiturates Test is used for qualitative testing for the presence of Secobarbital in urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.
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The provided text is a 510(k) premarket notification approval letter for the Visualine® II (SunLine®) Barbiturates Test. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance studies.
The letter indicates the device's intended use: "qualitative testing for the presence of Secobarbital in urine samples at or above 300 ng/ml." It also states that the test provides a preliminary screening result and recommends a more specific alternative method for confirmation.
To address your questions directly, information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies would typically be found in the 510(k) submission document itself or associated clinical study reports, which are not part of this approval letter.
Therefore, I cannot provide the requested table and study details based solely on the provided text. The document is an FDA approval letter, not the technical study data.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).