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Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:

Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Propoxyphene, Nortriptyline and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips.

A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Propoxyphene, Nortriptyline and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each drug for the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card in the lay user study can be inferred as achieving at least 85% agreement with GC/MS results for urine samples near the cutoff concentrations (+/- 25% of cutoff). For samples further away from the cutoff (±50%, ±75%, -100% of cutoff), the acceptance criterion appears to be 100% agreement.

Healgen Multi-Drug Urine Test Cup and Dip Card Performance (Lay User Study Data)

The device meets these acceptance criteria, as all reported percentage agreements are at or above the specified thresholds for each drug and concentration level.

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

• Sample Size for Test Set:
  • For each drug analyte tested in the lay user study, the total number of samples evaluated was 300 per format (Cup and Dip Card) across different concentration levels.
  • Specifically, for each drug analyte, the breakdown of samples by concentration was:
    • -100% Cutoff: 20 samples
    • -75% Cutoff: 20 samples
    • -50% Cutoff: 160 samples
    • -25% Cutoff: 20 samples
    • +25% Cutoff: 20 samples
    • +50% Cutoff: 40 samples
    • +75% Cutoff: 20 samples
• Data Provenance: The document does not explicitly state the country of origin of the data. However, as it is a submission to the United States FDA, it is implied that the data is intended for use in the US market. The study utilized "drug free-pooled urine specimens" which were then spiked with drugs, indicating a controlled laboratory setting for sample preparation. The study was conducted at "three intended user sites" with "lay persons," suggesting a prospective evaluation of the device by untrained users.

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

• Number of Experts: Not applicable in the context of this study. The ground truth was not established by human experts interpreting results from the device itself.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an objective chemical analysis method, not a subjective interpretation requiring adjudication among experts. The lay users independently read the results from the test devices.

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

• No, an MRMC comparative effectiveness study was not done. This study focuses on the agreement of the device's results (read by lay users) with a gold standard (GC/MS), rather than comparing the performance of human readers with and without AI assistance. The device itself is a lateral flow immunoassay, not an AI system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone study was done in the sense that the device's performance was compared directly against a definitive analytical method (GC/MS). The lay user study involved individuals interpreting the results of the device directly, without the intervention of an algorithm or AI to assist in that interpretation. The comparison is between the human interpretation of the device and the chemical gold standard, effectively evaluating the standalone performance of the rapid immunoassay device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "The concentrations of the samples were confirmed by GC/MS." GC/MS is a highly accurate and widely accepted method for confirming the presence and concentration of drugs in urine, thus serving as the gold standard.

8. The Sample Size for the Training Set

• The document does not explicitly mention a training set in the context of the lay user study or the development of this specific final product (Healgen Multi-Drug Urine Test Cup/Dip Card). The performance data cited (precision, cut-off, interference, specificity, and method comparison) refers to earlier, individual FDA-cleared predicate devices (K142280, K143187, etc.). It's possible that earlier development and validation work for those predicate devices constituted a "training" or development phase, but details are not provided here. This document primarily describes the validation of the multi-drug format for lay use against a gold standard.

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

• As a training set is not explicitly described for this submission, the method for establishing its ground truth is not provided. However, for similar in-vitro diagnostic devices, the ground truth for training/development (if applicable) would typically be established using validated laboratory reference methods such as GC/MS or LC/MS, similar to the method used for the test set.

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The Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:

Configurations of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes up to a maximum of 14 analytes. Only one cutoff concentration will be included per analyte per device.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized drug levels for Buprenorphine. Nortriptyline or Oxycodone in urine. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. 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.

Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, EDDP, Nortriptyline and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips.

A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, EDDP, Nortriptyline and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

The Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are devices for qualitative and simultaneous detection of various drugs in human urine. The study conducted was a lay user study to verify the device's performance when used by individuals without professional training.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the percentage agreement with GC/MS (Gas Chromatography/Mass Spectrometry) results for different drug concentrations relative to the cutoff level. While no explicit percentage agreement threshold is stated as an "acceptance criteria", standard practice in such studies would expect high agreement for samples at or significantly away from the cutoff. The reported performance shows high agreement, particularly at concentrations of -50% Cutoff, +50% Cutoff, and +75% Cutoff.

