(57 days)
The Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semi-quantitative detection of amphetamine and methamphetamine and their metabolites in human urine. Periodate may be used in conjunction with Abuscreen ONLINE for Amphetamines to minimize interference which may be caused by the presence of ßhydroxamine compounds in urine samples.
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This document is an FDA 510(k) clearance letter for the "Abuscreen ONLINE for Amphetamines with Periodate Olympus AU800/1000" device, which is an in vitro diagnostic test. The letter itself does not contain the detailed acceptance criteria or the study results proving the device meets them. It primarily states that the device is substantially equivalent to previously marketed devices.
To answer your request, I would need to access the actual 510(k) submission document (K972891) referenced in this letter. That document would contain the specific performance data, acceptance criteria, study design, and statistical analysis.
However, based only on the provided FDA letter, I can infer some information about the device and the general nature of its intended use:
Device Name: Abuscreen ONLINE for Amphetamines with Periodate Olympus AU800/1000
Intended Use (from Page 2 of the document titled "Indications for Use"):
"The Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semi-quantitative detection of amphetamine and methamphetamine and their metabolites in human urine. Periodate may be used in conjunction with Abuscreen ONLINE for Amphetamines to minimize interference which may be caused by the presence of B-hydroxamine compounds in urine samples."
Given the nature of the device as an in vitro diagnostic test for drug detection, the acceptance criteria would typically revolve around:
- Sensitivity: The ability of the test to correctly identify positive samples (true positive rate).
- Specificity: The ability of the test to correctly identify negative samples (true negative rate).
- Accuracy: Overall agreement with a reference method.
- Precision/Reproducibility: Consistency of results when the test is run multiple times on the same sample.
- Interference: Evaluation of substances that might falsely affect results (e.g., the mention of "Periodate... to minimize interference which may be caused by the presence of B-hydroxamine compounds").
- Cut-off values: The threshold at which a sample is considered positive.
- Cross-reactivity: Assessment of other compounds that might produce a false positive.
Without the actual 510(k) submission (K972891), I cannot provide the specific numerical acceptance criteria or the detailed study results.
However, I can provide a general framework of what the acceptance criteria table and study details would likely have contained for this type of device, based on typical FDA IVD submission requirements:
Hypothetical Acceptance Criteria and Reported Device Performance (Based on Typical IVD Submissions):
| Acceptance Criteria Category | Specific Metric (Hypothetical) | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|---|
| Sensitivity | Positive Percent Agreement (PPA) with GC/MS reference method | ≥ 95% | 98.5% (for Amphetamine) |
| 97.2% (for Methamphetamine) | |||
| Specificity | Negative Percent Agreement (NPA) with GC/MS reference method | ≥ 98% | 99.1% |
| Accuracy | Overall Agreement with GC/MS reference method | ≥ 96% | 98.8% |
| Cut-off Performance | % detection at ±25% of cut-off (e.g., 500 ng/mL for AMP) | Detect ≥ 95% of samples at +25% | |
| Detect ≤ 5% of samples at -25% | Met for both Amphetamine and Methamphetamine | ||
| Precision (Within-run) | %CV on known positive/negative controls | ≤ 10% | 200` clinical urine samples (e.g., 100 positive, 100 negative) for clinical performance, and additional samples for interference, cross-reactivity, and precision testing. |
* **Data Provenance:** (Likely **prospective** or a mix of **retrospective and prospective**) human urine samples collected from various sources (e.g., drug treatment centers, clinical laboratories, healthy volunteers) in the **United States**. The specific "country of origin" is usually the location of the clinical sites where samples were collected and tested.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* For a drug screening test like this, the "ground truth" is typically established by a definitive analytical method, not human expert consensus on interpretations.
* Ground Truth Method: Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS) is the gold standard for confirming the presence and concentration of drugs in urine.
* "Experts": The analysis would be performed by highly qualified laboratory personnel (e.g., clinical chemists, toxicologists) with extensive experience (e.g., 5-10+ years) in operating and interpreting results from GC/MS or LC/MS systems in a certified clinical or forensic toxicology laboratory. The "number of experts" refers less to a consensus panel and more to the personnel performing the reference method testing, usually a team within the laboratory.
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Adjudication method for the test set:
- None, in the traditional sense of human review. The ground truth (GC/MS or LC/MS results) serves as the definitive reference. Discrepant results between the investigational device and the reference method would be investigated analytically, not through expert adjudication.
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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 is an in vitro diagnostic (IVD) device, a laboratory assay. It does not involve human readers interpreting images or complex data in the same way an AI-powered diagnostic imaging device would. The "reading" is automated by the instrument (Olympus AU800/1000), which produces a reportable result (qualitative positive/negative or semi-quantitative concentration). Therefore, an MRMC study and human reader improvement metrics are not applicable here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. This device is a standalone algorithm/assay in the context of its operation. The Olympus AU800/1000 system processes the samples, and the "Abuscreen ONLINE for Amphetamines" reagent system and associated assay parameters within the instrument perform the detection without human interpretive intervention beyond loading samples and reviewing the automated results.
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The type of ground truth used:
- Definitive analytical method: Specifically, Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS) results, which are considered the gold standard for drug confirmation and quantification in urine.
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The sample size for the training set:
- For a traditional immunoassay-based IVD like this cleared in 1997, there wouldn't typically be a "training set" in the machine learning sense. The assay parameters (e.g., reaction kinetics, absorbance thresholds) are developed and optimized by the manufacturer through analytical studies using characterized samples (e.g., spiked samples, known clinical positives/negatives). The sample size for such development and optimization would vary but would involve numerous runs across different concentrations and matrices.
- If any calibration curve development is considered "training," that would involve a smaller set of calibrator samples.
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How the ground truth for the training set was established:
- Again, not a "training set" in the AI sense. For the development and optimization of the assay's performance characteristics, ground truth for characterized samples (e.g., spiked samples, known clinical positives/negatives) would have been established using GC/MS or LC/MS. For calibrators, the concentrations are precisely prepared and verified using gravimetric and analytical methods traceable to certified reference materials.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).