(29 days)
CR3 Keyless Split Sample Cup Secobarbital-Methadone is a rapid test for the qualitative detection of Secobarbital and Methadone in human urine at a cutoff concentration of 300ng/mL for each of the drugs.
The test may yield preliminary positive results when prescription drugs Secobarbital and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital and Methadone in urine. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.
For in vitro diagnostic use only.
The CR3 Keyless Split Sample Cup Secobarbital - Methadone test uses immunochromatographic assays for secobarbital and methadone. The test is a lateral flow system for the qualitative detection of secobarbital and methadone in human urine. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
Here's a breakdown of the acceptance criteria and study information for the CR3 Keyless Split Sample Cup Secobarbital-Methadone device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate section with specific numerical targets. Instead, it describes performance characteristics that would be used to demonstrate substantial equivalence to a predicate device. For the purpose of this response, I've interpreted the demonstrated performance in the "Performance Characteristics" section as meeting assumed acceptance criteria for effective drug detection. The key performance indicators addressed are precision, cut-off values, interference, specificity, and comparison to GC/MS.
Since this is a qualitative test, metrics like sensitivity, specificity, and accuracy are inferred from the comparison study and precision data, rather than being explicitly stated as separate acceptance criteria with target percentages for positive/negative agreement.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Qualitative Detection | Must accurately detect Secobarbital and Methadone qualitatively in urine. | The device provides preliminary positive or negative results. Confirmed by GC/MS. |
| Cut-off Concentration | 300 ng/mL for Secobarbital and Methadone. | Verified at 300 ng/mL for both Secobarbital and Methadone. |
| Precision | Consistent and reliable results across operators and runs for concentrations around the cut-off. | For concentrations below 25% of cut-off, 100% negative results. For concentrations above 25% of cut-off, 100% positive results. At the cut-off, good agreement (e.g., Secobarbital: 41-43 positive out of 50 tests). |
| Linearity | Not applicable for a qualitative test. | Not applicable. |
| Stability | Stable for a reasonable shelf life. | Stable at 4-30°C for 18 months. |
| Interference | Minimal interference from common substances and physiological conditions. | No interference from a long list of compounds at 100ug/mL. Performance not affected by varying specific gravity and pH. |
| Specificity | Differentiate between target drugs and structurally similar compounds. | Detailed cross-reactivity data provided for Secobarbital and Methadone, showing varying degrees of cross-reactivity with related substances at different concentrations. |
| Comparison to GC/MS (Analytical Accuracy) | High concordance with GC/MS for both negative and positive samples. | Secobarbital: |
| Viewer A: 0 false negatives high/low positive, 4 false positives near cutoff negative | ||
| Viewer B: 0 false negatives high/low positive, 3 false positives near cutoff negative | ||
| Viewer C: 0 false negatives high/low positive, 3 false positives near cutoff negative | ||
| Methadone: | ||
| Viewer A: 0 false negatives high/low positive, 3 false positives near cutoff negative | ||
| Viewer B: 0 false negatives high/low positive, 5 false positives near cutoff negative | ||
| Viewer C: 0 false negatives high/low positive, 4 false positives near cutoff negative | ||
| (Results are grouped and not shown as overall percentage agreement.) | ||
| Lay-User Interpretability | The device should be easily used and interpreted by lay users. | 100% agreement for drug-free, -75%, -50% cut-off samples. 80-85% agreement for -25% and +25% cut-off samples. 100% agreement for +50% and +75% cut-off samples. Instructions easily followed, reading grade level below 7. |
2. Sample Size Used for the Test Set and Data Provenance
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Precision Study:
- For each concentration level (-100% cut-off, -75%, -50%, -25%, at cut-off, +25%, +50%, +75%, +100% cut-off): 50 tests (performed 2 runs/day by 3 operators for 25 days, which means 25 days * 2 runs/day * 1 test/run = 50 tests per operator for each concentration level. However, the tables show combined results for W12010501CU5, W12010502CU5, W12010503CU5, suggesting these are the operators, each performing 50 tests for each concentration).
