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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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The Chemtrue® Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Morphine 300, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The Chemtrue® Drug Screen Cup Tests panel can consist of any combination of the above listed drug analytes.

The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical method 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 and Tricyclic Antidepressants. There are no uniformly recognized cutoff concentration levels for these drugs in urine.

The Chemtrue Drug Screen Cup Tests with OPI 2000 are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The Chemtrue Drug Screen Cup Tests with OPI 2000 panel can consist of any combination of the above listed drug analytes.

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 (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 Benzodizzepines, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cutoff concentration levels for these drugs in urine.

The Chemtrue® Drug Screen Cup 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 the Cup format, as indicated by the test name.

The provided document describes the performance characteristics of the Chemtrue® Drug Screen Cup Tests and Chemtrue® Drug Screen Cup Tests with OPI 2000.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a pass/fail threshold. Instead, it presents the results of reproducibility, specificity, interference, and method comparison studies. The performance is reported in terms of agreement with GC/MS (reference method) and the percentage of accurate results at various concentrations (negative, 50%, 75%, 125%, 150% of cutoff). For the purpose of this response, "reported device performance" will be directly extracted from the provided tables.

Acceptance Criteria (Implied) and Reported Device Performance for Method Comparison (Accuracy) Study:

The document implies an acceptance criterion for accuracy based on the "Agreement" percentage. For most analytes, the agreement with the GC/MS reference method is 98% or 100%. For discordant results, it is noted that these were confirmed at the drug cutoff level.

Acceptance Criteria (Implied) and Reported Device Performance for OTC Lay-user Accuracy and Usability Studies:

The implied acceptance criterion here is 100% agreement for all drug concentrations (No Drug Present, 50% of cutoff, 75% of cutoff, 125% of cutoff, 150% of cutoff). For all analytes except THC, 100% agreement was reported across all concentration levels tested. THC showed 90% agreement at 75% of cutoff.

| Analyte | Cutoff (ng/mL) | Agreement (No Drug present) | Agreement (50% cutoff) | Agreement (75% cutoff) | Agreement (125% cutoff) | Agreement (150% cutoff) |
|---|---|---|---|---|---|
| AMP | 1000 | 100% | 100% | 100% | 100% | 100% |
| BAR | 300 | 100% | 100% | 100% | 100% | 100% |
| BZO | 300 | 100% | 100% | 100% | 100% | 100% |
| BUP | 10 | 100% | 100% | 100% | 100% | 100% |
| COC | 300 | 100% | 100% | 100% | 100% | 100% |
| MDMA | 500 | 100% | 100% | 100% | 100% | 100% |
| MET | 1000 | 100% | 100% | 100% | 100% | 100% |
| MTD | 300 | 100% | 100% | 100% | 100% | 100% |
| MOR | 300 | 100% | 100% | 100% | 100% | 100% |
| OPI | 2000 | 100% | 100% | 100% | 100% | 100% |
| OXY | 100 | 100% | 100% | 100% | 100% | 100% |
| PCP | 25 | 100% | 100% | 100% | 100% | 100% |
| TCA | 1000 | 100% | 100% | 100% | 100% | 100% |
| THC | 50 | 100% | 100% | 90% | 100% | 100% |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Method Comparison Studies (Accuracy Study):

  • Sample Size: "On average of 85 clinical specimens for each drug test and a total of 586 samples were tested."
  • Data Provenance: The document states "blind-labeled clinical specimen correlation study". It does not specify the country of origin of the data or explicitly state if it was retrospective or prospective, but the use of "clinical specimens" suggests these were real-world samples.

• Reproducibility (Precision) Studies:

  • Sample Size: For each analyte and concentration level, 30 devices were tested (3 operators * 3 lots * 10 replicates for each level of Negative, 50%, 75%, Cutoff, 125%, 150% of the cutoff). The tables show n=210 for Negative concentration and n=30 for each of the other concentration levels (50%, 75%, Cutoff, 125%, 150% of cutoff) over 10 non-consecutive days.
  • Data Provenance: The study used "GC/MS confirmed drug spiked urine controls." This indicates artificially prepared samples by spiking drugs into drug-free urine, not clinical specimens. The location or type of institution where this was performed is not specified.

• OTC Lay-user Accuracy and Usability Studies:

  • Sample Size: 100 intended lay-users participated.
  • Data Provenance: "GC/MS confirmed urine samples" were used. These samples were artificially prepared by "spiking drugs into drug-free urine pool" and aliquoted into individual blind-labeled containers. The study was conducted at "three (3) intended user sites," implying it was conducted in a real-world or simulated real-world setting for OTC use, but the origin of the drug-free urine or spiking drugs is not detailed.

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

The ground truth for all performance studies (reproducibility, method comparison, and OTC lay-user accuracy) was established using Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) as the preferred confirmatory methods.

GC/MS and LC/MS are analytical chemistry techniques that provide definitive identification and quantification of substances. Therefore, the "ground truth" is based on the results of these highly accurate chemical methods, rather than human expert interpretation of images or clinical findings. The expertise implicitly lies in the technicians and analytical instruments performing the GC/MS/LC/MS analysis. No specific "number of experts" or their "qualifications" like radiologists with X years of experience are applicable here, as it's a lab-based chemical assay validation.

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

The concept of a "2+1" or "3+1" adjudication method is typically used in studies where multiple human readers interpret results and a consensus or tie-breaker is needed, especially in imaging studies.

In this context, the adjudication method is "none" for human readers. Any "adjudication" between the device's results and the ground truth was done by comparing the device's qualitative positive/negative result against the quantitative GC/MS/LC/MS cut-off value. If there was a discrepancy (discordant result), the GC/MS result was considered the definitive truth. The "blind-labeled clinical specimen correlation study" implies that the device results were compared after the GC/MS truth was known, or at least independently, to determine agreement.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

This type of study is relevant for evaluating human performance improvements with AI assistance, typically in diagnostic imaging where human readers interpret and classify cases. The Chemtrue® Drug Screen Cup Tests are in vitro diagnostic devices (qualitative immunoassays) for drug detection in urine, interpreted visually by a single user. There is no "AI assistance" involved in the interpretation process described in this document, nor is there a cohort of human readers making independent diagnostic judgments that would then be compared.

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

Yes, a standalone performance study was done in essence. The "Reproducibility (Precision) Studies," "Specificity Study," and "Interference" studies examine the intrinsic performance of the device (immunoassay) itself under controlled conditions and against known reference methods (GC/MS). The tables showing detection rates at various concentrations and cross-reactivity are direct measures of the device's standalone performance.

The "Method Comparison Studies" (Accuracy study, section H.5) also evaluate the device's performance against the GC/MS reference method. While "three operators performed the testing," their role was to visually interpret the test lines, which is a direct readout of the device's chemical reaction. The accuracy is reported as the device's performance against the gold standard, not the operators' modified performance.

