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The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The single or multi-test cups can consist of up to eighteen (18) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Healgen® Accurate Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs

This drug test cup may contain any combination of the drug tests listed in the table above.

This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Healgen® Accurate Home Muti-Drug Urine Test Cup and Healgen® Accurate Muti-Drug Urine Drug Screen Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

Acceptance Criteria and Device Performance for Healgen® Accurate Multi-Drug Urine Drug Screen Cup

This document outlines the acceptance criteria and the evidence provided to demonstrate that the Healgen® Accurate Multi-Drug Urine Drug Screen Cup meets these criteria. The information is extracted from the provided FDA 510(k) summary (K243365).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this qualitative immunoassay are primarily demonstrated through a combination of precision, analytical specificity/interference, and a method comparison study. The precision study evaluates the device's ability to consistently produce correct results at various concentrations relative to the cutoff, while the method comparison study assesses its agreement with a gold standard (LC-MS/MS) using clinical samples. The layperson study demonstrates ease of use for over-the-counter applications.

• 100% agreement for concentrations at -100%, -75%, -50%, +50%, +75%, and +100% cutoff (e.g., 0-/50+ or 50-/0+ indicating no false negatives or positives respectively).
• At the cutoff concentration, results consistently showed a mix of positive and negative interpretations, typically near 50%/50% (e.g., 23-/27+, 25-/25+), demonstrating sensitivity around the cutoff.
• At -25% cutoff, the device predominantly showed negative results (e.g., 50-/0+ or 49-/1+), with a few false positives.
• At +25% cutoff, the device predominantly showed positive results (e.g., 0-/50+ or 1-/49+), with a few false negatives.
  This indicates good precision around the cutoff with expected variability at borderline concentrations. |
  | Analytical Specificity | No significant cross-reactivity with commonly encountered substances (drug metabolites, prescription medications, endogenous compounds) at relevant concentrations, and no interference from variations in pH and specific gravity within a physiological range. | Diverse lists of compounds were tested for cross-reactivity. The results show that:
• Many cross-reacting compounds are identified with their minimum concentration needed to yield a positive result and their % Cross-Reactivity (e.g., Hydroxyamphetamine with AMP 1000, Amobarbital with BAR 300).
• Numerous compounds showed no detection or were negative at high concentrations (e.g., 100,000 ng/mL), indicating no cross-reactivity for those substances.
• pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 were demonstrated to not affect the assay results. |
  | Method Comparison | A high degree of concordance between the device's qualitative results and confirmatory Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) results for clinical urine samples, particularly for samples at or near the cutoff. | For each drug and its cutoff configuration:
• 100% agreement was observed for drug-free samples and "low negative" samples (less than -50% of cutoff).
• 100% agreement was primarily observed for "high positive" samples (greater than +50% of cutoff).
• For "near cutoff negative" (between -50% and cutoff) and "near cutoff positive" (between cutoff and +50%) samples, there was expected variability, with some samples interpreted differently by the device compared to LC-MS/MS, indicating the device's expected performance around the cutoff. The discordant results table details specific samples where device results differed from LC-MS/MS. Generally, the majority of samples near the cutoff were correctly identified by the device. |
  | Lay Person Usability | The device should be easy to understand and use by laypersons as indicated by a high agreement in understanding instructions and performance on prepared samples across different drug classes. A reading level analysis of the instructions for use should demonstrate appropriate readability. | A study with 280 laypersons (mix of male/female, aged 21 to >50, diverse backgrounds) demonstrated:
• 100% agreement for interpretation of drug-free and concentrations at -100%, -75%, -50% below cutoff.
• 100% agreement for concentrations at +50% and +75% above cutoff.
• Expected variability in agreement around the -25% and +25% cutoff concentrations, mostly ranging from 90% to 95%.
• All participants indicated the instructions were easy to understand and follow.
• The Flesch-Kincaid reading analysis yielded a Grade Level of 7, which is suitable for layperson use. |
  | Stability | The device should maintain its performance characteristics for a specified duration under defined storage conditions. | The device is stable at 2-30°C for 36 months based on real-time stability studies. |

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

Precision/Reproducibility Study:

• Sample Size: For each drug and each concentration level (total 9 levels per drug), 50 individual tests were performed (2 runs per day for 25 days). Given there are 17 distinct drug analytes, this amounts to 17 drugs * 9 concentrations * 50 tests/concentration = 7,650 tests.
• Data Provenance: Samples were prepared by spiking target drugs into drug-free urine samples. These samples were likely prepared in a laboratory setting, making the data provenance prospective and controlled. The document does not specify a country of origin for the samples/urine, but the study was conducted "in-house."

Method Comparison Study:

• Sample Size: For each drug, 80 unaltered urine clinical samples were used. This consisted of 40 negative and 40 positive samples. Given there are 17 distinct drug analytes, this amounts to 17 drugs * 80 samples/drug = 1,360 total clinical samples tested across all drugs.
• Data Provenance: Unaltered clinical urine samples. The document does not specify the country of origin but states the study was performed "in-house." The nature of "unaltered clinical samples" suggests these were collected from patients, and their retrospective or prospective nature is not explicitly stated, though being "blind labeled" for comparison suggests they were handled specifically for this study.

