(139 days)
Randox Cocaine Metabolite Assay: The Randox Laboratories Ltd. Cocaine Assay is an in vitro diagnostic test for the qualitative and semiquantitative detection of Cocaine in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for Benzovlecgonine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Cocaine use or overdose. The Randox Cocaine Metabolite Assay has been developed for use on the RX series analysers, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. This assay provides only a preliminary analytical result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Randox Multidrug Calibrator Set: The Randox Multidrug Calibrator Set consists of liquid calibrators containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Cocaine and Methadone assays on the RX series analysers, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
Randox Multidrug Controls, Level 1 & 2: The Randox Multidrug Controls, level 1 and 2 are liquid controls containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Amphetamine, Barbiturates, Cocaine and Methadone assays on the RX series analysers, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
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This document describes the FDA's 510(k) clearance for the Randox Cocaine Metabolite Assay, Multidrug Calibrator Set, and Multidrug Controls Level 1 & 2. The clearance indicates that the device is substantially equivalent to a predicate device. However, the provided text does not contain the detailed study information required to fully address your request.
The document primarily focuses on the regulatory approval, intended use, and general characteristics of the device. It states that the Randox Cocaine Metabolite Assay is for the qualitative and semiquantitative detection of Cocaine in human urine, with a cutoff of 300 ng/ml for Benzoylecgonine. It also mentions the Multidrug Calibrator Set and Multidrug Controls for Amphetamine, Barbiturates, Cocaine, and Methadone assays.
Therefore, I cannot provide the specific details regarding acceptance criteria, device performance, study design, sample sizes, expert qualifications, or ground truth establishment based solely on the provided text.
To illustrate what such a response would look like if the information were available, and to help you understand what to look for in other documents, here's a template outlining the kind of information that is typically found in a submission to demonstrate acceptance criteria and device performance:
Hypothetical Section based on typical FDA submissions (Information NOT present in the provided document):
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (e.g., based on predicate device or clinical needs) | Reported Device Performance (Randox Cocaine Metabolite Assay) |
|---|---|---|
| Qualitative Mode | ||
| Sensitivity (at 300 ng/mL cut-off) | ≥ 95% | [e.g., 98.5% (95% CI: 97.2%-99.3%)] |
| Specificity (at 300 ng/mL cut-off) | ≥ 95% | [e.g., 97.8% (95% CI: 96.0%-98.9%)] |
| Accuracy (overall agreement) | ≥ 95% | [e.g., 98.1% (95% CI: 96.9%-99.0%)] |
| Semi-quantitative Mode | ||
| Accuracy (agreement within 20% of GC/MS) | ≥ 90% | [e.g., 93.2% (95% CI: 91.5%-94.7%)] |
| Precision (CV%) | ≤ 10% (Intra-assay), ≤ 15% (Inter-assay) | [e.g., Intra-assay: 5.2%, Inter-assay: 8.7%] |
| Limit of Detection (LOD) | ≤ 150 ng/mL | [e.g., 100 ng/mL] |
| Cut-off Validation (agreement at 300 ng/mL vs. GC/MS) | ≥ 95% | [e.g., 98.0%] |
2. Sample Sizes and Data Provenance for Test Set
- Sample Size for Test Set: [e.g., 500 urine samples (250 positive for Benzoylecgonine by GC/MS, 250 negative for Benzoylecgonine by GC/MS)]
- Data Provenance: [e.g., Retrospective collection from a diverse patient population undergoing routine drug screening at clinical laboratories in the United States and Europe.]
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: [e.g., 3 independent board-certified clinical toxicologists]
- Qualifications of Experts: [e.g., Each toxicologist had a minimum of 15 years of experience in forensic toxicology and drug assay validation, specializing in mass spectrometry methods.]
4. Adjudication Method for Test Set
- Adjudication Method: [e.g., Discrepancies between the initial two GC/MS results and/or clinical records were independently reviewed by a third clinical toxicologist. Final ground truth was established by consensus among at least two of the three experts.]
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Conducted?: [e.g., No, this is an in vitro diagnostic device for automated analysis; therefore, human reader assistance studies are not typically applicable.] (If it were applicable, you would see an effect size like: "Human readers' accuracy improved by X% (e.g., 10%) with AI assistance compared to without AI assistance, achieving an average AUC increase of Y (e.g., 0.05).")
6. Standalone Performance Study
- Standalone Performance Study Conducted?: Yes. The clinical performance study detailed in section 1 evaluated the device's performance (sensitivity, specificity, accuracy) independently without human intervention, as it is an automated assay.
7. Type of Ground Truth Used (Test Set)
- Type of Ground Truth: Gold standard Gas Chromatography/Mass Spectrometry (GC/MS) results for Benzoylecgonine concentration in urine samples, correlated with clinical review of patient records where applicable.
8. Sample Size for Training Set
- Sample Size for Training Set: [e.g., Not applicable for this type of immunoassay-based device in the same way it would be for a typical machine learning algorithm. The "training" phase for such an assay involves extensive analytical validation, calibration curve generation, and quality control optimization using hundreds to thousands of samples with known analyte concentrations for reagent development, instrument optimization, and establishment of performance specifications.]
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: [e.g., For immunoassay development, ground truth is typically established through serial dilutions of certified reference materials, spiked samples with known concentrations of Benzoylecgonine, and samples cross-validated against GC/MS during the assay development and optimization phases. This ensures reagent specificity, linearity, and accurate quantitation.]
Summary of Information from the Provided Document:
- Device Name: Randox Cocaine Metabolite Assay, Multidrug Calibrator Set, and Multidrug Controls Level 1 & 2.
- Intended Use (Cocaine Assay): In vitro diagnostic test for qualitative and semiquantitative detection of Cocaine (Benzoylecgonine) in human urine.
- Cut-off (Cocaine Assay): 300 ng/ml for Benzoylecgonine.
- Semi-quantitative Use Cases: Determining appropriate dilution for GC/MS confirmation and establishing quality control.
- Confirmatory Method: Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method.
- Platform: RX series analysers (RX Daytona and RX Imola).
- Prescription Use: Intended for prescription use only.
- Multidrug Calibrator/Controls: Contain Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine, and Methadone for calibration/QC of Amphetamine, Barbiturates, Cocaine, and Methadone assays on RX series analysers.
To obtain the detailed study information, you would typically need to consult the full 510(k) submission available through the FDA's substantial equivalence database or directly from the manufacturer, as the provided "Indication for Use" document is only a summary.
§ 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).