The "OTC Lay-user Accuracy and Usability Studies" (section H.6) assess "lay-user accuracy," which means how accurately un-trained individuals could read and interpret the device standalone results. This is still a standalone performance assessment of the device, albeit under user-influenced conditions.

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

The primary type of ground truth used for performance evaluation was Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS). These are highly accurate and definitive analytical chemistry methods for identifying and quantifying substances in a sample.

• For reproducibility studies, GC/MS confirmed drug spiked urine controls were used.
• For method comparison studies, the device was compared to the GC/MS Reference Method using blind-labeled clinical specimens.
• For OTC lay-user studies, GC/MS confirmed urine samples (spiked into drug-free urine pool) were used.

8. The sample size for the training set

The document describes the validation studies for the device but does not specify or mention a "training set" in the context of machine learning or AI algorithm development. The device is a lateral flow immunoassay, which relies on chemical reactions and visual interpretation, not on trained algorithms that require a separate training dataset.

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

As there is no mention of a "training set" for an AI or machine learning algorithm in this document (the device is a qualitativeunoassay), this question is not applicable. The ground truth for the device's validation was established using GC/MS/LC/MS as detailed above.

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Chemtrue® Multi-Panel DOA Dip Card Tests:
The Chemtrue® Multi-Panel DOA Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows:

The Chemtrue® Multi-Panel DOA Dip Card Tests panel can consist of any combination of the above listed drug analytes. 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 (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the prefered 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, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests:
The Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines. Barbiturates, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The Chemrue® Multi-Panel DOA Dip Card with OP1 2000 Tests can consist of any combination of the above listed drug analytes. 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 Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

The Chemtrue® DOA 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 the formats of dip card, cup, or cassette, as indicated by the test name.

The provided document, K142580, describes the substantial equivalence determination for the Chemtrue® Multi-Panel DOA Dip Card Tests. It references previous 510(k) clearances (K102203, K111322, K121339, and K123080) for the individual drug analytes, stating that the test strips, sample matrix, test format, and cut-off concentrations for these analytes are identical to those previously cleared. Therefore, the performance characteristics and studies for the individual analyte tests are found in those referenced 510(k) submissions.

This document focuses on the new combination of these previously cleared test strips into multi-panel kits and confirms that verification and validation activities were conducted for this combination.

Here's an analysis of the acceptance criteria and study information provided (or inferred from the context of a 510(k) summary for a diagnostic device):

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) references prior clearances for the individual analytes, the general acceptance criteria for such qualitative tests involve achieving a certain level of agreement (e.g., sensitivity and specificity) with a validated reference method (like GC/MS or LC/MS) at and around the cut-off concentration. The document states that the performance characteristics (precision, specificity, interference, method comparison, stability, and lay-user study information) for each individual drug analyte were established in the predicate 510(k)s.

The "reported device performance" specifically mentioned in this document relates to the intended use and cut-off concentrations, which are considered to be "Same" as the predicate devices.

• Amphetamine: 1000 ng/mL
• Cocaine: 300 ng/mL
• Methamphetamine: 1000 ng/mL
• Morphine: 300 ng/mL
• Phencyclidine: 25 ng/mL
• Marijuana: 50 ng/mL
• Benzodiazepines: 300 ng/mL
• Barbiturates: 300 ng/mL
• Ecstasy: 500 ng/mL
• Methadone: 300 ng/mL
• Oxycodone: 100 ng/mL
  Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests:
• Amphetamine: 1000 ng/mL
• Cocaine: 300 ng/mL
• Methamphetamine: 1000 ng/mL
• Opiates: 2000 ng/mL
• Phencyclidine: 25 ng/mL
• Marijuana: 50 ng/mL
• Benzodiazepines: 300 ng/mL
• Barbiturates: 300 ng/mL
• Ecstasy: 500 ng/mL
• Methadone: 300 ng/mL
• Oxycodone: 100 ng/mL
  All cut-offs are "Same" as predicate devices. |
  | Maintain performance characteristics (precision, specificity, interference, stability, method comparison, lay-user accuracy) as previously cleared devices. | Stated that "Test strips, sample matrix, test format, and cut-off concentrations for these drugs of abuse analytes are identical to those cleared under K102203, K111322, K121339, and K123080. See K102203, K111322, K121339, and K123080 for additional precision, specificity, interference, method comparison, stability and lay-user study information." |
  | Verification and validation of the multi-panel combination. | "Verification and validation activities were conducted to support combining the test strips to create the multi-panel candidate devices, including interference studies and usability testing." Specific results not detailed in this document. |
  | Intended Use (Prescription and OTC) | "Same" as predicate devices. |

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

• Sample Size for Test Set: Not explicitly stated in this document for the overall multi-panel device. The document defers to prior 510(k)s (K102203, K111322, K121339, and K123080) for the individual analyte performance. For a typical qualitative DOA test submission, sample sizes would often involve testing a range of concentrations around the cut-off (e.g., -25%, -50%, +25%, +50% of cut-off) with multiple replicates (e.g., 20 or more) for each analyte, across multiple lots.
• Data Provenance: Not explicitly stated in this document. Given it's a submission to the FDA, it's generally expected that studies would be conducted in a way that is acceptable to the FDA, likely involving studies in the US or under internationally recognized standards. The document does not specify if the data was retrospective or prospective.

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

• This information is not provided in the K142580 document. For diagnostic tests of this nature, the "ground truth" for individual samples (e.g., whether a urine sample actually contains a drug above a certain concentration) is typically established by definitive analytical methods, not human expert consensus.

4. Adjudication Method for the Test Set

• Not applicable in the typical sense for a qualitative diagnostic device where chemical analysis provides the "ground truth." The reference method itself (e.g., GC/MS, LC/MS) is considered the gold standard.

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 study was not done, and this is not an AI/Reader-based device. The Chemtrue® Multi-Panel DOA Dip Card Tests are rapid lateral flow immunoassays designed for direct visual interpretation. There is no AI component or human reader assistance mechanism to evaluate in an MRMC study. However, the document mentions "lay-user study information" in the predicate devices, which would assess how well a typical non-professional user can interpret the results, which is a form of human performance assessment.

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

• N/A. This is a physical, in vitro diagnostic test, not an algorithm, so the concept of "algorithm only" performance (standalone) does not apply. The device's performance is its direct ability to detect analytes in a given sample.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The implicit ground truth that would have been used for the predicate devices (and thus for these tests, by extension) is definitive analytical methods, specifically Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). The Indications for Use section explicitly states these are "the preferred confirmatory methods" to obtain a "confirmed assay result" after a preliminary result from the dip card.