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Cut-off Verification:
- 125 Secobarbital samples and 125 Methadone samples.
-
Interference Study:
- Not specified as a number of samples, but target drugs were spiked into urine with potential interferents at 25% below and 25% above the cut-off.
-
Specificity Study:
- Not specified as a number of samples, but drug metabolites and related compounds were tested at different concentrations.
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Comparison Studies (Lab-based):
- 80 unaltered clinical samples (40 negative and 40 positive) for Secobarbital.
- 80 unaltered clinical samples (40 negative and 40 positive) for Methadone.
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Lay-User Study:
- 260 lay persons.
- 20 drug-free samples.
- 120 Secobarbital samples (across different concentrations).
- 120 Methadone samples (across different concentrations).
-
Data Provenance: The document does not explicitly state the country of origin for the clinical samples. The precision and analytical studies appear to be "in-house" (performed by the manufacturer). The comparison study used "unaltered clinical samples." The lay-user study was performed "at three intended user sites." The data appears to be retrospective as samples were collected and then tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Ground Truth Establishment for Comparison Studies (Lab-based):
- Method: Gas Chromatography/Mass Spectrometry (GC/MS).
- Experts: The specific number and qualifications of experts performing the GC/MS analysis are not mentioned. GC/MS is an objective analytical method, so "experts" in the sense of clinical decision-makers might not be directly applicable for establishing the ground truth concentrations. However, skilled laboratory personnel are required to operate and interpret GC/MS results.
- Ground Truth Establishment for Lay-User Study:
- Method: GC/MS was used to confirm the concentrations of the spiked urine samples.
- Experts: Not explicitly stated, as above.
4. Adjudication Method for the Test Set
- Precision Study: "All sample aliquots were masked and randomized." Results were presented by operator but no explicit adjudication method (e.g., 2+1) is mentioned for discrepancies.
- Comparison Studies (Lab-based): "The samples were masked and randomized." The results of the device were compared to GC/MS. No explicit adjudication method is mentioned. The comparison study involved three "Viewer" operators (Viewer A, B, C) who manually read the device results. Their individual discordant results with GC/MS are listed, but there's no mention of a consensus or adjudication process among these viewers.
- Lay-User Study: Samples were "blind-labeled and randomized." There is no mention of an adjudication method for participant readings. The agreement is reported as a percentage with GC/MS.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was explicitly done to assess how much human readers improve with AI vs. without AI assistance.
- The study involved multiple readers (three lab assistants in the comparison study, and 260 lay users in the lay-user study) and multiple cases. However, it was a standalone device performance study comparing the device output (read by humans) to a reference standard (GC/MS), not a comparative effectiveness study of human performance with vs. without AI. The device itself is a simple, qualitative rapid test, not an AI-assisted diagnostic tool.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in essence, the fundamental performance of the device itself (the "algorithm" in a chemical sense) was evaluated standalone. The precision, cut-off, interference, and specificity sections describe the inherent analytical performance of the test strips. The "viewers" in the comparison study are interpreting the visual lines on the device, rather than interacting with an algorithm that provides output. The device itself is a standalone qualitative test.
7. Type of Ground Truth Used
- Analytical Chemical Method (GC/MS): For both the internal performance characterization (precision, cut-off verification, interference, specificity) and the comparison studies, Gas Chromatography/Mass Spectrometry (GC/MS) was used as the reference standard to establish the ground truth concentrations of Secobarbital and Methadone.
8. Sample Size for the Training Set
- Not Applicable / Not Mentioned. This is a chemical assay (immunochromatographic), not a machine learning or AI-based device that typically requires a "training set." The development of such assays involves chemical optimization and validation, rather than a separate training phase with a distinct dataset.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Mentioned. As noted above, there isn't a "training set" in the context of this device type. The ground truth for analytical validation (e.g., precision, specificity, calibration) would be established by preparing samples with known concentrations using high-purity standards and analytical techniques like GC/MS.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).