(35 days)
Immunoassay for the qualitative detection of Barbiturates, Benzodiazephines 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 drugs.
Not Found
The provided documents do not contain the specific details about acceptance criteria or a study proving the device meets those criteria, as typically found in a detailed submission for device clearance. This document is an FDA clearance letter for the AccuSign™ DOA 2(BAR/BZO) device, indicating that the FDA has determined it is "substantially equivalent" to previously marketed devices.
Therefore, I cannot provide information for most of your requested points. However, I can extract what is available:
1. A table of acceptance criteria and the reported device performance:
- Not found in the provided text. The letter simply states the device is "substantially equivalent." Substantial equivalence is a regulatory standard, not a performance metric defined by specific acceptance criteria within this document.
2. Sample size used for the test set and the data provenance:
- Not found in the provided text. This information would typically be in the 510(k) submission itself, not the clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not found in the provided text.
4. Adjudication method for the test set:
- Not found in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable and not found in the provided text. This device is an immunoassay for drug detection, not an AI-assisted diagnostic tool read by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the AI sense. This device is a qualitative immunoassay. The performance would be inherent to the test itself; there's no "algorithm only" performance separate from the human interpreting the test result (e.g., presence or absence of a line). Standalone performance in this context would refer to the device's accuracy in detecting the target substances. However, specific performance metrics (sensitivity, specificity, etc.) are not found in the provided text.
7. The type of ground truth used:
- Not found in the provided text. For an immunoassay, the ground truth would typically be established by a more definitive laboratory method (e.g., GC/MS for drug detection).
8. The sample size for the training set:
- Not applicable and not found in the provided text. This is not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established:
- Not applicable and not found in the provided text.
Summary based on the provided FDA clearance letter:
The letter confirms the FDA has reviewed K974181 AccuSign™ DOA 2(BAR/BZO) and determined it is substantially equivalent to legally marketed predicate devices for the qualitative detection of Barbiturates, Benzodiazepines and/or their metabolites in human urine. The "Indications For Use" state it is "to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs."
To get the detailed information you are requesting about performance criteria, study design, and data, you would typically need to review the full 510(k) submission (which is publicly available, but not included in these documents) for K974181.
§ 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).