8. The Sample Size for the Training Set

• Not explicitly stated for the individual analytes in this document, as it refers to previous 510(k)s. For this type of qualitative immunoassay, there isn't a "training set" in the machine learning sense. Instead, the "training" (or development and optimization) of the assay's chemical components (antibodies, conjugates) would involve numerous experiments with various concentrations of analytes and interferents to establish optimal performance around the cut-off.

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

• As mentioned above, there isn't a "training set" in the AI/ML context here. The development and validation of the chemical components and detection mechanisms for an immunoassay rely on precisely prepared samples with known concentrations of the target analytes, often verified by highly accurate analytical chemistry methods like GC/MS or LC/MS.

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The Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Card /Cup/Cassette Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine (BUP) and/or Tricyclic Antidepressants (TCA) drugs in human urine. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method 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 distinguish between prescription use or abuse of Buprenorphine and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for Buprenorphine and Tricvclic Antidepressants in urine.

The Chemtrue® Multi-Panel Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method 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 and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

The Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana. Opiates 2000. Methamphetamine. Phencyclidine. Benzodiazepines. Barbiturates. Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. 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 (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, Barbiturates, Buprenorphine, Oxycodone 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 the formats of dip card, cup, or cassette, as indicated by the test name.

Here's a breakdown of the acceptance criteria and the study information for the Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests, based on the provided text.

Acceptance Criteria and Device Performance

The acceptance criteria for this device are demonstrated through its performance in various studies, primarily focusing on reproducibility (precision) and method comparison (accuracy) against GC/MS (or LC/MS for some lay-user studies). The device aims to provide qualitative detection of drugs of abuse in human urine.

Acceptance Criteria (Implicit from Performance Studies):
The device is expected to:

• Consistently produce negative results for samples with no drug present or drug concentrations significantly below the cutoff (e.g., 50% of cutoff).
• Consistently produce positive results for samples with drug concentrations significantly above the cutoff (e.g., 125%, 150%, 200% of cutoff).
• Show predictable behavior around the cutoff, with a mix of positive and negative results when concentrations are at or near the cutoff (e.g., 75% of cutoff, cutoff).
• Demonstrate high agreement with confirmed analytical methods (GC/MS or LC/MS).
• Be free from interference from common substances/drugs.
• Maintain performance across a range of urine pH and specific gravity.
• Have a stable shelf-life.
• Be easily understood and used by lay-users (for OTC versions).

Table of Acceptance Criteria and Reported Device Performance (BUP & TCA only, as they are the new analytes):

• Negative (30 samples): 0 (+) / 30 (-)
• 50% Cutoff (30 samples): 0 (+) / 30 (-)
• 75% Cutoff (30 samples): 0 (+) / 30 (-)
• Cutoff (30 samples): 10 (+) / 20 (-)
• 125% Cutoff (30 samples): 30 (+) / 0 (-)
• 150% Cutoff (30 samples): 30 (+) / 0 (-)
  TCA Dip Card:
• Negative (30): 0 (+)/30 (-); 50% cutoff (30): 0 (+)/30 (-); 75% cutoff (30): 0 (+)/30 (-); Cutoff (30): 1 (+)/29 (-); 125% cutoff (30): 30 (+)/0 (-); 150% cutoff (30): 30 (+)/0 (-) |
  | Specificity | Cross-reactivity: No significant false positives from non-target compounds.
  Known Cross-reactants: Identified and quantified cross-reactivity for structurally similar compounds. | Low or no cross-reactivity with common substances/drugs at typical concentrations, and expected cross-reactivity with known related compounds. | Buprenorphine (BUP): Norbuprenorphine 10 ng/mL (100% cross-reactivity).
  Tricyclic Antidepressants (TCA): Nortriptyline 1000 ng/mL (100% cross-reactivity), Amitriptyline 1000 ng/mL (100%), Desipramine 300 ng/mL (333%), Imipramine 50 ng/mL (2000%), etc.
  Interference: Over 100 potential interferents tested and found not to cross-react at 100 µg/mL at ±25% of BUP and TCA cut-off. |
  | Method Comparison (Accuracy)| Agreement with GC/MS: High percentage agreement for both positive and negative results when compared to the gold standard GC/MS.
  Discordant Results: Limited number of discordant results, primarily near the cutoff concentration. | High sensitivity and specificity demonstrated by high agreement (e.g., >95-100%) with GC/MS for samples well above or below the cutoff. | BUP Dip Card:
• Agreement for Positives: 100% (based on 33 samples: 2 near-cutoff neg, 6 near-cutoff pos, 25 GC/MS pos)
• Agreement for Negatives: 96.3% (based on 52 samples: 40 no drug, 7 GC/MS neg, 5 near-cutoff neg)
  TCA Dip Card:
• Agreement for Positives: 100% (based on 34 samples: 0 near-cutoff neg, 8 near-cutoff pos, 26 GC/MS pos)
• Agreement for Negatives: 100% (based on 55 samples: 40 no drug, 6 GC/MS neg, 9 near-cutoff neg)
  Discordant: 2 discordant results for Buprenorphine (9.5 and 9.8 ng/mL GC/MS value, but device read positive). |
  | Effect of Urine pH & Specific Gravity | Consistent performance across physiological ranges. | Test performance unaffected by urine pH 3.0 to 8.5 and specific gravity 1.002 to 1.030. |
  | Lay-user Studies (OTC) | Agreement with LC/MS: High percentage agreement with LC/MS across various drug concentrations.
  Ease of Use: High percentage of users find instructions easy to follow. | High accuracy when used by lay-users; clear and understandable instructions. | BUP Lay-user (Dip Card): 100% agreement across all tested concentrations (no drug, 50%, 75%, 125%, 150%, 200% of cutoff).
  TCA Lay-user (Dip Card): 100% agreement except for 75% of cutoff (1 positive/29 negative, 96.7% agreement).
  Ease of Use: 99% of lay-users found the instructions easy to follow. Flesch-Kincaid reading grade level

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The Chemtrue® hCG Pregnancy Urine Midstream Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Midstream. The test is designed to aid early detection of pregnancy by home users. The device is intended for Over-The-Counter (OTC) Use.

The device employs lateral flow immunoassay technology for detection of human chorionic gonadotropin (hCG) in urine. Monoclonal goat anti-hCG antibodies are pre-striped in the nitrocellulose membrane on the test region (T line) and goat antibodies on the control region (C line). During testing, the urine/serum specimen reacts with the conjugate pad (It contains colloidal gold particles conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG) located just beneath the sample pad and above the membrane of the test strip. The specimen migrates upward on the membrane by capillary action to react with the antibodies on the membrane. If the hCG concentration in the specimen is at or above the designated detection limit, a red colored line at the test region will be present indicating a positive result, while its absence indicates a negative result. The control line (C line) serves as an internal quality control. The control line should always appear, regardless of the hCG concentration of the test specimen, and the C line is an indicator that sufficient sample volume has been added to the test device and the sample has correctly migrated up the test strip.

