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Instant-View™ Amphetamine Urine Dip Strip Test is a qualitative immunoassay device intended to be used for detecting Amphetamine in human urine at a cutoff level of 1000 ng/ml. It is for health care professional use only.

Instant-View Amphetamine Urine Dip Strip 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.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided 510(K) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The provided document does not explicitly state numerical acceptance criteria in a dedicated section. Instead, these are inferred from the reported performance results and the conclusion that the device is "substantially equivalent." For example, the 94.2% correlation with the predicate and 92.2% accuracy are presented as evidence of meeting acceptable performance, rather than being compared against a pre-defined threshold. The 95.0% agreement across POL sites further supports its practical utility.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It mentions "results from all three POL sites" and "Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices." This indicates that the testing involved multiple clinical environments and an internal clinical laboratory, suggesting a multi-site evaluation.

Data Provenance:

• Country of Origin: Not explicitly stated, but given Alfa Scientific Designs, Inc. is in San Diego, CA, and the FDA approval, it is highly likely the data was collected in the United States.
• Retrospective or Prospective: Not explicitly stated. However, the nature of a 510(k) submission for a new device typically involves prospective testing to demonstrate performance under controlled conditions. The "Accuracy Evaluation" and "Comparison Studies" would involve newly generated data from testing the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts or their specific qualifications for establishing ground truth for the test set.

However, it does mention that the "Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices conducted by persons with diverse educational backgrounds and working experience agreed 92.2 % with the results expected." This implies that the 'ground truth' or 'expected results' were either:

• Established by standard laboratory methods at a clinical laboratory.
• Determined by the "legally marketed test device" (the predicate device) in the comparison study.

Given the device type (amphetamine urine dip strip), the initial assessment would likely be compared against a more robust laboratory method or the established performance of the predicate. The "persons with diverse educational backgrounds and working experience" refers to the users testing the device, not necessarily the experts establishing ground truth for each sample.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The "ground truth" for the comparison study appears to be the results obtained from the predicate device (QuikStrip OneStep Amphetamine Test) and, for the accuracy evaluation, "expected results" likely derived from a validated laboratory method (e.g., GC/MS, though not explicitly stated as the ground truth method for the entire comparison).

The agreement percentages (94.2% with predicate, 92.2% accuracy) suggest a direct comparison of the test device's result against the established reference.

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 in the context of human readers improving with AI vs. without AI assistance. This device is a rapid diagnostic test (dip strip) that provides a qualitative result. It is not an AI-powered diagnostic imaging or interpretation tool that would typically involve human readers and AI assistance. The study focuses on the device's performance against a predicate and expected lab results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable in the typical sense of standalone AI algorithm performance. The device itself is a "standalone" chemical immunoassay test that provides a result, which is then interpreted by a healthcare professional. There is no "human-in-the-loop" in terms of an AI algorithm assisting interpretation; the human reads the dip strip directly. The performance metrics presented (correlation, agreement, accuracy) are indicative of the device's standalone analytical performance.

7. The Type of Ground Truth Used

The ground truth appears to be a combination of:

• Predicate Device Results: For the "Comparison Studies," the results of the legally marketed QuikStrip OneStep Amphetamine Test (K971218) served as a comparative ground truth.
• Expected Results (likely from reference laboratory methodology): For the "Accuracy Evaluation results from the Clinical Laboratory" these "expected results" would generally come from a highly accurate and validated method, such as Gas Chromatography/Mass Spectrophotometry (GC/MS), which is explicitly mentioned as the "preferred confirmatory method" in the Indications for Use. While not explicitly stated that GC/MS was the method for defining ground truth in the study, it's the gold standard for confirmation.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is expected as the Instant-View™ Amphetamine Urine Dip Strip Test is a chemical immunoassay, not a machine learning or AI-based device that typically requires a training set. Its development would involve chemical and biological engineering, not algorithmic training.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" for this type of device.

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