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Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Healgen Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Healgen Methamphetamine Test is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Healgen Amphetamine Test, Healgen Cocaine Test and Healgen Methamphetamine Test are immunochromatographic assays for Amphetamine, Cocaine and Methamphetamine. Each assay test is a lateral flow system for the qualitative detection of Amphetamine, Benzoylecgonine and Methamphetamine (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

The document describes several tests conducted to prove the performance of the Healgen Amphetamine Test, Healgen Cocaine Test, and Healgen Methamphetamine Test devices.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" through a table or specific thresholds that define success. Instead, it presents performance characteristic studies (precision, cut-off verification, interference, specificity, and comparison to GC/MS) and a lay-user study.

Based on the presented data, the implicit acceptance criteria appear to be:

• Precision: Consistent results across different lots, operators, and concentration levels, especially for samples near the cut-off.
• Cut-off Verification: Accurate classification of samples at or near the specified cut-off concentrations for each drug.
• Interference: No false positive or false negative results due to common interfering substances in urine.
• Specificity: Low or no cross-reactivity with structurally similar but non-target compounds at expected physiological concentrations.
• Method Comparison (with GC/MS): High concordance with GC/MS results, especially for clearly negative and clearly positive samples, with reasonable performance around the cut-off.
• Lay-user usability: High percentage of correct results by lay users and clear instructions for use.

Here's a summary table of the reported device performance for key aspects:

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

• Precision Study (Test Set):
  • Sample Size: For each drug (Amphetamine, Cocaine, Methamphetamine) and each device format (Strip, Cassette, Cup, Dip Card), there were 8 concentration levels tested. For each concentration, tests were performed 2 runs per day for 25 days by 3 different operators, for 3 different lots of devices. This means for one drug and one format: 8 concentrations * 50 results (2 runs/day * 25 days) * 3 lots = 1200 individual tests.
  • Data Provenance: Samples were "negative samples" spiked with drugs to specific concentrations. The drug concentrations were confirmed by GC/MS. The samples were "blind labeled and randomized" by a person not involved in testing. This indicates retrospective preparation of controlled samples, likely performed in a lab setting, not from actual patient samples from a specific country.
• Cut-off Verification Study (Test Set):
  • Sample Size: A total of 150 samples (equally distributed at -50%, -25%, cut-off, +25%, +50% cut-off) were tested. Given 5 concentration levels, this suggests 30 samples per concentration. These were tested using 3 different lots of each device by 3 different operators. So, 150 samples * 3 lots * 3 operators = 1350 individual tests per drug and format.
  • Data Provenance: Samples were prepared by spiking drug in "negative samples." Concentrations confirmed by GC/MS. This indicates retrospective preparation of controlled samples.
• Interference Study (Test Set):
  • Sample Size: Not explicitly stated as a total number of samples, but "Potential interfering substances" were tested by adding them to drug-free urine and target drug urine (+25% cut-off samples). These were tested using three batches of each device for all formats.
  • Data Provenance: Controlled laboratory-prepared urine samples with specified interfering substances and drug concentrations.
• Specificity Study (Test Set):
  • Sample Size: Not explicitly stated as a total number of samples, but drug metabolites and other components were tested using three batches of each device for all formats.
  • Data Provenance: Controlled laboratory-prepared urine samples with specific drug metabolites or related compounds at various concentrations.
• Method Comparison Study (Test Set):
  • Sample Size: For each drug (Amphetamine, Cocaine, Methamphetamine) and each device format, 80 unaltered clinical samples were used (40 negative and 40 positive). These were tested independently by 3 different laboratory assistants (viewers). For one drug and one format: 80 samples * 3 viewers = 240 individual tests.
  • Data Provenance: "unaltered clinical samples." The origin (e.g., country) is not specified. It is reasonable to assume these were retrospective clinical samples as they were "blind labeled."
• Lay-user Study (Test Set):
  • Sample Size: 560 lay persons tested each of the Amphetamine, Cocaine, and Methamphetamine devices, resulting in a total of 1680 individuals who performed the study. Each participant received 1 blind labeled sample and a device.
  • Data Provenance: Urine samples were prepared by spiking drugs into "drug free-pooled urine specimens" to specific concentrations. Concentrations were confirmed by GC/MS. These were retrospectively prepared controlled samples, not actual patient samples. The study participants were "diverse educational and professional backgrounds and ranged in age from 21 to > 50 years."

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

• Precision, Cut-off, Interference, Specificity, and Lay-user Studies: The ground truth for these studies was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard analytical method for drug concentration determination. The individuals performing the GC/MS analysis are typically trained analytical chemists or laboratory technicians, but their specific qualifications are not detailed in the document.
• Method Comparison Study: The ground truth for the 80 unaltered clinical samples was established by GC/MS. As above, specific qualifications of the GC/MS operators are not provided. The device results were then compared to these GC/MS ground truth results.

4. Adjudication method for the test set

• Precision, Cut-off, Interference, Specificity, and Lay-user Studies: No explicit adjudication method is mentioned for the ground truth. The ground truth was set by scientific preparation and GC/MS confirmation of samples. For the device results, multiple operators conducted the tests (3 operators for precision, cut-off; 3 batches for interference/specificity), but it's not stated that their results were adjudicated against each other; they are presented individually or as aggregate performance.
• Method Comparison Study: The document lists results for Viewer A, Viewer B, and Viewer C separately. There is no explicit mention of an adjudication method for comparing interpretations between these viewers or for resolving discordant results by the device itself. The device results from each viewer are directly compared to the GC/MS ground truth.

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

• No, an MRMC comparative effectiveness study was NOT done. This document describes the performance of in-vitro diagnostic test kits (dipstick, cassette, cup formats) for qualitative drug detection by visual interpretation. These are standalone devices, not AI-assisted reading systems.
• Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

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

• Yes, in essence, the "Analytical Performance" section (Precision, Cut-off, Interference, Specificity) and elements of the "Method Comparison Studies" (comparison to GC/MS ground truth) represent standalone performance of the device itself (the immunochromatographic assay reaction and visual line formation), without explicit human 'interpretation' as the primary variable. The visual reading done by operators/viewers in the precision and method comparison studies still involves human interpretation of the color lines.
• However, the Lay-user study specifically evaluated human-in-the-loop performance (lay users interpreting the device according to instructions). Other sections primarily focus on the inherent analytical performance of the test strips/cassettes/cups.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The primary ground truth used throughout these studies is GC/MS (Gas Chromatography/Mass Spectrometry), which is an objective chemical analytical method considered the gold standard for confirming drug concentrations in toxicology.
• For the lay user study, the ground truth was also established by GC/MS for the prepared spiked samples.

8. The sample size for the training set

• The document describes premarket notification studies for an in-vitro diagnostic device. It does not mention a "training set" in the context of machine learning or AI models.
• The device is a laboratory assay; it does not involve algorithms that require training data. The "training" in this context would refer to the development and optimization of the chemical reagents and manufacturing process, which are not detailed as a "training set" in a data science sense.

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

• N/A, as there is no "training set" in the context of data for an AI/ML algorithm.

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