The device is designed in Midstream format. Each device consists of one (1) individual test strip and each test strip in the device consists of:

• 1. A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG.
• 2. A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line). Presence of this line indicates that the test is performed correctly. A test result is read at three (3) minutes and the cut-off of the device is 20 mIU/mL hCG.

The Midstream Test kit consists of one test device in a foil pouch and a package insert.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

• 10 mIU/mL: 0/15 positive (across 3 lots)
• 15 mIU/mL: 3/15 positive (some variability below cutoff, but mostly negative)
• 20 mIU/mL: 15/15 positive (across 3 lots)
• 40 mIU/mL: 15/15 positive (across 3 lots)
• 80 mIU/mL: 15/15 positive (across 3 lots)
  Conclusion: Confirmed cutoff of 20 mIU/mL. |
  | Reproducibility/Precision| Consistent functional performance across different sites and operators at various hCG concentrations. At 20 mIU/mL and above, 100% positive results. At 0 mIU/mL and 10 mIU/mL, 100% negative results. | * 0 mIU/mL: 0/27 positive (across 3 sites)
• 10 mIU/mL: 0/27 positive (across 3 sites)
• 15 mIU/mL: 3/27 positive (showing some variability below cutoff)
• 20 mIU/mL: 27/27 positive (across 3 sites)
• 25 mIU/mL: 27/27 positive (across 3 sites)
• 30 mIU/mL: 27/27 positive (across 3 sites)
• 35 mIU/mL: 27/27 positive (across 3 sites)
  Conclusion: Consistent functional performance between sites. |
  | Analytical Specificity | No interference from structurally-related hormones (hLH, hFSH, hTSH), common exogenous compounds, β-core hCG fragment, varying pH, and specific gravity. | * hLH, hFSH, hTSH: No interference at specified concentrations (1000 IU/L FSH, 500 IU/L LH, 1000 IU/L TSH) for both negative (5mIU/mL hCG) and positive (50mIU/mL hCG) samples.
• Exogenous Compounds: No interference observed at specified concentrations for 17 tested compounds (e.g., Acetylsalicylate Acid, Albumin, Ascorbic Acid, Glucose, Hemoglobin) for both negative (0mIU/mL hCG) and positive (20mIU/mL hCG) samples.
• β-core hCG fragment: No interference observed up to 1,000,000 pmol/mL for samples containing 5 mIU/mL and 50 mIU/mL hCG.
• pH: No interference observed over pH range 2.0 to 9.0 for 0 and 20 mIU/mL hCG.
• Specific Gravity: No interference observed over SG range 1.003 to 1.030 for 0 and 20 mIU/mL hCG. |
  | High Dose/Hook Effect | No hook effect observed at high hCG concentrations. | No hook effect observed up to 500 IU/mL hCG. |
  | Method Comparison | 100% agreement with the predicate device when tested by healthcare professionals. | 100% agreement (150 positive, 150 negative) with OSOM® Card II hCG-Urine Test. |
  | OTC Lay-user Performance | 100% agreement between lay-users' results and HCPs' results. Lay-users should be able to correctly interpret results and find the test easy to use based on labeling. | * Agreement: 100% agreement between lay-user (midstream) and HCP (dip method) results (55 positive, 45 negative).
• Cutoff confirmation by lay-users: 0/33 positive at 10 mIU/mL, 2/34 positive at 15 mIU/mL, 33/33 positive at 25 mIU/mL (similar to HCP results).
• Usability: Questionnaire results indicated consumers found the test easy to use and understood labeling. Flesch-Kincaid Grade Level 7 for labeling. |
  | Stability | Device stable for a specified shelf-life. | Devices stable for 24 months when stored at 25±2ºC in a sealed foil pouch (supported by real-time and accelerated stability at 40°C and 60°C). |

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Sensitivity: 15 replicates per hCG concentration level, across 3 lots (total 90 tests at key cutoff levels). Data provenance is not explicitly stated as retrospective vs. prospective, but based on the description of spiked samples and blind coding, it appears to be a prospective experimental study conducted by the manufacturer.
   • Reproducibility (Precision): Not explicitly stated as a single "test set" size, but the study involved 9 operators in 3 POL sites, testing 8 hCG concentrations, across 3 lots, over 5 nonconsecutive days. This equates to 9 operators * 3 lots * 5 days * 8 concentrations = 1080 data points, though the table shows 9 tests per site * 3 sites = 27 tests per concentration level total. The data provenance is a prospective multi-site experimental study.
   • Analytical Specificity:
     • Hormones: Test performed with spiked hCG negative (5mIU/mL) and positive (50 mIU/mL) samples across 3 lots. Sample size for each hormone level is not explicitly stated but implies multiple replicates.
     • Exogenous Compounds: Samples containing 0 and 20 mIU/mL hCG spiked with interferents, tested using 3 different lots. Sample size for each compound is not explicitly stated but implies multiple replicates (e.g., "samples were tested").
     • β-core hCG fragment: 5 replicates from 3 lots (total 15 tests per hCG and fragment concentration combination).
     • pH & Specific Gravity: Duplicate tests at each level for each test format.
   • High Dose/Hook Effect: 5 replicates per hCG concentration level across 3 lots (total 75 tests).
   • Method Comparison Study: 300 urine samples (100 women from each of 3 hospitals). Approximately half were suspected pregnant. Data provenance is prospective from "women presenting at three (3) hospitals to test for pregnancy." Likely domestic U.S. data given FDA 510(k).
   • OTC Lay-user Study: 100 women for the natural urine samples, and 100 aliquots of spiked samples (for 10, 15, 25 mIU/mL hCG each). Data provenance is prospective, conducted at three (3) clinical sites in women with varied education backgrounds and ages 22-39. Likely domestic U.S. data.

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

   • Sensitivity, Reproducibility, Analytical Specificity, High Dose/Hook Effect: Ground truth was established by known concentrations of hCG or interferents added to urine pools, traceable to WHO International Standards. No human experts established ground truth for these analytical performance studies.
   • Method Comparison Study: The predicate device, OSOM® Card II hCG-Urine Test (K990578), served as the reference standard (ground truth) for agreement. The results with the new device were compared to the results of the predicate device when used by healthcare professionals. The qualifications of these professionals are not detailed beyond "healthcare professionals."
   • OTC Lay-user Study: The ground truth for the natural urine samples was established by the results obtained by healthcare professionals (HCPs) using the dip method with the Chemtrue® hCG device. For the spiked samples, the ground truth was the known spiked concentrations of hCG. The qualifications of these HCPs are not detailed beyond "healthcare professionals."

