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The Advin Multi-Drug Screen Test is a one-step immunoassay for the qualitative detection of multiple drugs of abuse and/or their metabolites in human urine at the following cutoff levels:
Amphetamine (AMP) Calibrator: d-Amphetamine, Cutoff Level: 500 ng/mL
Barbiturates (BAR) Calibrator: Secobarbital, Cutoff Level: 300 ng/mL
Benzodiazepines (BZO) Calibrator: Oxazepam, Cutoff Level: 300 ng/mL
Buprenorphine (BUP) Calibrator: Buprenorphine, Cutoff Level: 10 ng/mL
Cocaine (COC) Calibrator: Benzoylecgnine, Cutoff Level: 150 ng/mL
EDDP Calibrator: 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Cutoff Level: 300 ng/mL
Ecstasy (MDMA) Calibrator: Methylenedioxymethamphetamine, Cutoff Level: 500 ng/mL
Methamphetamine (MET) Calibrator: d-Methamphetamine, Cutoff Level: 500 ng/mL
Methadone (MTD) Calibrator: Methadone, Cutoff Level: 300 ng/mL
Morphine (MOR300) Calibrator: Morphine, Cutoff Level: 300 ng/mL
Opiates (OPI) Calibrator: Morphine, Cutoff Level: 2,000 ng/mL
Oxycodone (OXY) Calibrator: Oxycodone, Cutoff Level: 100 ng/mL
Phencyclidine (PCP) Calibrator: Phencyclidine, Cutoff Level: 25 ng/mL
Propoxyphene (PPX) Calibrator: Propoxyphene, Cutoff Level: 300 ng/mL
Tricyclic-antidepressant (TCA) Calibrator: Nortriptynine, Cutoff Level: 1,000 ng/mL
Marijuana (THC) Calibrator: 11-nor-Δ9-THC-9-COOH, Cutoff Level: 50 ng/mL

The Advin Multi-Drug Screen Test consists of three formats: a Cassette, a Dip Card and a Cup, which may be configured in any combination of the drug analytes listed in the above table.

Advin Multi-Drug Screen Test is used to obtain a visual, qualitative, preliminary test result for prescription use in point of care sites, laboratory settings and is also intended for workplace and over-the-counter use. The Propoxyphene test strip is not intended for over-the-counter use.

The Advin Multi-Drug Screen Test will yield preliminary positive results when prescription drugs TCA, Barbiturates and Benzodiazepine, Methadone, Buprenorphine and Opiates are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for TCA, Barbiturates and Benzodiazepine in urine.

The Advin Multi-Drug Screen Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry/Mass (LC/MS/MS) and High Performance Liquid Chromatography-(HPLC)-are the-preferred-confirmatory-methods-Glinical-consideration and professional judgment should be applied to any drug of abuse test result, particularly in the evaluation of a preliminary positive test result.

The Advin Multi-Drug Screen Test is a lateral flow immunochromatographic competitive binding assay and is intended for prescription use, CLIA Waived use and OTC use. It is used as in vitro diagnostics to visually and qualitatively detect some of the most common drugs of abuse and/or their metabolites in human urine specimens. The test is based on the principle of competitive binding antigen-antibody immunochemistry. It utilizes anti-drug antibody to selectively detect elevated levels of multi-drugs and/or their metabolites in urine at a specified cutoff for each drug. These visual read tests are performed without the use of an instrument.

A drug-Positive urine specimen will not generate a colored-line in the designated test region, while a drug-Negative urine specimen or a urine specimen containing drug(s) at the concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of urine specimen has been added and membrane wicking has occurred.

Some of the Advin Multi-Drug Screen Test will be sold with either one or two adulteration test strips for the detection of adulterants added to the urine specimen. Each Adulteration strip consists of one to three reagent pads which consist of tests for oxidant, specific gravity, pH, glutaraldehyde, creatinine and nitrite.

Here's a summary of the acceptance criteria and study details for the Advin Multi-Drug Screen Test, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Accuracy" section, which compares the device's results to GC/MS analysis data. For each drug, the device shows an agreement percentage with GC/MS for negative samples and 100% agreement for positive samples above certain thresholds. The specific thresholds for agreement percentage for negative results are:

Additionally, for the lay-user study, the performance criteria were defined as:

• Agreement between lay persons' results and GC/MS analysis results > 99% for concentrations at +/- 50% cutoff levels.
• Agreement between lay persons' results and GC/MS analysis results 65% to 86% for concentrations near the cutoff levels.

The tables for each device format (Cassette, Dipcard, Cup) show that these agreement percentages were met for the tested samples.

2. Sample Size and Data Provenance

Test Set Sample Size:

• Negative Specimens: 40 drug-free urine specimens were collected and tested for each drug.
• Positive Specimens: At least 40 drug-positive urine specimens were obtained for each drug test.
• Lay-Users Study: Over one hundred male and female persons age 18 or older participated. Each level of drug solution (at +/- 50% cutoff and +/- 25% cutoff) was randomly tested with at least 20 replicates by lay persons.

Data Provenance:

• Drug-free urine specimens were collected from presumed non-user volunteers (no specific country mentioned but implied to be the US, given the submission is to the FDA and reference labs are "throughout the United States").
• Drug-positive urine specimens were obtained from reference labs throughout the United States.
• The study is observational/analytical in nature, evaluating device performance against a gold standard method. It can be considered a retrospective analysis of collected urine samples.

3. Number of Experts and Qualifications for Ground Truth

• The text does not explicitly state the number of experts used.
• The ground truth for the test set was established using Gas chromatography/mass spectrometry (GC/MS) and Liquid Chromatography / Mass Spectrometry/Mass (LC/MS/MS for TCA analysis). These are analytical chemistry methods conducted in reference laboratories, implying qualified analytical chemists/technicians were responsible for these measurements. No specific qualifications like "radiologist with 10 years of experience" are mentioned as the "interpreters" of the ground truth for this type of test.

4. Adjudication Method for the Test Set

No explicit adjudication method is mentioned. The comparison was directly between the Advin Multi-Drug Screen Test results and the ground truth established by GC/MS/LC/MS analysis. The "Analysis of Discordant Results" section indicates cases where the device result did not match the GC/MS result, suggesting these were noted rather than adjudicated by another method.

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

There was no MRMC comparative effectiveness study involving human readers with and without AI assistance. This device is a rapid immunoassay that provides a visual, qualitative result, not an AI-powered diagnostic system. However, a "Lay-Users Study" was conducted, demonstrating that lay persons could accurately use the device, which is a form of user performance evaluation.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The "Accuracy" section directly evaluates the performance of the Advin Multi-Drug Screen Test devices (Cassette, Dipcard, Cup) against GC/MS analysis data. This constitutes the algorithm's (immunoassay's) standalone performance without human interpretation being the primary variable. The results are reported as percentage agreements for negative and positive samples.

7. Type of Ground Truth Used

The primary ground truth used was analytical chemistry methods:

• Gas chromatography/mass spectrometry (GC/MS)
• Liquid Chromatography / Mass Spectrometry/Mass (LC/MS/MS) for TCA analysis

8. Sample Size for the Training Set

The document does not mention a training set. This device is an immunoassay, not a machine learning or AI-based diagnostic that would typically require a training set. The studies described are for validation and verification of the device's performance.

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

As no training set is mentioned or applicable for this type of device, this information is not provided in the document.

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