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The QuickScreen™ Barbiturates Test is a rapid, qualitative immunoassay for the detection of Barbiturates in urine. The cutoff concentration for this test is 300 ngdomly This assay is intended for professional use.

QuickScreen Multi Drug Screening Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: Amphetamine; 1000 ng/ml Barbiturates: 300 nq/ml Benzodiazepines: 200 na/ml Cocaine; 300 ng/ml Methadone 300 nq/ml Methamphetamine; 1000 ng/ml Opiates: 2000 ng/ml. Phencyclidine (PCP) 25 ng/ml THC: 50 nq/ml This assay is intended to assist in the prevention of drug abuse

The QuickScreen Barbiturates Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Barbiturates in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. The cut-off concentration will be 300 ng/ml (secobarbital). It is intended for professional use only.

An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. Tests for prescription drugs cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.

Immunoassay for the qualitative detection of Barbiturates in urine

Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Opiates and Methamphetamine in urine

The Phamatech QuickScreen™ Barbiturates Test (Models 9019, 9018) and the QuickScreen Multi Drug Screening Test (Models 9317T and 9187Z) are qualitative immunoassays for the detection of drugs/drug metabolites in urine. This summary addresses the performance of both devices as described in the provided 510(k) summaries.

Acceptance Criteria and Device Performance

The acceptance criteria for the QuickScreen™ Barbiturates Test and the QuickScreen Multi Drug Screening Test are implied through their claims of substantial equivalence to predicate devices and established laboratory methodologies. The performance is assessed by correlation studies against these benchmarks.

For QuickScreen™ Barbiturates Test:

For QuickScreen Multi Drug Screening Test:

Study Details

The information provided covers both the QuickScreen™ Barbiturates Test and the QuickScreen Multi Drug Screening Test. The studies performed were clinical sample correlation studies and blind labeled spiked studies.

1. Sample Size and Data Provenance:

• QuickScreen™ Barbiturates Test: The number of clinical samples used for the correlation study is not specified, only that "clinical specimens" were used. The country of origin for the data is not explicitly stated, but the manufacturer is based in San Diego, California, USA. The studies appear to be retrospective as they involve evaluating existing samples or spiked samples.
• QuickScreen Multi Drug Screening Test: The number of clinical samples, urine samples, and the specific composition of the blinded spiked samples is not specified. Clinical studies were performed at two independent laboratories. The country of origin for the data is not explicitly stated, but the manufacturer is based in San Diego, California, USA. The studies appear to be retrospective as they involve evaluating existing samples or spiked samples.

2. Number of Experts and Qualifications:

• The 510(k) summaries do not specify the number of experts or their qualifications for establishing ground truth for the test sets. The tests are intended for "professional use," and the Multi Drug Screening Test exhibited "excellent overall accuracy (>97%) in the hands of professional users," implying that professionals (likely lab technicians or clinicians) performed the assessments for the device.

3. Adjudication Method:

• The 510(k) summaries do not describe an adjudication method. The clinical sample correlation studies compare the device's results directly against predicate devices (Barbiturates Test) or Behring EMIT II and GC/MS methodology (Multi Drug Screening Test). The "blind labeled spiked study" implies that the labels of the spiked samples were not known to the testers.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was explicitly mentioned. The studies focus on the device's performance against reference methods rather than comparing human reader performance with and without AI assistance. The devices are point-of-care immunoassay tests, not AI-assisted diagnostic tools requiring human interpretation.

5. Standalone Performance (Algorithm Only):

• Yes, performance was evaluated in a standalone manner. These are immunoassay devices that provide a qualitative result directly, without requiring human interpretation other than observing a visual color change. The reported correlations and accuracy reflect the device's direct output.

6. Type of Ground Truth Used:

• QuickScreen™ Barbiturates Test: The ground truth for the clinical sample correlation study was established by predicate devices (e.g., ABMC RapidOne BZD test). For the blind labeled spiked study, the ground truth was based on the known concentrations of barbiturates in the spiked samples.
• QuickScreen Multi Drug Screening Test: The ground truth for the clinical sample correlation study was established by Behring EMIT II and Gas Chromatography/Mass Spectrometry (GC/MS) methodology. For the blind labeled spiked study, the ground truth was based on the known concentrations of the target drugs/metabolites in the spiked samples. GC/MS is widely considered a gold standard for drug confirmation. Expert opinion is also subtly implied through the requirement for professional use and clinical consideration.

7. Sample Size for Training Set:

• The 510(k) summaries do not mention a specific training set or its sample size. These devices are immunoassay tests, not machine learning algorithms that typically require a distinct training set. The development and optimization of such tests usually involve laboratory experiments rather than data-driven training as understood in AI/ML contexts.

8. How Ground Truth for Training Set Was Established:

• As there's no mention of a traditional "training set" in the context of an AI/ML algorithm, this question is not directly applicable. The performance characteristics were evaluated through the clinical sample correlation and blind labeled spiked studies, which served to validate the device's accuracy against established methods and known concentrations.

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