(63 days)
An in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 ng/mL. Semi- quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
The Abuscreen OnLine Opiates 300/2000 assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 ng/mL. The assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drug-polymer conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. When a urine sample containing the drug in question is present, this drug competes with the drug conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, the presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
This 510(k) summary (K013482) describes the Roche Diagnostics Abuscreen OnLine Opiates 300/2000 assay, an in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine. The submission asserts substantial equivalence to a predicate device (K974840).
The provided text does not contain the detailed acceptance criteria or the study data proving the device meets those criteria. The document is a 510(k) summary and the FDA's clearance letter, which focus on the device's description, intended use, and comparison to a predicate device (Abuscreen OnLine II Opiates 300/2000 assay).
The 510(k) summary states that the assay utilizes the same reagent formulation as the predicate device and highlights the differences as the addition of a 300 ng/mL semi-quantitative cutoff claim and application to Hitachi 900 series and Modular series analyzers. This implies that the performance characteristics of the new device are expected to be very similar to the predicate, but specific performance data or acceptance criteria for this particular submission are not included in the provided document.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based solely on the provided text.
To answer your questions regarding acceptance criteria and study details, more comprehensive information from the actual 510(k) submission, including performance study reports, would be required. The document provided is a high-level summary and regulatory correspondence, not the detailed technical data.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).