(223 days)
Instant-View Anıphetamine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect amphetamine in human urine at a cutoff level of 1000 ng/ml. It is intended for health care professional use only.
This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
This test is a one-step lateral flow chromatographic immunoassay.
The Instant-View™ Amphetamine Urine Cassette Test is a qualitative immunoassay device manufactured by Alfa Scientific Designs, Inc. It is intended for health care professionals to detect Amphetamine in human urine at a cutoff level of 1000 ng/ml.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (like minimum sensitivity or specificity percentages). However, based on the Discussion and Conclusion section, we can infer the performance targets assessed during the comparison study.
| Acceptance Criterion (Inferred) | Reported Device Performance | Met? |
|---|---|---|
| Correlation with Predicate Device | Higher than 94.6% correlation with the legally marketed test device. | Yes |
| Agreement across POL sites | 95.0% agreement across all three POL sites. | Yes |
| Accuracy (Clinical Lab & POL) | 92.2% agreement with expected results. | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set. It mentions "Clinical Laboratory and the three Physician's Offices Laboratory" but doesn't quantify the number of samples.
The data provenance is likely retrospective as it involves comparison with a "legally marketed test device." The "three POL sites" and "Clinical Laboratory" suggest the data was collected in a clinical setting. The country of origin is not explicitly stated, but given the submitter's address in San Diego, CA, and the FDA's involvement, it can be inferred that the data primarily originates from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set. It only mentions that the "Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices Laboratory conducted by persons with diverse educational backgrounds and working experience agreed 92.2 % with the results expected." This suggests that the ground truth was established by laboratory personnel or healthcare professionals in those settings, but their specific qualifications or the number involved are not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on the device's performance compared to a predicate device and accuracy against expected results, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was implicitly done. The Instant-View™ Amphetamine Urine Cassette Test is a qualitative immunoassay device, which means it provides a result directly without requiring human interpretation that would be enhanced by AI. The "Accuracy Evaluation" and "Correlation of results" compare the device's output to established truths or another device's output, indicating a standalone assessment of its performance.
7. The Type of Ground Truth Used
The ground truth used appears to be a combination of:
- Reference Device Output: The "legally marketed test device" (QuikStrip OneStep Amphetamine Test, K971218) served as a comparative ground truth for correlation.
- Expected Results: For the "Accuracy Evaluation," the device's results were compared to "results expected," which likely refers to confirmatory laboratory methods (such as GC/MS, as mentioned in the "Indications For Use" as the preferred confirmatory method) or known concentrations of amphetamine in urine samples.
8. The Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. This device is a biochemical immunoassay, not a machine learning or AI-based algorithm that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, there is no "training set," and therefore, no ground truth needed to be established for a training set. The device's performance is based on its intrinsic chemical and immunological properties.
§ 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).