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'Rapid Drug Screen' 5-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of 5 abused substances in urine (each assay occupies a separate channel). 'Rapid Drug Screen' 5-Panel test is intended for use in the qualitative detection of the following 5 drugs of abuse in human urine at the following levels:

d-Amphetamine 1000 ng/ml
Benzoyl ecgonine 300 ng/ml
Cannabinoids 50 ng/ml
Opiates 300 ng/ml
Phencyclidine (PCP) 25 ng/ml

'Rapid Drug Screen' 5-Panel test is intended for professional use. It is not intended for over the counter sale to non-professionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).

'Rapid Drug Screen' 5-Panel test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The assays employed in the 'Rapid Drug Screen' - 5-Panel are based on the same principle of highly specific reaction between antigens and antibodies.

Each assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on the antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal goldantibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the 'test' area. The formation of a visible line in the test area occurs when the test is negative.

When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-antibody complex. If sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the test area is indicative of a positive result.

A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence of absence of drug in the urine, and therefore, should be present in all reactions.

A negative urine will produce two colored bands, and a positive sample will produce only one band.

Here's a breakdown of the acceptance criteria and study information for the K993151 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are its ability to detect specific drugs at predefined concentration levels, which are also the reported performance characteristics.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "The sensitivity, reproducibility and accuracy for each of the assays have cleared the 510(k) process." without providing details of the studies to demonstrate this.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide any information about the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication method for the test set

The document does not specify any adjudication method used for the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance.

This device is a qualitative immunoassay for drug detection, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance was not relevant or performed for this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This device is an immunoassay, which is a standalone chemical test. Its performance is evaluated purely based on its ability to detect the target substances at specified concentrations in a sample. Therefore, yes, a standalone performance evaluation was done as the device operates without human-in-the-loop performance for result generation, though human interpretation of the visual lines is required.

7. The type of ground truth used

The ground truth for this type of immunoassay would typically be established by:

• Known concentrations of drugs in spiked urine samples: This allows for precise control of the target analyte's presence and concentration. This is implied by the "detection levels" mentioned.
• Confirmatory analytical methods: The document explicitly states that the immunoassay "provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas chromatography/mass spectrometry (GC/MS)." This indicates that GC/MS is considered the gold standard for confirmation and would likely be used to establish ground truth for testing.

8. The sample size for the training set

The document does not specify the sample size for any training set. Given that this is an immunoassay and not an algorithmic device in the modern AI sense, the concept of a "training set" as it relates to machine learning is not applicable here. The development of such assays typically involves optimizing reagents and conditions rather than training an algorithm.

9. How the ground truth for the training set was established

As noted above, a "training set" in the context of an AI algorithm is not applicable here. The development of the immunoassay's ability to detect drugs at specific levels would have involved laboratory experiments using:

• Known concentrations of target drugs: The ground truth for optimizing the assay would be the actual, known concentration of the drugs in the samples used during development.
• Reference methods (e.g., GC/MS): During development, comparison against established, highly accurate methods like GC/MS would be used to ensure the immunoassay's accuracy at its specified cut-off levels.

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