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

   The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus reading) for interpreting results in any of the studies.

   • For the sensitivity and reproducibility studies, results were read by operators (e.g., "five (5) replicates were tested at each hCG control level by three (3) operators," "interpreted by the same operator each day"). Consistency across operators/lots/sites was checked.
   • For method comparison, healthcare professionals read the proposed and predicate devices.
   • For the lay-user study, lay-users interpreted their own test and HCPs interpreted their own test.
     The primary assessment method appears to be direct observation of the visually-read line intensity by the designated individual(s).

4. 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 involving AI assistance was not done. The device is a visually-read, self-contained rapid diagnostic test, not an AI-powered diagnostic imaging or interpretation system. The "readers" are either healthcare professionals or lay-users interpreting a physical test strip, not an AI algorithm.

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

   No, a standalone algorithm-only performance study was not done. This device is a manual, visually-read test kit; it does not involve a digital algorithm.

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

   • Analytical Studies (Sensitivity, Reproducibility, Specificity, Hook Effect): The ground truth was known, traceable concentrations of hCG or interferents in urine matrix, calibrated against WHO International Standards. This is a form of analytical reference standard.
   • Method Comparison Study: The ground truth was the results obtained from the predicate device (OSOM® Card II hCG-Urine Test), interpreted by healthcare professionals. This acts as a previously accepted reference method.
   • OTC Lay-user Study: For patient samples, the ground truth was the results obtained from healthcare professionals using the new device. For spiked samples, it was the known concentrations of hCG in the spiked aliquots. This combines expert interpretation and analytical reference standard.

7. The sample size for the training set:

   The document does not describe training data or a training set because this device is a qualitative lateral flow immunoassay, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI.

8. How the ground truth for the training set was established:

   As there is no training set for an AI algorithm, this question is not applicable.

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The Chemtrue® hCG urine or Combo test is a rapid lateral flow immunoassay for the visual qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum as an aid in the early determination of pregnancy. The Dipstick/Cassette and Combo Tests are for prescription use only, including at physician's offices or other Point-Of-Care sites (POC).

The Chemtrue® hCG urine test is designed in Dipstick and Cassette formats. The hCG Combo (Serum/Urine) test is available in Cassette format only. Each test device consists of one (1) individual test strip and each test strip in the device consists of:

1. A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG.
2. A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line serves as an internal quality control of the system and appears as a colored band during the test regardless of the hCG level in the test sample.
   All the configurations have the same membrane format, reagents and gold conjugate pad, as well as the same flow characteristics, except the test line in the nitrocellulose membrane for hCG Combo test is striped with polyclonal goat anti-hCG antibodies.
   Devices are packaged one device per foil pouch and 25 devices in each kit.

Here's a breakdown of the acceptance criteria and study information for the Chemtrue® Human Chorionic Gonadotropin (hCG) Pregnancy Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a bulleted list prior to presenting results, but rather demonstrates performance against the intended claims (e.g., cutoff levels, agreement with predicate). Based on the performance data, the implicit acceptance criteria are that the device demonstrates comparable sensitivity and specificity to the predicate devices, and consistent performance across lots, sites, and operators.

Chemtrue® hCG Pregnancy Urine Dipstick Test & Cassette Test (Cutoff: 20 mIU/mL)

Chemtrue® hCG Combo (Serum/Urine) Cassette Test (Cutoff: 25 mIU/mL)

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

• Sensitivity (Cutoff Characteristics) Study:

  • Sample Size: For each device format (Dipstick, Cassette, Combo Urine, Combo Serum), 3 lots were tested. For each lot, 6 hCG concentration levels (0, 10, 15, 20, 40, 80 mIU/mL for urine tests; 0, 10, 20, 25, 50, 100 mIU/mL for combo tests) were used with 5 replicates each.
    • Total for Urine tests: 3 lots * 6 concentrations * 5 replicates = 90 tests per urine format (Dipstick, Cassette)
    • Total for Combo tests: 3 lots * 6 concentrations * 5 replicates = 90 tests per Combo format (Urine, Serum)
  • Data Provenance: Spiked hCG urine/serum pools from non-pregnant donors. The origin of the donors/samples is not specified (e.g., country), but they are described as "human urine pool from non-pregnant donors" and "non-pregnant human serum and urine pools." This is a prospective spiking study.

• Reproducibility (Precision) Study:

  • Sample Size:
    • For each device format (Dipstick, Cassette, Combo Urine, Combo Serum), 3 lots were tested.
    • 7 hCG concentration levels for urine (0, 10, 15, 20, 25, 30, 35 mIU/mL) and 6 for serum (0, 15, 20, 25, 30, 35 mIU/mL).
    • Tested over 3 non-consecutive days with 3 operators per site across 3 sites. Each operator tested each control level (implied that 1 replicate for each level was run by each operator per day).
    • Calculation per device format and concentration level: 3 lots * 3 sites * 3 operators = 27 data points.
  • Data Provenance: Spiked hCG urine/serum controls, calibrated against WHO 5th IS, confirmed with Abbott i2000 instrument. The study was conducted at "three (3) POL sites." The geographical location of these POL sites is not explicitly stated. This is a prospective spiking study.

• Method Comparison Study:

  • Sample Size:
    • Urine: 300 clinical urine samples (150 hCG negative, 150 hCG positive).
    • Serum: 100 clinical serum samples (50 hCG negative, 50 hCG positive).
  • Data Provenance: Clinical samples from women who were suspected to be pregnant or non-pregnant women of childbearing age (including peri-menopausal). The study was conducted at "three (3) POL sites... in Shanghai China." The data is retrospective clinical samples (but prospective testing with the device).

• Analytical Specificity (Cross-reactivity) Study:

  • Sample Size: For each device format, 3 lots were tested. hLH, hFSH, hTSH, and other interfering substances were spiked into hCG negative and 50 mIU/mL controls (number of replicates not explicitly stated for all, but typically done in replicates).
  • hCGBcf interference: For each device format (Dipstick, Cassette, Combo Urine, Combo Serum), 3 lots were tested. 5 and 50 mIU/mL hCG controls were spiked with 4 hCGBcf concentrations. 10 replicates for each condition were tested (e.g., 3 lots * 2 hCG concentrations * 4 hCGBcf concentrations * 10 replicates = 240 tests for Dipstick, and similarly for other formats).
  • Data Provenance: Spiked samples.

