(161 days)
For use in the qualitative analysis of cocaine metabolite (benzoylecgonine) in human urine at a cutoff concentration of
FRONTLINE® COCAINE is a homogeneous immunochromatographic assay for use in the qualitative analysis of cocaine metabolite (benzoylecgonine) in human urine. The assay is based on Gold Labeled Optical-read Rapid Immuno Assay (GLORIA) technology. Each test strip contains monoclonal antibodies reactive to a benzoylecgonine derivative labeled with colloidal gold (conjugate) and benzoylecgonine polyhapten, bulking agents, stabilizers and preservatives (solid phase). When immersed in urine, the test strip absorbs the volume of fluid necessary for the chromatographic reaction to occur. By capillary action, the urine passes through a compartment containing soluble conjugate which specifically binds to the benzoylecgonine analyte. Excess conjugate is retained by the solid phase in a separate compartment. Only that conjugate with bound-benzoylecgonine analyte passes to the detection pad where a red-colored conjugate-analyte complex is viewed. The color developed on the detection pad is compared visually with a scale provided on the test strip vial. The intensity of the color developed correlates with the concentration of the analyte in the sample and the user may classify the analyte sample as: negative or positive (≥300 ng/mL).
Here's a breakdown of the acceptance criteria and study details for the FRONTLINE® COCAINE device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Qualitative Analysis for Cocaine Metabolite (Benzoylecgonine) in Human Urine at a Cutoff Concentration of ≥300 ng/mL: The device should accurately classify samples as positive or negative based on the cutoff. | Agreement with FPIA and Confirmation Method: Of 513 samples:58 samples were FRONTLINE® positive450 samples were FRONTLINE® negative5 samples were classified as false positive by FRONTLINE® COCAINE when compared to FPIA and the confirmation method. |
| Accuracy in identifying positive samples. | 58 samples identified as positive, which agreed with the reference methods. |
| Accuracy in identifying negative samples. | 450 samples identified as negative, which agreed with the reference methods. |
| Low rate of false positives. | 5 false positive samples out of 513 total. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 513 metabolized urine samples.
- Data Provenance: Not explicitly stated whether the data was retrospective or prospective, nor the country of origin. However, the study involved "two sites," suggesting a multicenter evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The ground truth was established by comparison to a predicate device (TDx® Cocaine Metabolite, which is a fluorescence polarization immunoassay or FPIA) and a "confirmation method," but details on expert involvement in establishing this ground truth are missing.
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Adjudication method for the test set:
- This information is not provided in the text. The assessment involved comparison to FPIA and a confirmation method, but how discrepancies were resolved (e.g., 2+1, 3+1) is not described.
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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:
- No. This device is described as an "immunochromatographic test" and "non-instrumented assay" that requires visual comparison with a scale. It is not an AI-assisted device, and therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, effectively. While not an algorithm in the modern AI sense, the FRONTLINE® COCAINE device itself is a standalone test that provides a qualitative result (positive/negative) through visual interpretation. The study evaluates the performance of this standalone device against reference methods without human intervention influencing the device's output. Human "reading" is part of the intended use, comparing the developed color to a scale.
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The type of ground truth used:
- The ground truth was established by a combination of a predicate device (TDx® Cocaine Metabolite, an FPIA) and a "confirmation method." This suggests a highly reliable, laboratory-based established method for determining actual cocaine metabolite presence.
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The sample size for the training set:
- This information is not provided in the text. The provided data relates to a performance evaluation (test set), not a training set. As this is not an AI/machine learning device, the concept of a "training set" in that context may not apply directly.
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How the ground truth for the training set was established:
- This information is not provided as a training set is not explicitly mentioned or defined in the context of this device's development or evaluation in the provided text.
§ 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).