(135 days)
dBest MultiDrug Screen Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml, cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml, methamphetamines and its metabolites such as oxidized, deaminated derivatives in urine with cutoff of 1000 ng/ml, opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml and tetrahydrocannabinol and its metabolites 11-nor- 9tetrahydrocannabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest MultiDrug Screen Test Kits are for professional and laboratory use only.
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The provided document is a 510(k) clearance letter for the "dBest MultiDrug Screen Test Kit." This type of document declares substantial equivalence to a predicate device and does not typically include detailed acceptance criteria or a comprehensive study plan with the specific performance metrics you're requesting for a device like a diagnostic AI or imaging system.
The acceptance criteria and performance reported in this document are framed within the context of a drug screen test kit, which focuses on cut-off levels and qualitative detection.
Here's an attempt to answer your questions based on the limited information available in this 510(k) letter, interpreting the information in a way that aligns with your request where possible, and noting when the information is not present.
The dBest MultiDrug Screen Test Kit is a qualitative immunochromatographic assay for the rapid detection of specific drugs in urine.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Drug Tested | Acceptance Criteria (Cutoff) | Reported Device Performance (Qualitative Detection) |
|---|---|---|
| Amphetamines | 1000 ng/ml | Qualitative detection in urine |
| Cocaine (Benzoylecgonine) | 300 ng/ml | Qualitative detection in urine |
| Methamphetamines | 1000 ng/ml | Qualitative detection in urine |
| Opiates | 300 ng/ml | Qualitative detection in urine |
| Tetrahydrocannabinol | 50 ng/ml | Qualitative detection in urine |
| Overall | Not specified for accuracy | Substantially equivalent to predicate devices |
Note: The document lists the cutoff levels which serve as a form of acceptance criteria for a qualitative drug test. It doesn't report specific sensitivity, specificity, or accuracy percentages, as these would typically be detailed in the study report submitted to the FDA, not necessarily in the clearance letter itself.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in this document.
- Data Provenance: Not specified in this document. Typically, drug screen test kits would involve clinical samples from human subjects. The document does not indicate retrospective or prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For a qualitative drug test, ground truth is typically established by definitive analytical methods (e.g., GC/MS) rather than expert consensus on interpretation of the device's results.
4. Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods are more commonly used in interpreting subjective findings (e.g., medical images) rather than the binary (positive/negative) output of a qualitative drug screen.
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. This device is a rapid diagnostic test kit, not an AI-powered diagnostic imaging or interpretation system. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone test kit; it performs the detection without human interpretation beyond reading the visual result (e.g., line appearance). However, this question typically refers to AI algorithms. In that context, it's not applicable.
7. The type of ground truth used:
- While not explicitly stated in this document, for drug screen tests, the ground truth for establishing performance is typically definitive analytical methods (e.g., Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS)) to confirm the presence and concentration of the drug metabolites in the urine samples.
8. The sample size for the training set:
- Not applicable or not specified. Immunochromatographic assays do not typically involve a "training set" in the machine learning sense. The device's performance is based on its chemical and biological design.
9. How the ground truth for the training set was established:
- Not applicable. (See #8).
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).