• High Dose (Hook Effect) Study:

  • Sample Size: For each device format (Urine Tests: Dipstick, Cassette; Combo Tests: Urine, Serum), 3 lots were used. 5 hCG concentrations (50, 100, 200, 300, 500 IU/mL) were tested with 5 replicates per lot.
    • Total for Urine tests: 3 lots * 5 concentrations * 5 replicates = 75 tests per urine format.
    • Total for Combo tests: 3 lots * 5 concentrations * 5 replicates = 75 tests per combo format.
  • Data Provenance: Spiked non-pregnant urine and serum pools.

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

The ground truth for the test sets (except method comparison and analytical specificity, discussed below) was established by spiking known concentrations of hCG into negative samples, and these concentrations were "quantitatively confirmed by Abbott i2000 instrument." This means there were no human experts establishing ground truth for the spiked studies.

For the Method Comparison Study:

• The "hCG positive serum samples were quantitatively confirmed by Abbott i2000 instrument." This establishes a quantitative ground truth for positive samples.
• The "150 hCG negative urine samples (collected from women of childbearing age, including peri-menopausal)" and "50 hCG negative serum samples" implicitly had their negative status confirmed, likely through prior testing or knowledge that they were from non-pregnant individuals.
• For the comparison itself, the predicate devices (Genzyme Diagnostics OSOM® Card hCG Urine Test (K990578) and Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test (K964461)) served as the reference standard against which the new devices were compared. The predicate devices themselves would have been cleared based on their own performance against a ground truth. No specific "experts" are mentioned as establishing ground truth for this comparative study beyond the established performance of the predicate and quantitative instrumentation.

For Analytical Specificity (Cross-reactivity): The "ground truth" was the known presence of specific interfering substances and the known absence or presence of hCG at specific concentrations.

4. Adjudication Method for the Test Set

• Sensitivity, Reproducibility, High Dose, Analytical Specificity, and pH/SG studies: The results were interpreted at 5 minutes by the "same operator" who performed the test in the reproducibility study. In the sensitivity study, "three (3) operators" tested the samples. These studies used objective criteria (presence/absence of a line) and known hCG concentrations, so an explicit adjudication method beyond visual interpretation by the operator (or in some cases, multiple operators) is not described or typically required for this type of qualitative assay performance testing using spiked samples.
• Method Comparison Study: "Each specimen was evenly split into three aliquots. Each site tested 100 samples with a unique set of blind codes for each device formation." The test device's result was then compared to the predicate device's result. Discrepancies are noted (e.g., "One discrepant result in this table was from a single sample with a hCG concentration near the cut-off"). No explicit multi-reader adjudication method (like 2+1) is mentioned, as the comparison is against an established predicate device.

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

No, a formal MRMC comparative effectiveness study was not explicitly done in the sense of comparing human readers with and without AI assistance. This document describes a traditional in-vitro diagnostic (IVD) device (a lateral-flow immunoassay) which is interpreted visually by a human. The studies performed are standard IVD performance characteristic studies.

The "Method Comparison Study" involved multiple operators (9 operators across 3 sites in Shanghai, China), but this was comparing the device's performance to a predicate device, not comparing human reader effectiveness with and without AI. It demonstrated that human readers could use the new device to achieve results comparable to predicate devices. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not applicable here.

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

Yes, in essence, the fundamental performance characteristics (Sensitivity/Cutoff, Analytical Specificity, High Dose, pH/SG, Stability) of the device itself were tested in a standalone manner by evaluating its ability to correctly identify various concentrations of hCG or detect interfering substances, independent of human variability in clinical settings. These are tests of the device's inherent analytical performance.

However, since this is a visually-read qualitative immunoassay, the final "output" is inherently derived from human observation. The "Reproducibility (Precision) Study" assessed the consistency of this human observation across multiple users and sites, ensuring that the human-in-the-loop interpretation provided reliable results.

7. The Type of Ground Truth Used

• For Sensitivity/Cutoff, Reproducibility, Analytical Specificity, High Dose, pH/SG studies: The ground truth was known concentrations of hCG or other substances that were quantitatively confirmed by a reference instrument (Abbott i2000) or laboratory standards (WHO 5th IS 07/364). This is considered an analytical ground truth based on spiked samples.
• For Method Comparison Study: The ground truth for clinical samples was established by comparison against legally marketed predicate devices (Genzyme Diagnostics OSOM® Card hCG Urine Test and Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test). For serum samples, the hCG positive status was also quantitatively confirmed by an Abbott i2000 instrument. This is a comparative ground truth against an existing, cleared device, supported by quantitative confirmation for positives.

8. The Sample Size for the Training Set

The document describes the submission as a premarket notification (510(k)) for a new device. It does not explicitly mention a "training set" in the context of machine learning algorithms. This device is a lateral flow immunoassay, which does not typically involve training a computational algorithm. The studies described are performance validation studies for the finished device.

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

As there is no mention of a "training set" in the context of a machine learning algorithm, this question is not applicable. The device's fundamental design is based on immunological principles, not learned from a dataset.

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The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designated cutoff concentrations of each drug and the calibrators used for these drugs are as follows:

Analyte Abbreviation Calibrator Cutoff Concentration
Benzodiazepines BZO Oxazepam 300 ng/mL
Barbiturates BAR Secobarbital/Pentobarbital 300 ng/mL
Ecstasy MDMA/XTC d,l-Methylenedioxymethamphetamine 500 ng/mL
Methadone MTD Methadone 300 ng/mL
Opiates OPI/MOR Morphine 2000 ng/mL
Oxycodone OXY Oxycodone 100 ng/mL

The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for health care professionals, in vitro diagnostic and Over-The-Counter (OTC) use.

The BAR.BZO and OXY assay will yield preliminary positive results when BAR, BZO, and OXY is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepine and Oxycodone in urine. The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Div Card Tests shows the drug was or was not present at the cutoff level. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for tri-cyclic antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Drugs of Abuse (DOA) Screen Panels are one-step lateral flow immunoassays in which chemically labeled drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may be present in urine. The test device consists of up to six test strips placed in separate panels of a plastic holder. On each test strip, a drug-protein conjugate is striped on the test band of the membrane - known as the test region (T) and the drug antibody-colloidal gold conjugate pads are placed at one end of the membrane (opposite in morphine). In the absence of drugs in the urine, the solution of the colored antibody-colloidal gold conjugates move along with the sample solution upward chromatographically by capillary action across the membrane to the immobilized drug-protein conjugate zones on the test band region. The colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible precipitant in the test band occurs when the test urine is negative for the drug. If any drug is present in the urine, the drug/metabolite antigen competes with the drugprotein conjugates on the test band region for the limited antibody on the colored drug antibodycolloidal gold conjugate pad. When a sufficient amount of drug is present in the urine, the drug will saturate the limited antibody binding sites and the colored antibody-colloidal gold conjugate cannot bind to the drug-protein conjugate at the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result.

