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Instant-View™ Morphine Urine Dip Strip Test is a qualitative immunoassay device intended to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is for health care professional use only.

Instant-View Morphine Urine Dip Strip Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only.

This test is a one-step lateral flow chromatographic immunoassay.

Here's a breakdown of the acceptance criteria and study information for the Instant-View™ Morphine Urine Dip Strip Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample size for the test set. It mentions "results from the Clinical Laboratory and three Physician's Offices." Without specific numbers, it is not possible to determine the precise sample size.

Regarding data provenance:

• Country of Origin: Not specified, but likely the USA given the FDA 510(k) submission.
• Retrospective or Prospective: Not explicitly stated. The phrasing "results from the Clinical Laboratory and three Physician's Offices" suggests a prospective study, but this is not confirmed.

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

The document does not mention the number of experts used to establish ground truth or their specific qualifications. It only states that the accuracy evaluation was "conducted by persons with diverse educational background and working experience." This implies that the "expected results" (ground truth) were established by a reference method rather than expert consensus on interpretation of the test device results.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. The accuracy was determined by comparing the device's results to "expected results," which likely implies a single reference method result was used as the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a rapid diagnostic test (lateral flow immunoassay) for detecting morphine, not an AI-assisted diagnostic tool that aids human interpretation of complex medical images or data.

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

The device itself is a standalone, qualitative immunoassay. The performance described (correlation and accuracy) is its intrinsic performance for detecting morphine in urine. There is no "algorithm" in the traditional sense of AI, but rather a biochemical reaction. The "standalone" performance here refers to the test strip's ability to produce a result without further human interpretation beyond reading the C and T lines.

7. The Type of Ground Truth Used

The ground truth used for accuracy evaluation was referred to as "expected results." While not explicitly stated, for drug screening devices, this typically refers to:

• Known concentrations: Spiking urine samples with known concentrations of morphine both above and below the cutoff.
• Reference method: Comparison to a gold standard analytical method like Gas Chromatography/Mass Spectrophotometry (GC/MS), which is explicitly mentioned as the "preferred confirmatory method" for preliminary positive results.

8. The Sample Size for the Training Set

The document does not provide information about a "training set." This type of immunoassay device does not typically involve a machine learning training phase in the same way an AI algorithm would. Its development is based on biochemical principles and validation.

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

As there is no mention of a training set in the context of machine learning, there is no information on how a ground truth for such a set was established.

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