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The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene , Tramadol and Trivyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows:

The multi test panels can consist of any analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants.

The Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The Chemtrue® Drug Screen Fentany! / Tramadol Dip Card Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The test is not intended to differentiate between drugs of abuse and prescription use of Fentanyl/ Tramadol. The test is for in vitro diagnostic use only.

The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. It is an in vitro diagnostic device. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The Chemtrue® Drug Screen Fentany1 / Tramadol Cup Test detects and is calibrated against norfentany1, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.

The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to the drug test result, particularly when preliminary positive result is indicated.

The test is not intended to differentiate between drugs of abuse and prescription use of Fentany/ Tramadol. The test is for in vitro diagnostic use only.

The Chemtrue® Multi-Panel Drug Screen Dip Card Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentany, Marijuana, Methadone, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device.

The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Benzodiazepines, Antidepressants.

The Chemtrue® Multi-Panel Drug Screen Cup Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device.

The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Tricyclic Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Antidepressants.

The Chemtrue® Drug Screen Tests are colloidal gold-based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.

The provided text describes the performance characteristics of the Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test and Dip Card Test. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative immunoassay diagnostic devices typically involve high levels of agreement with a reference method, especially around the cutoff concentration. While explicit acceptance criteria ("Pass/Fail" thresholds) are not directly stated in the provided text, the reported performance demonstrates very high agreement.

Note: The tables below focus on the Fentanyl (FYL) and Tramadol (TML) tests as these are the new additions being evaluated in this submission. Previous analytes were cleared under older 510(k)s. The percentages under "Reported Device Performance" are calculated from the provided raw counts.

Method Comparison (Accuracy) Studies vs. LC/MS Reference Method

The agreement is calculated as (Number of correct results / Total number of samples in that category) * 100%.

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The Chemitrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunossays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The multi test panels can consist of up to fourteen (14) of the above issed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GCMS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodizepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

The Chemtrue® Drug Screen Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.

Acceptance Criteria and Device Performance for Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests

This document describes the acceptance criteria and the study that demonstrates the Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests meet these criteria. The device is a rapid lateral flow immunoassay for the qualitative detection of various drugs of abuse in human urine, intended for prescription and Over-The-Counter (OTC) use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are implicitly demonstrated through the performance characteristics presented in the 510(k) summary. These include:

• Precision (Reproducibility): Consistent results at and around the cut-off concentrations across different operators and lots. The exact acceptance percentage for concordance at cut-off is not explicitly stated as a numerical criterion but is demonstrated by the reported distribution of positive/negative results.
• Specificity (Cross-Reactivity): Detect the target analytes and related compounds at specified concentrations, while exhibiting minimal cross-reactivity with non-target substances. Acceptance is qualitative based on the reported cross-reactivity percentages.
• Interference: No interference from common endogenous compounds or non-structurally related compounds. Acceptance is qualitative, showing "no interference" for a wide range of substances at tested concentrations.
• Effect of Urine pH and Specific Gravity: Test performance should not be affected by variations in urine pH and specific gravity within specified ranges. Acceptance is demonstrated by stating these factors "do not affect the test performance."
• Stability: Maintain performance over a specified shelf-life. Acceptance is a 2-year shelf life at 2°C to 30°C.
• Accuracy (Method Comparison): High agreement with a confirmed reference method (GC/MS). The acceptance criterion for accuracy is ≥ 99% agreement between the Chemtrue® Drug Screen test device and GC/MS values.
• Lay-user Accuracy and Usability (for OTC): High accuracy when performed by lay-users and ease of understanding instructions. The acceptance criterion is demonstrated by ≥ 99% agreement with GC/MS values for lay-user studies and ≥ 96% of lay users easily following instructions.

Below is a summary of the key performance criteria and the reported device performance. Note that for precision and cross-reactivity, specific numerical acceptance thresholds were not explicitly stated as distinct criteria, but the reported performance data in the tables indicate successful demonstration of these characteristics.

Table 1: Acceptance Criteria and Reported Device Performance

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

The document does not explicitly delineate a "test set" in the context of the training/testing split common in AI/ML studies, as this device is a lateral flow immunoassay. Instead, it refers to various validation studies.