A control band with a different antigen/antibody reaction is added to the membrane strip at the control region (C) to indicate that the test has performed properly. This control line is manufactured as a built-in internal control of the test device and should always appear regardless of the presence of drug or metabolite. If the control line does not appear the test cassette should be discarded. The presence of this colored band in the control region also serves 1) as verification that adequate specimen volume is added (flooding, if too much urine is added, or no flow, due to insufficient urine volume), 2) the test device is properly functioning, and 3) as reagent control.

The acceptance criteria for the Chemtrue® Single/Multi-Panel Drug Screen Dip Card / Cassette Tests are implicitly defined by the reported agreement with GC/MS values in the OTC accuracy study, with a target of "greater than 97.8% accuracy" for lay users and "≥97.8% agreement" with GC/MS. The study demonstrates that lay users can perform and interpret the results correctly with the specified accuracy, and that the device's performance is substantially equivalent to the GC/MS reference method.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The study involved a total of 200 OTC lay-users. 100 lay-users tested the Dip Card format, and 100 lay-users tested the Cassette format. Within each format, the results table shows varying numbers of samples tested for each drug, typically with 30 samples in each category (e.g., "no drug present," "GC/MS Negative," "Near cutoff negative," etc.), suggesting at least ~90 positive and ~90 negative samples per drug per format for GC/MS comparison, plus samples in the near-cutoff ranges. The exact total number of unique urine samples is not explicitly stated but implies a substantial number.
• Data Provenance: The data was generated from "three (3) independent sites" through an "OTC accuracy study." The nationality of the participants is not explicitly stated but, given the FDA submission, it can be inferred to be from the United States. The study appears to be prospective as it involved selecting and having lay-users perform tests.

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

• The ground truth for the test set was established using Gas Chromatography / Mass Spectrometry (GC/MS), which is referred to as "the preferred confirmatory method."
• There were no human experts explicitly described as establishing the ground truth for the test results themselves. The "experts" in this context would be the technicians or laboratory personnel operating and interpreting the GC/MS results, whose qualifications are not specified but are implicitly assumed to be trained professionals for performing such confirmatory chemical analyses.

4. Adjudication Method for the Test Set

• No explicit adjudication method (e.g., 2+1, 3+1) for the interpretation of the test device was used in the lay-user study. The lay-users themselves interpreted the results, and their interpretation was compared against the GC/MS ground truth.
• Discordant results were identified and reported with their GC/MS values, but no process of expert re-adjudication of the test device result itself is described. The agreement percentage directly reflects the lay-user interpretation versus GC/MS.

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

• No MRMC comparative effectiveness study was done to compare human readers with AI assistance versus without AI assistance. This device is a rapid diagnostic test with a visual interpretation by the user (lay-user in this case), not an AI-powered diagnostic system that assists human readers.

6. Standalone Performance Study

• Yes, a standalone study was done, specifically the "OTC accuracy study." This study evaluated the performance of the algorithm (i.e., the rapid immunoassay device) when interpreted by a human (lay-users) without any additional human-in-the-loop assistance beyond the instructions provided. The device's performance was compared directly to objective GC/MS results. The results presented in Tables 1 and 2 show the direct agreement rates of the device's output (interpreted by lay-users) with the GC/MS reference.

7. Type of Ground Truth Used

• The type of ground truth used was chemical confirmatory method: Gas Chromatography / Mass Spectrometry (GC/MS). For tri-cyclic antidepressants, HPLC is mentioned as the preferred method, but the drugs in this submission primarily relied on GC/MS.

8. Sample Size for the Training Set

• The document does not explicitly state a sample size for a training set. This device is a rapid immunoassay, which does not typically involve a "training" phase in the same way machine learning or AI models do. The device's formulation and design are developed, and then its performance is validated through studies like the one described. The "Analytical sensitivity (Cut-off characteristics), precision (reproducibility), Accuracy (Method comparison study with clinical samples), specificity and stability study data were established in K111322," which was the predicate device. These earlier studies would have involved samples for the initial characterization and validation but are not detailed here as a "training set."

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

• As there's no explicitly defined "training set" for an AI or machine learning algorithm, this question isn't directly applicable in the context of this immunoassay device. The ground truth for the development and validation of the immunoassay (e.g., for setting cut-off concentrations, verifying specificity) would have been established through controlled studies using spiked samples and clinical samples, with reference methods such as GC/MS. The document refers to "Performance Data" and states that "Analytical sensitivity (Cut-off characteristics), precision (reproducibility), Accuracy (Method comparison study with clinical samples), specificity and stability study data were established in K111322" (the predicate device's submission), implying that these data, likely using GC/MS or similar reference methods, formed the basis for establishing the device's characteristics.

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The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and the calibrators used for these drugs are as follows:

Analyte Abbreviation Calibrator Cutoff Concentration
Amphetamine AMP d-Amphetamine 1000 ng/mL
Cocaine COC Benzoylecgonine 300 ng/mL
Marijuana THC 11-nor-Δ9-THC9-COOH 50 ng/mL
Methamphetamine MET d-Methamphetamine 1000 ng/mL
Opiates OPI/MOR Morphine 300 ng/mL
Phencyclidine PCP Phencyclidine 25 ng/mL

The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for health care professional, in vitro diagnostic and Over-the-Counter (OTC) use. These assays provide only a preliminary result. A more specific alternative chemical method 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 Drugs of Abuse (DOA) Screen Panels are one-step lateral flow immunoassays in which chemically labeled drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may be present in urine. The test device consists of up to six test strips placed into separate panels of a plastic holder. On each test strip, a drug-protein conjugate is striped on the test band of the membrane - known as the test region (T) and the drug antibody-colloidal gold conjugate pads are placed at one end of the membrane (opposite in morphine). In the absence of drugs in the urine, the solution of the colored antibody-colloidal gold conjugates move along with the sample solution upward chromatographically by capillary action across the immobilized drug-protein conjugate zones on the test band region. The colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible precipitant in the test band occurs when the test urine is negative for the drug. If any drug is present in the urine, the drug/metabolite antigen competes with drug-protein conjugates on the test band region for the limited antibody on the colored drug antibody-collooidal gold conjugate pad. When a sufficient amount of drug is present in the urine, the drug will saturate the limited antibody binding sites and the colored antibody -colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result.

A control band with a different antibody reaction is added to the membrane strip at the control region (C) to indicate that the test has performed properly. This control line is manufactured as a builtin internal control of the test device and should always appear regardless of the presence of drug or metabolite. If the control line does not appear the test cassette should be discarded. The presence of this colored band in the control region also serves 1) as verification that adequate specimen volume is added (flooding, if too much urine is added, or no flow, due to insufficient urine volume), 2) the test device IS properly functioning, and 3) as reagent control.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria for this device are its accuracy of detection for various drugs of abuse when compared to a confirmatory method (GC/MS). The study aimed to demonstrate that lay-users could perform the testing and interpret the results correctly with a high level of agreement.

