(139 days)
A rapid, competitive binding immunoassay for qualitative determination of morphine in urine.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "One Step Morphine Card Test." It serves as an official notification that the device has been found substantially equivalent to devices marketed prior to May 28, 1976, and can therefore be legally marketed.
However, the provided text does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications. This letter primarily focuses on the regulatory clearance for marketing the device.
To answer your questions, I would need to review the actual 510(k) submission document (which is typically a much larger and more detailed technical document submitted by the manufacturer to the FDA), or a public summary of it, if available.
Therefore, based solely on the provided text, I cannot provide the requested information. The document is a regulatory approval letter, not a scientific study report.
§ 862.3640 Morphine test system.
(a)
Identification. A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.(b)
Classification. Class II (special controls). A morphine 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).