(67 days)
Benzodiazepines Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
The Roche ONLINE DAT Benzodiazepines Plus assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml and 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. The assay is based on the kinetic interaction of microparticles in a solution (KIMS technology). Assay measurement is based on measurable changes in light transmission related to the interaction of microparticles in a solution and the sample drug of interest. if present. Benzodiazepine drug derivative is conjugated to microparticles in solution, and benzodiazepine polyclonal antibody (sheep) is solubilized in buffer. In the absence of sample drug, free antibody binds to drug-microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When a urine sample contains the drug in question, this drug competes with the particle-bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. 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.
The provided text describes a 510(k) summary for the Roche ONLINE DAT Benzodiazepines Plus assay, an in vitro diagnostic test for detecting benzodiazepines in human urine. However, it does not contain the detailed study information, acceptance criteria, or performance data that would allow for a complete answer to your request.
Specifically, the document focuses on regulatory approval and equivalence to a predicate device, rather than a detailed performance study with explicit acceptance criteria and corresponding results.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
What can be gathered from the provided text:
- Device Name: ONLINE DAT Benzodiazepines Plus
- Intended Use: Qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml, and 300 ng/ml. Semi-quantitative results allow assessment of assay performance as part of a quality control program.
- Predicate Device: Abuscreen OnLine Benzodiazepines assay (K983702).
- Technology: Kinetic interaction of microparticles in a solution (KIMS technology).
- Differences from Predicate (Improvements):
- Change in accelerant/activator in the diluent solution for the antibody working solution.
- Change in polyclonal antibody purification (from non-specific IgG binding to immunoaffinity purification).
- Improved precision.
- Use of new (previously cleared) calibrators and unassayed controls.
- Regulatory Status: Substantially equivalent to the predicate device, allowing it to be marketed.
Missing Information (and why it's missing from this document):
The 510(k) summary provided is a high-level overview for regulatory filing. It emphasizes substantial equivalence to a previously cleared device. A full study report, which would typically contain the detailed performance data, acceptance criteria, sample sizes, and ground truth methodologies, is not included in this summary. Such details would be found in the manufacturer's internal validation studies, not necessarily in the public-facing 510(k) summary.
In conclusion, while the document explains the device's purpose and its regulatory pathway, it does not offer the specific data points required to fill out the table and answer the detailed questions about acceptance criteria and study particulars.
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).