Table 1: Acceptance Criteria and Reported Device Performance (Summary from provided text)

Note: The document explicitly states "Correlation studies produced a 98.9% total correlation when compared to the GC/MS methodology" as the overarching performance metric, suggesting this was the primary acceptance criterion. The individual agreement percentages for each drug further support the overall claim.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: The study evaluated 200 OTC (Over-the-Counter) lay-users. The tables provided show results for various drug concentrations, including "no drug present", "GC/MS Negative (-50% to -25% cutoff)", "Near cutoff negative (-25% cutoff to cutoff)", "Near cutoff positive (cutoff to +25% cutoff)", "GC/MS Positive (+25% to +50% cutoff)", and "GC/MS Positive (+50% to 200% cutoff)". For each of these categories and for each drug, there were typically 30 samples, indicating a total of 180 samples per drug, and thus 1080 samples across all 6 drugs for each device type (Dip Card and Cassette). The document states "blind-labeled spiked urine correlation study," implying the urine samples were prepared and then tested.
   • Data Provenance: The study used "spiked urine" samples, meaning the drug concentrations were artificially introduced into urine. The samples were tested by lay-users from "three (3) sites". It's not explicitly stated if these sites were in a specific country, but given the company's address (San Diego, CA, USA) and the FDA submission, it's highly probable the study was conducted in the USA. The study design is prospective in the sense that new tests were run according to a predefined protocol.

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

   • Number of experts: Not applicable in the traditional sense of human expert consensus. The ground truth was established by a laboratory method.
   • Qualifications: The gold standard for establishing ground truth was Gas Chromatography / Mass Spectrometry (GC/MS) methodology. This is a highly accurate analytical chemistry technique performed by trained laboratory personnel.

3. Adjudication method for the test set:

   • Adjudication: Not applicable. The ground truth was determined by GC/MS, so there was no need for human expert adjudication to resolve discrepancies in ground truth. The study compared the device's reading to the GC/MS result directly.

4. 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:

   • MRMC Study: No, an MRMC comparative effectiveness study was not performed in the context of human readers improving with or without AI assistance. This device is a rapid, visually-read immunoassay, not an AI-powered diagnostic tool requiring interpretation by experts in an MRMC setting. The study assessed the ability of "200 OTC lay-users" to correctly interpret the visual results of the device.

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

   • Standalone Performance: No, a standalone algorithm-only performance was not done. The device is a "visually-read" immunoassay where human users (specifically "lay-users" for OTC use) interpret the presence or absence of colored lines. The reported performance includes the human interpretation component.

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

   • Type of Ground Truth: The ground truth was established using an analytical reference method: Gas Chromatography / Mass Spectrometry (GC/MS). This is a highly accurate chemical method for identifying and quantifying substances in a sample. The document also mentions Liquid Chromatography / Mass Spectrometry (LC/MS) as an alternative confirmatory method.

7. The sample size for the training set:

   • Training Set Sample Size: The document does not explicitly state a training set size. For this type of immunoassay device, there isn't typically a "training set" in the machine learning sense. The device's performance characteristics (e.g., analytical sensitivity, precision, specificity, stability) were established and likely optimized during product development, but this process isn't described as using a distinct "training set" in the filing. The "K102203" submission is referenced for "Other performance data" such as analytical sensitivity and precision, which would have been part of the internal development and validation, not a separate training set as understood in AI/ML.

8. How the ground truth for the training set was established:

   • Training Set Ground Truth: As there's no explicitly defined "training set" in the context of this immunoassay's submission, the method for establishing its ground truth is not detailed via this document. However, the foundational analytical sensitivity and specificity of immunoassays are typically established by running known concentrations of analytes and interferents and confirming these with reference methods like GC/MS or LC/MS during the assay's development and internal validation.

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The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and the calibrators used for these drugs are as follows:

The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for in vitro diagnostic and prescription use ONLY. They are not intended for point-of-care settings or over the counter use. These assays provide only a preliminary result. A more specific alternative chemical method 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 Drugs of Abuse (DOA) Screen Panels are one-step lateral flow immunoassays in which chemically modified drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may be present in urine. The test device consists of up to six test strips placed into separate panels of a plastic holder. On each test strip, a drug-protein conjugate is striped on the test band of the membrane - known as the test region (T) and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane.

The Chemtrue® Single/Multi-Panel Drug Screen Tests are qualitative immunoassays designed to detect up to six drugs of abuse in human urine. The acceptance criteria for this device are defined by its performance in detecting specific drugs at or above their established cutoff concentrations, as compared to a reference method (GC/MS).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Overall Agreement" percentages with the GC/MS reference method. While explicit pass/fail thresholds are not stated here, the reported high agreement percentages indicate that the device meets an acceptable level of performance for clinical utility.

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

The studies used clinical specimens for the test set.

• BZO: 203 samples (Dip Card and Cassette)
• BAR: 190 samples (Dip Card and Cassette)
• MDMA: 101 samples (Dip Card and Cassette)
• MTD: 104 samples (Dip Card and Cassette)
• OPI(MOR)2000: 106 samples (Dip Card and Cassette)
• OXY: 106 samples (Dip Card and Cassette)

The data provenance is from clinical specimens, implying a retrospective study design where samples were collected and then tested. The document does not specify the country of origin.

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

This information is not provided in the document. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method, not human expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was established by an objective chemical method (GC/MS), not human adjudication.

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

This is not applicable. The device is an immunoassay for drug screening, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are outside the scope of this device.

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

Yes, the performance study (method comparison) represents a standalone evaluation of the device. The Chemtrue® cassettes and dip cards were compared directly against the GC/MS reference method, acting as an "algorithm only" in the sense that its output (positive/negative) was assessed independently of human interpretation influence beyond reading the test lines.

7. The Type of Ground Truth Used

The ground truth used was analytical/objective data from Gas Chromatography/Mass Spectrometry (GC/MS). The document states: "Samples with drug concentration above the cut-off level were considered presumptive positive and concentration below the cut-off were considered negative." and "The product performance characteristics of were evaluated with the GC/MS confirmed values in a blind-labeled clinical specimen correlation study."

8. The Sample Size for the Training Set

The document does not provide information regarding a distinct training set. The device is a lateral flow immunoassay, a chemical sensing technology, and not typically developed using machine learning models that require explicit training sets in this context.

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

As no training set is described for this type of device, this information is not applicable. The device's performance characteristics (such as antibody specificity and cutoff concentrations) are established during the assay development and manufacturing process, not through a 'training set' in the machine learning sense.

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