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Instant-View Cocaine (Benzoylecgonine) Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect benzoylecgonine, a metabolite of cocaine in human urine at a cutoff level of 300 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 an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:

Device: Instant-View™ Cocaine (Benzoylecgonine) Urine Cassette Test

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for overall performance. Instead, it reports the performance achieved and then concludes that based on these results, the device is suitable and substantially equivalent.

However, we can infer performance metrics that were evaluated and achieved:

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

• Sample Size: The document mentions "Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices Laboratory." It also references "Raw Data for Accuracy Study from the three POL sites and the Reference Laboratory" and "Tabulated Results (Ascending Concentration) of the Accuracy Study... with the GC/MS Data". However, the specific number of samples used in the accuracy study (test set) is not explicitly stated in the provided text.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, and the Toxicology Laboratory (Unilab Corporation) is located in Tarzana, CA, USA. This suggests the data is likely from the USA.
  • Retrospective or Prospective: Not explicitly stated. Given the nature of a 510(k) submission for a diagnostic device, these are typically prospective studies where samples are collected and tested using the new device and a reference method. However, without explicit mention, it cannot be definitively confirmed.

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

• Number of Experts: The document details an "Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices Laboratory conducted by persons with diverse educational backgrounds and working experience". However, it does not specify the number of individual experts or operators involved in establishing the ground truth or conducting the studies, beyond referring to "persons" and "diverse educational backgrounds and working experience."
• Qualifications: While it mentions "diverse educational backgrounds and working experience" for those conducting the evaluation, it does not provide specific qualifications like "radiologist with 10 years of experience." The context implies these are healthcare professionals or laboratory personnel. The reference laboratory (Unilab Corporation, Toxicology Laboratory) provides the gold standard GC/MS data, implying their staff are qualified in toxicology analysis.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The accuracy study compares the device's results against "results expected" which are derived from a "Reference Laboratory" using GC/MS data. This suggests a direct comparison to a gold standard, rather than a concensus among multiple human readers of the device itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs without AI assistance. This device is a rapid diagnostic test (cassette immunoassay), not an AI-assisted diagnostic tool that would typically involve human readers interpreting complex images or data with or without AI assistance. Therefore, this section is not applicable to the submitted device.

6. Standalone (Algorithm Only) Performance

This device is a standalone immunoassay cassette test. Its performance inherently represents its "standalone" (algorithm only) capability for detecting Benzoylecgonine. There is no separate "human-in-the-loop" component to consider for this type of test, distinct from the test itself being operated by a person. The reported accuracy and correlation data reflect its standalone performance.

7. Type of Ground Truth Used

The primary ground truth used for the accuracy study was:

• GC/MS Data (Gas Chromatography/Mass Spectrophotometry): This is explicitly mentioned as the "preferred confirmatory method" and the "GC/MS Data the Toxicology Laboratory" was used in the Accuracy Study. This is generally considered a highly accurate and definitive method for drug detection and quantification in toxicology.
• Predicate Device Comparison: Correlation with a legally marketed predicate device (QuikStrip One Step Cocaine Test) also served as a comparative ground truth.

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI components. The Instant-View™ Cocaine (Benzoylecgonine) Urine Cassette Test is described as a "one-step lateral flow chromatographic immunoassay," which is a traditional laboratory diagnostic device, not an AI/ML-based device that would require a distinct training set.

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

As there is no mention of a training set for an AI/ML model, this question is not applicable to the described device.

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