(20 days)
Immunoassay for the qualitative detection of benzodiazepines and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drug.
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The provided document is a 510(k) clearance letter from the FDA for a device called "AccuSign® BZO", an immunoassay for detecting benzodiazepines in human urine. This document confirms the device's substantial equivalence to a legally marketed predicate device and does not contain the detailed study information typically found in a clinical trial report or a submission summary. Therefore, based only on the provided text, a comprehensive answer to your request cannot be fully generated as much of the requested information (acceptance criteria, specific performance data, sample sizes, expert qualifications, etc.) is not present.
However, I can extract what little can be inferred from the document. The general nature of a 510(k) submission for an in vitro diagnostic device implies certain aspects.
Here's an assessment based on the provided text and general knowledge of 510(k) submissions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide specific acceptance criteria or reported device performance metrics such as sensitivity, specificity, accuracy, or limits of detection. The letter merely states that the FDA "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
Therefore, no table can be generated from this document.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not specify the number of experts used or their qualifications. For an immunoassay, the "ground truth" would typically be established by a reference method (e.g., GC/MS or LC/MS) rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method. For assays, the "adjudication" is typically a comparison to the reference method result.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
MRMC studies are typically for image-based diagnostic devices where human interpretation is involved. The AccuSign® BZO is an immunoassay for qualitative detection, which usually gives a discrete positive/negative result. Therefore, it is highly unlikely an MRMC study was conducted or would be relevant for this type of device. The document does not mention any MRMC study.
6. Standalone (Algorithm Only) Performance:
This device is an immunoassay, which provides a direct chemical or biological result rather than an algorithm processing data. Therefore, the concept of "standalone (algorithm only)" performance, as typically applied to AI/ML devices, is not applicable here. The device itself is "standalone" in that it provides a result without subsequent human interpretation for its primary function. The document does not explicitly state "standalone performance" in the context of an algorithm.
7. Type of Ground Truth Used:
While not explicitly stated, for an immunoassay detecting drugs of abuse, the ground truth would almost certainly be established by confirmatory analytical methods such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS). These methods are considered the gold standard for drug detection and quantification.
8. Sample Size for the Training Set:
The document is for a traditional immunoassay, not an AI/ML device. Therefore, the concept of a "training set" in the context of machine learning is not applicable here. Standard immunoassays are developed and validated through laboratory testing and do not typically involve a "training set" in the computational sense. The document does not specify any training set size.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a "training set" is not applicable to traditional immunoassays. Therefore, this question cannot be answered from the provided document. Validation of the assay's performance would have been against a recognized reference method (e.g., GC/MS or LC/MS).
§ 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).