• Precision (Reproducibility) Studies:
  • Sample Size: 30 samples per concentration level (Negative, 50% of cutoff, 75% of cutoff, Cutoff, 125% of cutoff, 150% of cutoff) for each analyte and device format. This equates to 180 samples per analyte/format combination (e.g., AMP Dip Card Test: Cutoff: 300 ng/mL used 180 samples).
  • Data Provenance: Not specified, but the samples were "GC/MS confirmed drug spiked urine controls." This implies controlled laboratory generation rather than real clinical samples. No country of origin is mentioned. These are prospective, controlled experiments due to the spiked nature.
• Specificity Studies:
  • Sample Size: Not explicitly stated as a number of "samples." Various related compounds were tested for cross-reactivity at different concentrations, and 103 potential interferents were tested at a concentration of 100 µg/mL at ±25% of the drug cut-off concentrations.
  • Data Provenance: Not specified, likely laboratory-generated samples with controlled spiking of compounds. Prospective.
• Interference Studies:
  • Sample Size: 103 potential interferents tested. Each was tested with "one lot each of the test device format." The implied sample count would be (number of interferents) * (number of device formats).
  • Data Provenance: Laboratory-generated, spiked samples. Prospective.
• Effect of Urine pH and Specific Gravity Studies:
  • Sample Size: Not explicitly stated, but tests were performed within specified pH and SG ranges at ±25% of the drug cut-off concentrations.
  • Data Provenance: Laboratory-generated, controlled urine samples. Prospective.
• Accuracy (Method Comparison) Studies:
  • Sample Size: "On average of 85 clinical specimens for each drug test and a total of 685 samples were tested" for the analytes specifically included in this submission (AMP300/500, BAR200/BZO200, COC150, MET300/500 and PPX).
  • Data Provenance: "blind-labeled clinical specimen correlation study." This indicates real human urine samples, but the country of origin is not specified. These are retrospective analyses as they compare the device's results to pre-existing or independently confirmed GC/MS values.
• OTC Lay-user Accuracy Studies:
  • Sample Size: "One hundred (130) intended lay-users participated in the evaluation for each of the device format (Dip Card and Cup)." The number of tests performed is much higher, as each lay-user was given "up to two (2) random blind labeled samples" with concentrations covering negative, 50%, 75%, 125%, 150%, and 200% of the cutoff.
  • Data Provenance: "GC/MS confirmed urine samples," which were "spiking drugs into drug-free urine pool." This suggests laboratory-controlled, spiked samples rather than true "clinical" samples from drug users. Prospective experiment.

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

• For Precision, Specificity, Interference, pH/SG, OTC Lay-user Studies: The ground truth was established by GC/MS confirmation of drug-spiked urine samples. This method is considered the gold standard for drug detection and quantification in urine. Therefore, the "experts" are the technicians/analysts operating the GC/MS equipment, whose qualifications are implicitly high-level laboratory personnel but not explicitly stated (e.g., clinical chemists, toxicologists).
• For Accuracy (Method Comparison) Studies: The ground truth was also established by GC/MS values. These were "blind-labeled clinical specimen" samples. Again, the experts are the GC/MS laboratory personnel. The document states, "Three operators performed the testing," but this refers to the Chemtrue device operators, not necessarily the GC/MS operators who established ground truth.

4. Adjudication Method for the Test Set

• For Precision Studies: The ground truth for the spiked samples was known. Qualitative results (+/-) from the device were compared against the expected positive/negative based on the known concentration relative to the cutoff. Discordant results are implicitly handled by the quantitative reporting in the tables (e.g., at cutoff, some were positive, some negative, reflecting the expected variability around the cutoff).
• For Accuracy (Method Comparison) Studies: The ground truth was the GC/MS value. This method serves as the definitive reference, so no adjudication among multiple experts for ground truth was performed; it was a direct comparison to the GC/MS result. The results describe "discordant results" where the device's reading didn't match the GC/MS, and these were "confirmed at the drug cutoff level with the GC/MS concentrations," which is a further verification against the gold standard.
• For OTC Lay-user Accuracy Studies: Similar to the accuracy studies, the ground truth was the GC/MS values from the spiked samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. MRMC studies are typically used to assess the improvement in human reader performance (e.g., radiologists interpreting images) with and without AI assistance. The Chemtrue device is a rapid diagnostic test (lateral flow immunoassay) that provides a direct qualitative result, not an AI system designed to assist human interpretation of complex data. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.

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

Yes, the device essentially operates in a standalone manner. The Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests are standalone devices that generate a qualitative (positive/negative) result without human intervention in the result generation process itself. Humans are "in the loop" for running the test and interpreting the visual lines, but the device's chemical reactions provide the "algorithm's" output.

The validation studies (precision, specificity, interference, pH/SG, and the majority of the accuracy studies) demonstrate this standalone performance. The "OTC Lay-user Accuracy Studies" did involve human interpretation of the visual lines by lay-users, evaluating their ability to correctly use and interpret the standalone device.

7. The Type of Ground Truth Used

The primary ground truth used throughout the studies is Gas Chromatography / Mass Spectrometry (GC/MS). For all accuracy studies, spiked samples and clinical specimens were confirmed by GC/MS. This is explicitly stated: "GC/MS or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods." Given the context of drug screening devices, GC/MS is widely considered the definitive reference method for identifying and quantifying drugs and their metabolites in biological matrices.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to traditional lateral flow immunoassay devices like the Chemtrue Multi-Panel Drug Screen tests. These are not machine learning or AI models that require training data to develop their "algorithm." Their mechanism is based on specific antigen-antibody reactions. Therefore, there is no "training set" in the computational sense. The device's components (antibodies, drug-protein conjugates) are developed and optimized through laboratory research and development, but this is a different process than "training" a dataset.

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

As explained in point 8, there is no "training set" in the context of this device. The development of the assay relies on established biochemical principles and extensive R&D to select and optimize antibodies and reagents. The "ground truth" for the development and optimization of the assay components would involve controlled laboratory experiments using known concentrations of analytes and interferents, confirmed by reference methods like GC/MS, to ensure the assay's sensitivity and specificity are appropriate to achieve the desired cut-offs. This is part of the extensive biochemical and quality control processes inherent in developing such diagnostic tests.

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