(116 days)
The Redi-Test Cocaine is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of the cocaine metabolite, benzoylecgonine at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
The Redi-Test Cocaine is an immunochromatograpic based one step in vitro test.
Here's a summary of the acceptance criteria and the study details for the Redi-Test Cocaine device, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with predicate device (DRI Cocaine Enzyme Immunoassay) | 99% correlation |
| Detection of benzoylecgonine at a cutoff of 300ng/mL | The Redi-Test Cocaine detects benzoylecgonine at a cutoff concentration of 300ng/mL |
| Performance similar to predicate device in terms of sensitivity, specificity, accuracy, and precision. | The tests (Redi-Test Cocaine and DRI Cocaine Enzyme Immunoassay) are similar in sensitivity, specificity, accuracy, and precision. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 100 specimens (50 negative, 50 positive over the entire assay range).
- Data Provenance: Not explicitly stated, but implies collected specimens for comparison in a single study. No country of origin is mentioned, nor is it explicitly stated as retrospective or prospective. However, given the nature of a 510(k) submission for a new device, it is likely a prospective comparison study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The "ground truth" seems to be established by the predicate device's results and confirmed by an alternate methodology (GC/MS).
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Adjudication method for the test set:
- Not applicable as the "ground truth" for comparison was the DRI Cocaine Enzyme Immunoassay, and confirmation was to be done by GC/MS. There is no mention of human expert adjudication in the traditional sense.
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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 is an in vitro diagnostic (IVD) device for substance detection, not an AI imaging or diagnostic device that involves human readers interpreting results in a comparative effectiveness study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance evaluation. The device itself performs the detection (immunochromatographic assay). The study compared the performance of this device against a predicate device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for comparison was the DRI Cocaine Enzyme Immunoassay (the predicate device). The intended use states that "preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS," indicating that GC/MS is considered the gold standard for confirmation. Therefore, the ground truth is a combination of comparison to a recognized predicate method and a gold standard confirmatory method (GC/MS).
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The sample size for the training set:
- Not applicable/Not specified. This is an immunoassay device, not a machine learning algorithm that requires a training set in the typical sense. The device's performance is based on its inherent chemical and immunological properties.
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How the ground truth for the training set was established:
- Not applicable. (See #7).
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).