(14 days)
"Rapid Drug Screen" 8-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel). "Rapid Drug Screen" 8-Panel test is intended for use in the qualitative detection of the following 8 drugs of abuse in human urine at the following levels:
d-Amphetamine 750 ng/ml
Barbiturates 300 ng/ml
Benzodiazepines 300 ng/ml
Benzoyl ecognine 225 ng/ml
Cannabinoids (11-nor-9-carboxy-delta-9-THC) 50 ng/ml
Methamphetamine 1000 ng/ml
Opiates (codeine) 225 ng/ml
(morphine-3-glucuronide) 225 ng/ml
Phencyclidine (PCP) 19 ng/ml
"Rapid Drug Screen" 8-Panel test is intended for use by professional laboratories and physicians offices in a clinical setting. The assays are easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary analytical test result for use in determining the need for additional or confirmatory testing (i.e., gas chromatography/mass spectrometry (GC/MS)).
"Rapid Drug Screen" 8-Panel test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
"Rapid Drug Screen" 8-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel).
The document provided is a 510(k) clearance letter from the FDA for a device called "Rapid Drug Screen" 8-Panel test. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed study information typically found in a clinical study report or a more comprehensive submission, which would detail acceptance criteria, device performance, sample sizes, ground truth establishment, etc.
Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on regulatory clearance and indications for use.
To illustrate what would be provided if the information were available, here's a hypothetical structure for the answer, assuming the device performance and study details were present:
Acceptance Criteria and Device Performance Study
This document describes the FDA's 510(k) clearance for the "Rapid Drug Screen" 8-Panel test, but it does not contain the detailed study that proves the device meets specific acceptance criteria. Such information is typically found in the full 510(k) submission, specifically in the clinical or analytical performance study sections, which are not included in this letter.
However, based on the Indications For Use and the nature of such qualitative drug screening tests, the acceptance criteria would most likely revolve around the accuracy (sensitivity and specificity) of detecting the specified drugs at or above their respective cut-off concentrations.
Below is a hypothetical example of how the requested information would be presented if it were available in the provided document:
1. A table of acceptance criteria and the reported device performance
| Drug of Abuse | Cut-off Concentration (ng/ml) | Acceptance Criteria (e.g., Sensitivity ≥ X%, Specificity ≥ Y%) | Reported Device Performance (e.g., Sensitivity, Specificity) |
|---|---|---|---|
| d-Amphetamine | 750 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 98.2%, Specificity: 97.5% |
| Barbiturates | 300 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 97.5%, Specificity: 96.8% |
| Benzodiazepines | 300 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 96.0%, Specificity: 98.0% |
| Benzoyl ecgonine | 225 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 97.0%, Specificity: 97.2% |
| Cannabinoids | 50 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 98.5%, Specificity: 96.5% |
| Methamphetamine | 1000 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 97.8%, Specificity: 97.0% |
| Opiates (codeine) | 225 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 96.3%, Specificity: 97.1% |
| Opiates (morphine-3-gluc.) | 225 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 96.5%, Specificity: 97.3% |
| Phencyclidine (PCP) | 19 | Sensitivity ≥ 95%, Specificity ≥ 95% | Sensitivity: 98.0%, Specificity: 96.9% |
2. Sample sized used for the test set and the data provenance
- Sample Size (Test Set): [Information not available in the provided document. A hypothetical example would be: "Approximately 500 urine samples (250 positive, 250 negative) for each drug target."]
- Data Provenance: [Information not available. A hypothetical example would be: "Retrospective collection from clinical laboratories in the United States and Canada."]
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: [Information not available. A hypothetical example would be: "Three clinical toxicologists and two laboratory directors."]
- Qualifications of Experts: [Information not available. A hypothetical example would be: "Board-certified clinical toxicologists with 10-15 years of experience in forensic and clinical toxicology, and laboratory directors with extensive experience in drug screening and confirmation methodologies."]
4. Adjudication method for the test set
- Adjudication Method: [Information not available. A hypothetical example would be: "All discrepancies between initial GC/MS results and expert review were resolved by a third independent expert (3+1 adjudication). For qualitative tests, the primary ground truth would be the confirmatory method, not expert adjudication of the test results itself."]
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
- MRMC Study: [Information not available. Given this is a qualitative immunoassay device from 1998, it is highly unlikely an MRMC study with AI assistance would have been conducted or applicable. This type of study is more common for imaging diagnostics with human interpretation.]
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, for this type of qualitative immunoassay, the reported performance would inherently be a standalone, algorithm-only (or device-only) performance, as it provides a direct qualitative result without human interpretation influencing the device's direct output. The human "in-the-loop" would be reading the test strip. The performance detailed in the table above would represent this standalone performance.
7. The type of ground truth used
- Ground Truth Type: [Information not available in the provided document, but for such a device, it would most certainly be:] "Confirmatory analytical methods, specifically Gas Chromatography/Mass Spectrometry (GC/MS), as explicitly mentioned in the indications for use as the preferred confirmatory method."
8. The sample size for the training set
- Sample Size (Training Set): [Information not available. For a qualitative immunoassay, the "training set" might not be a separate dataset in the same way as machine learning. It would refer to the samples used during assay development and optimization. A hypothetical example: "During assay development and optimization, hundreds to thousands of characterized urine samples (spiked and endogenous) were used."]
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): [Information not available. A hypothetical example: "For spiked samples, the concentration was precisely known. For endogenous clinical samples, the ground truth was established by independent laboratory testing using GC/MS."]
§ 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).