(41 days)
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of amphetamine, a central nervous system stimulating drug, in urine. Measurements that are 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.
The QuickScreenTM One Step Amphetamine Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse (amphetamine) test kits, to qualitatively measures the presence of amphetamine by visual color sandwich one step immunoassay technology.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the QuickScreen™ One Step Amphetamine Screening Test:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state pre-defined acceptance criteria (e.g., "must achieve >X% sensitivity"). Instead, it compares the device's performance to established methods as evidence of substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation | Must demonstrate high correlation (e.g., >97%) with established laboratory methods (Syva EMIT II and GC/MS). | >97% correlation when compared to Syva EMIT II and GC/MS. |
| Sensitivity | Must exhibit excellent sensitivity in the hands of professional laboratory technicians. | 83/84 (98.8%) |
| Specificity | Must exhibit excellent specificity in the hands of professional laboratory technicians. | 40/40 (100%) |
| Accuracy | Must exhibit excellent accuracy in the hands of professional laboratory technicians. | 123/124 (99.2%) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The summary mentions two types of studies:
- "Clinical sample correlation study"
- "Blind labeled amphetamine study"
- "Two clinical laboratory studies"
- Sample Size:
- For the sensitivity calculation: 84 samples (83 true positive detections).
- For the specificity calculation: 40 samples (40 true negative detections).
- For the accuracy calculation: 124 samples (123 correct detections).
- The total number of samples used in the "clinical sample correlation study" is not explicitly stated, only the correlation percentage.
- Data Provenance: The data is from "clinical specimens" and "clinical laboratory studies," implying human urine samples.
- Country of Origin: Not specified.
- Retrospective or Prospective: Not explicitly stated, but "clinical sample correlation study" and "blind labeled amphetamine study" typically imply prospective or a mix of prospective/retrospective samples with a known status. The clinical laboratory studies would likely involve testing samples in a controlled lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth was established by comparison to the Syva EMIT II and GC/MS methodology. These are considered gold standard methods for drug detection.
- The summary does not specify a number of human experts for establishing ground truth, rather relying on established laboratory methods.
- The studies were performed "in the hands of professional laboratory technicians," implying qualified clinical laboratory personnel were involved in performing both the experimental device tests and likely the comparator tests (Syva EMIT II, GC/MS). Their specific qualifications (e.g., years of experience) are not provided.
4. Adjudication Method for the Test Set
- The summary does not describe a formal adjudication method (e.g., 2+1 adjudicator scheme).
- Ground truth was based on the results from the Syva EMIT II and GC/MS methods. Discrepancies between the Phamatech QuickScreen™ and these methods would be resolved by the established methods being the "truth."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not explicitly described.
- This device is a qualitative immunoassay for amphetamine and its performance assessment focuses on its standalone accuracy against established lab methods, not on human reader improvement with AI assistance. The concept of "AI assistance" is not relevant to this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
- Yes, the performance metrics (sensitivity, specificity, accuracy) are reported for the device in standalone mode. The device itself performs the detection, with professional laboratory technicians performing the test according to its instructions and interpreting the visual color change. While human interpretation of the color change is involved, the reported metrics reflect the device's intrinsic capability to produce the correct visual signal.
7. Type of Ground Truth Used
- The ground truth used was based on established laboratory methods:
- Syva EMIT II: An immunoassay that serves as a predicate device or a common comparative method in clinical toxicology.
- GC/MS (Gas Chromatography/Mass Spectrometry): Considered the gold standard confirmatory method for drug testing, providing highly accurate and specific identification and quantification of substances.
8. Sample Size for the Training Set
- The 510(k) summary does not provide information on the training set size. Regulatory submissions for such immunoassay devices typically focus on the performance of the final, locked-down device rather than detailing the internal development and training data if an "AI" or machine learning component isn't explicitly part of the submission. The device uses "colloidal gold technology" following "immunochemical sandwich assay principle," which is a biochemical assay, not an AI-driven device.
9. How the Ground Truth for the Training Set Was Established
- Since there's no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable. The device's underlying technology (immunoassay) is based on chemical reactions, not on learning from a dataset. The "development" of such a device would involve optimizing reagents and assay parameters based on known concentrations and interferences, not "training" an algorithm in the modern sense.
§ 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).