(21 days)
An in vitro diagnostic test for the qualitative identification of benzodiazepines in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse.
Immunoassay for the qualitative detection of benzodiazepines in Urine
Here's an analysis of the provided text to extract the requested information, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation | >99% correlation |
| Sensitivity | >99% |
| Specificity | >99% |
| Accuracy | >99% |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the numerical sample size for the test set. It refers to a "clinical sample correlation study" and a "blind labeled spiked study," implying real clinical specimens were used.
- Data Provenance: The "clinical sample correlation study" uses "clinical specimens," suggesting prospective or retrospective data from a clinical setting. The specific country of origin is not mentioned, but the manufacturer is based in San Diego, California, USA, implying U.S. clinical data. The "blind labeled spiked study" involves artificially prepared samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications used to establish the ground truth.
4. Adjudication method for the test set
The document does not describe any specific adjudication method. The ground truth for the clinical correlation study was established by comparison to two predicate devices (ABI SureStep and EMIT II Test).
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a rapid, qualitative immunoassay for the detection of benzodiazepines in urine and does not involve human readers interpreting images or data where AI assistance would be applicable in the traditional sense. The document states it exhibited "excellent sensitivity (>99%), specificity (>99%), and accuracy (>99%) in the hands of professional users," indicating human operation of the test, but not an MRMC study comparing human interpretation with and without AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is not an algorithm, but a qualitative immunoassay. Its performance is inherent in the test strip's chemical reaction and visual interpretation by "professional users." Therefore, a standalone algorithm performance study is not applicable. The performance described "in the hands of professional users" is essentially the device's standalone performance within its intended use.
7. The type of ground truth used
For the clinical sample correlation study, the ground truth was established by comparing the QuickScreen™ Benzodiazepines Screening Test results to two predicate devices:
- ABI SureStep (San Diego, CA 92121)
- EMIT II Test (San Jose, CA)
For the blind labeled spiked study, the ground truth would be based on the known concentrations of benzodiazepines in the spiked samples.
8. The sample size for the training set
The document does not mention a training set, as immunoassay devices typically do not involve machine learning models that require a distinct training phase.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set.
§ 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).