Lay Person Study:

• Sample Size: 280 lay persons participated. Urine samples were prepared at 7 concentration levels (-100%, +/-75%, +/-50%, +/-25% of cutoff). Each participant tested 1 blind labeled sample. While it states urine samples were prepared at 7 concentrations, the agreement tables show 7 concentrations and 20 tests per concentration for each drug. If we assume each of the 280 participants tested one sample for one drug, the sample sizes per concentration shown in the table (20 tests) indicate that multiple participants contributed data for each drug and concentration, but a single participant did not test all drugs or all concentrations.
• Data Provenance: Urine samples were prepared by spiking drugs into drug-free pooled urine specimens. The samples were prepared in a laboratory environment, indicating prospective and controlled data provenance. The lay persons were recruited for the study, making their involvement prospective. The study was performed at "three intended user sites."

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

Precision/Reproducibility Study:

• Ground Truth: The "ground truth" for the spiked samples was established by the known concentrations of the spiked drugs, which were confirmed by LC-MS/MS.
• Experts/Qualifications: The document states that "Each drug concentration was confirmed by LC-MS/MS." LC-MS/MS is a highly accurate analytical method, and while specific "experts" (e.g., toxicologists, clinical chemists) are not explicitly named, the use of this method implies analysis by qualified laboratory personnel specializing in mass spectrometry. "One operator per lot" (for 3 lots) performed the tests on the device, but the LC-MS/MS confirmation implies separate, expert analysis for ground truth.

Method Comparison Study:

• Ground Truth: The ground truth for the clinical samples was established by LC-MS/MS results.
• Experts/Qualifications: Similar to the precision study, the ground truth was determined by LC-MS/MS, implying analysis by qualified laboratory professionals. No specific number or qualification of "experts" is provided beyond the analytical method itself.

Lay Person Study:

• Ground Truth: The "ground truth" for the spiked samples was established by the known concentrations of the spiked drugs, which were confirmed by LC-MS/MS.
• Experts/Qualifications: As above, the ground truth was derived from LC-MS/MS analysis, indicating reliance on qualified laboratory personnel.

4. Adjudication Method for the Test Set

Precision/Reproducibility Study:

• Adjudication Method: Not applicable in the traditional sense of expert consensus. The ground truth was based on the quantitative LC-MS/MS results of the spiked samples. The device's qualitative results were compared against these known concentrations relative to the cutoff. Discrepancies were noted directly.

Method Comparison Study:

• Adjudication Method: Not applicable/Not explicitly stated as an adjudication process involving multiple human readers. The device results were directly compared to the LC-MS/MS results, which served as the definitive "true" value (ground truth). The tables show the device's output (positive/negative) versus the LC-MS/MS quantification, which then categorizes samples as drug-free, low negative, near cutoff negative, near cutoff positive, or high positive.

Lay Person Study:

• Adjudication Method: Not applicable in terms of expert consensus. The laypersons' interpretations of the device results were compared against the established ground truth (LC-MS/MS confirmed concentrations of spiked samples). The study aimed to assess if laypersons could correctly interpret the device results against this objective ground truth, not for them to establish ground truth or adjudicate.

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

No, an MRMC comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance, as this is an in-vitro diagnostic device (a test cup) not an AI-powered diagnostic imaging or interpretation system. The "operators" in the method comparison study refer to individuals performing the device test, not medical interpreters assisted by AI. The "lay person study" evaluated if laypersons could correctly interpret the device, not an AI system.

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

This is an in-vitro diagnostic (IVD) device (a lateral flow immunoassay test cup), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable in the typical sense for AI/software devices. The device itself provides a visual qualitative result (lines appearing or not appearing), which then requires human observation and interpretation. The performance characteristics described (precision, specificity, method comparison) are inherently "standalone" in that they assess the device's ability to produce correct visual results, which a human then reads. The layperson study specifically evaluates the human (layperson) interpretation of these visual results.

7. The Type of Ground Truth Used

The primary type of ground truth used across all analytical performance studies (Precision, Analytical Specificity, Method Comparison, and Lay Person Study where applicable) is Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS) and their tandem mass-spectrometer versions (LC-MS/MS).

These are considered confirmatory analytical methods and are widely accepted as the gold standard for quantitative drug detection in toxicology.

8. The Sample Size for the Training Set

As this device is a lateral flow immunoassay (a chemical/biological test kit), and not an AI/machine learning algorithm, there is no "training set" in the computational sense. The device's performance is based on its inherent physical and chemical properties and reagent formulations, which are developed and optimized through laboratory research and development, rather than machine learning training.

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

Since there is no "training set" for this type of device, this question is not applicable. The development and optimization of the immunoassay undoubtedly involved extensive experimentation with samples of known drug concentrations, likely confirmed by GC-MS/LC-MS, but this is part of the product's research and development process, not analogous to establishing ground truth for a machine learning training set.

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