Reported Device Performance based on Lay User Study (Agreement with GC/MS):

Note: The specific percentage agreement for -25% and +25% cutoff concentrations varied slightly across different drugs and device types (dip card vs. cup). For instance, Morphine at +25% Cutoff for the dip card and Oxycodone at +25% Cutoff for the cup showed 85% agreement, while others were 90-95%. Oxazepam at -25% Cutoff for the cup also showed 85% agreement.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: For each drug and concentration level (e.g., Methamphetamine at -100% Cutoff), there were between 20 and 170 samples tested. Each device format (Cup and Dip Card) was tested with these samples across all drugs.
  • For -100%, -75%, -25%, +25%, +75% Cutoff, there were 20 samples each.
  • For -50% Cutoff, there were 170 samples.
  • For +50% Cutoff, there were 50 samples.
  • Total samples per drug per device format were 20+20+170+20+20+50+20 = 320 samples.
  • Given there are 14 drugs, the total number of samples processed by lay users for each device format would be approximately 14 drugs * 320 samples/drug = 4480 samples.
• Data Provenance: Not explicitly stated regarding the country of origin of the data. The study was a prospective lay user study where urine samples were prepared and then tested by lay users.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable in the context of human readers for generating ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" was established by an independent laboratory method (GC/MS, see point 7).

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

• MRMC Study: No, this was not a MRMC comparative effectiveness study involving human readers with and without AI assistance. This study focused on the performance of a point-of-care test when interpreted by lay users.

6. Standalone Performance

• Standalone Performance: Yes, the study evaluates the standalone performance of the device (Healgen Multi-Drug Urine Test Cup and Dip Card) when used directly by lay users. The outcome of the device (positive/negative line on the test strip) as interpreted by the lay user is compared against the GC/MS reference standard.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the test set was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug concentration in urine samples.

8. Sample Size for the Training Set

• Training Set Sample Size: The document does not mention a separate training set. The device is a lateral flow immunochromatographic assay, not an AI/ML algorithm that typically requires a training set. The "performance data of precision, cut-off, interference, specificity and method comparison" were reported in predicate device submissions (K142280, K143187, K141647, K140546, K150791, K150096 and K151348), implying these established characteristics during the development of earlier versions.

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

• Ground Truth for Training Set: Not applicable as there is no specific "training set" for the device in the context of AI/ML or expert interpretation. The performance characteristics of the assay would have been established through a series of analytical studies using known concentrations and confirmed methods (like GC/MS) during its development and prior submissions, which serve as the foundation for the assay's expected behavior.

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Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam. Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone in human urine at the cutoff concentrations of:

Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs oxazepan and oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific altemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone, in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, and Oxycodone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

The provided document describes the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card, which are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, and Oxycodone in human urine.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with corresponding performance metrics like sensitivity, specificity, or accuracy for the device as a whole. Instead, it provides the cut-off levels for each drug, which serve as a critical component of the device's performance specification.

The performance characteristics are implied by the statement: "Based on the test principle and acceptable performance characteristics, it's concluded that the Healgen Multi-Drug Urine Test Cup, and Healgen Multi-Drug Urine Test Dip Card are substantially equivalent to the predicates." This suggests that the device's performance was deemed adequate during verification studies. However, specific values for sensitivity, specificity, etc., for the new multi-drug device are not presented.

A table of the specified cut-off levels is provided in the document:

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

The document mentions "verification studies" and "interference studies and a lay-user study" were conducted. However, the exact sample size for the test set is not explicitly provided. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The device is a diagnostic test, not an AI-assisted diagnostic tool, so this type of study is not relevant in this context.

6. Standalone (Algorithm Only) Performance Study

As this is a lateral flow immunoassay device, it does not involve algorithms in the sense of AI or software. Therefore, a standalone (algorithm only) performance study is not applicable and not reported. The device's performance is driven by its biological and chemical components.

7. Type of Ground Truth Used

The document states that a "more specific analytical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method." This indicates that chromatography-mass spectrometry (GC/MS or LC/MS) is the intended gold standard/ground truth for confirming the preliminary results of the device. It is highly probable that similar analytical methods were used to establish the ground truth in the verification studies, although not explicitly stated for the studies performed.

8. Sample Size for the Training Set

The document does not mention or specify a training set sample size. As a lateral flow immunoassay device, it does not typically involve machine learning with separate training and testing datasets in the way an AI diagnostic algorithm would. Its development relies on biochemical optimization and validation.

9. How Ground Truth for the Training Set Was Established

Since there is no "training set" in the context of machine learning, the method for establishing its ground truth is not applicable and not described. Ground truth for assay development would typically involve precisely prepared samples with known drug concentrations, confirmed by highly accurate analytical methods like GC/MS or LC/MS.

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