(57 days)
The cassette COBAS Integra Serum Benzodiazepines contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of Benzodiazepines and their metabolites in human serum, heparinized plasma or urine. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of benzodiazepine use or overdose.
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This is an FDA 510(k) clearance letter for an in vitro diagnostic device, not a study report for an AI/ML device. Therefore, the requested information about acceptance criteria, study design, and performance metrics for AI/ML devices cannot be extracted from this document.
The document indicates that the device, "Roche COBAS INTEGRA Serum Benzodiazepines (SBENZ)," is deemed "substantially equivalent" to legally marketed predicate devices, which is the regulatory standard for 510(k) clearance. This means the device performs at least as well as existing, approved devices for the stated indications for use.
Here's what can be gathered from the provided text, but it does not align with the requested format for AI/ML device studies:
- Device Name: Roche COBAS INTEGRA Serum Benzodiazepines
- Intended Use: Detection of Benzodiazepines and their metabolites in human serum, heparinized plasma, or urine on the COBAS INTEGRA analyzer for toxicological screenings where the analytical result is used in the management of benzodiazepine use or overdose.
- Regulatory Class: II
- Product Code: JXM
- FDA Decision: Substantially Equivalent to predicate devices.
To answer your specific questions in the context of an AI/ML device, the provided text does not contain:
- A table of acceptance criteria and reported device performance: This document does not describe specific performance metrics (e.g., sensitivity, specificity, accuracy) or their acceptance thresholds.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish ground truth and their qualifications: Not applicable for a traditional in vitro diagnostic device regulatory submission of this type.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study or effect size: Not applicable. This is not an AI/ML device, and no human-in-the-loop study is described.
- Standalone performance (algorithm only): Not applicable for this type of device.
- Type of ground truth used: Not explicitly stated, but for a benzodiazepine detection assay, the ground truth would typically come from a reference method (e.g., GC-MS or LC-MS) of known accuracy.
- Sample size for the training set: Not applicable, as this is a chemical assay, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory clearance letter for a traditional in vitro diagnostic device, not a study report for an AI/ML-driven medical device. Therefore, the information requested regarding AI/ML device acceptance criteria and study details is not present.
§ 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).