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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%.

OTC Lay-user Accuracy Studies vs. LC/MS Values

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

• Method Comparison (Accuracy) Studies:

  • Sample Size: 176 clinical urine specimens (93 Fentanyl, 83 Tramadol).
  • Data Provenance: Clinical urine specimens, retrospective (since they were confirmed with LC/MS prior to testing with the device). The country of origin is not specified but implied to be within regular clinical testing networks.

• OTC Lay-user Accuracy Studies:

  • Sample Size: 140 intended lay-users for each device format (Dip Card and Cup). Each lay-user received two blind-coded samples.
  • Data Provenance: Urine samples spiked with drugs at various concentrations (0, 50%, 75%, 125%, 150% of cutoff) into drug-free urine pools. This is a prospective study design for evaluating lay-user performance with controlled samples. The samples were confirmed with LC/MS/MS prior to the study. The study was conducted at three intended user sites (Shopping Mall, School, and Hotel), suggesting diverse user demographics.

• Precision/Reproducibility Studies:

  • Sample Size: For each analyte (Norfentanyl and Tramadol), 5 replicates at 6 concentration levels (0%, -50%, -25%, Cutoff, +25%, +50% of the cutoff) were tested with 3 lots of each device format (Cup and Dip Card) by 3 operators over 5 consecutive days.
    • This totals to 5 replicates * 6 concentrations * 3 lots * 3 operators = 270 tests per analyte per device format.
    • Thus, for FYL Dip Card: 270 samples. FYL Cup Test: 270 samples. TML Dip Card: 270 samples. TML Cup Test: 270 samples.

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

• Method Comparison (Accuracy) Studies: The ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is a highly accurate analytical chemistry technique considered the "gold standard" for drug concentration determination. The text states: "Each specimen was confirmed with LC/MS assay with the value assignment." and "The accuracy of the Chemtrue® Test devices were evaluated against ... clinical urine specimens. Each specimen was confirmed with LC/MS assay with the value assignment."

  • This is an instrument-based determination, not typically requiring human expert consensus in the same way as, for example, image interpretation. The "experts" here are the drug analysts who performed the LC/MS analysis and validated the results.
  • The study mentions "One drug analyst with one set of blind code in one device format - Dip Card / Cup were tested by one operator." This refers to the operators performing the rapid immunoassay tests, not the LC/MS ground truth determination.

• OTC Lay-user Accuracy Studies: The ground truth was established by LC/MS/MS ("Concentrations By LC-MS/MS (ng/mL)") of the spiked urine samples. As above, this is an instrument-based method.

• Precision/Reproducibility Studies: The ground truth for the spiked urine controls was defined by their known concentrations, which were "LC/MS confirmed concentrations."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• For the Method Comparison (Accuracy) Studies and OTC Lay-user Accuracy Studies, no human adjudication method (like 2+1 or 3+1) is described for establishing the ground truth. The ground truth (LC/MS or LC/MS/MS results) is considered definitive. The rapid immunoassay device results are compared directly to this definitive ground truth.
  • For the actual reading of the rapid immunoassay devices, 4 operators performed the tests for the method comparison study, but their readings were individual comparisons to the LC/MS reference, not adjudicated against each other.
  • For the OTC study, "intended lay-users" performed the interpretation, and their results were compared to the LC/MS/MS values.

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 MRMC comparative effectiveness study was done.
• This device is a rapid lateral flow immunoassay for drug detection, not an AI-powered diagnostic system requiring human interpretation or assistance from AI, so this type of study is not applicable. The immunoassay itself provides a visual result (line/no line) that lay users interpret.

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

• This question is not applicable as the device is a rapid lateral flow immunoassay, which is a standalone point-of-care test, not an algorithm. The "performance" is the chemical reaction and visual read-out of the test strip/cup. The "human-in-the-loop" is the user interpreting the visual result. However, the studies evaluating its performance involved human users (operators for method comparison, lay-users for OTC study) interpreting the visual output.

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

• The primary ground truth used for all performance studies (accuracy, precision, OTC accuracy) was analytical confirmation by LC/MS or LC/MS/MS. This is a highly precise and quantitative laboratory method considered definitive for identifying and quantifying drug metabolites in urine.

8. The Sample Size for the Training Set

• No training set is described because this device is a rapid lateral flow immunoassay, not a machine learning or AI-based algorithm that requires a training set. The device operates based on chemical reactions and antigen-antibody binding.

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

• This question is not applicable as there is no training set for this type of device.

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