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510(k) Data Aggregation

    K Number
    K142396
    Device Name
    Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
    Manufacturer
    Chemtron Biotech, Inc.
    Date Cleared
    2014-10-09

    (43 days)

    Product Code
    DJG,LFG
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    k102203,k111322,k121339,k123080,k061718
    Predicate For
    K152025,K153465,K161044,K170049,K180255,K181790,K181968,K182654
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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):

    Study TypePerformance MetricAcceptance Criteria (Implicit)Reported Device Performance (Example for BUP Dip Card)
    Reproducibility (Precision)Negative Samples: 100% negative results significantly below cutoff. Positive Samples: 100% positive results significantly above cutoff. Near Cutoff: Demonstrates consistent performance, with an expected increase in positive results as concentration approaches and exceeds cutoff.High consistency in results across different operators, lots, and days, especially for samples significantly below and above the cutoff.BUP Dip Card: - 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 (-)
    SpecificityCross-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 GravityConsistent 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 < 7.

    Study Details

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

      • Reproducibility (Precision) Studies:
        • Test Set Size: For each analyte (BUP and TCA) and each format (Dip Card, Cup, Cassette), there were 6 concentration levels (Negative, 50% cutoff, 75% cutoff, Cutoff, 125% cutoff, 150% cutoff). Each level was tested in 10 replicates across 3 lots and 3 operators.
        • Total Samples per Analyte-Format Combination: 6 concentrations * 10 replicates = 60 samples. Since 3 lots were used, this implies 180 tests per concentration level total (60 per lot). The tables show n=30 per concentration level, which suggests 30 replicates per concentration (10 replicates x 3 lots total, assigned to 3 operators).
        • Data Provenance: The samples were "GC/MS confirmed drug spiked samples." This implies they were prepared in a lab, not directly from patients, but confirmed by a reference method. The country of origin of the data is not specified, but the submission is to the US FDA.
      • Method Comparison Studies (Accuracy):
        • Test Set Size: A total of 174 clinical specimens were used for BUP/TCA combined across all formats. Given three formats (Dip Card, Cup, Cassette) and two analytes (BUP, TCA), this number of specimens would have been divided among these. The individual tables for each format show ~50-60 samples per analyte per format for calculation of agreement percentages across different concentration categories (e.g., for BUP Dip Card, agreement for negative was based on 52 samples, and for positive on 33 samples).
        • Data Provenance: "blind-labeled clinical specimen correlation study". This suggests retrospective clinical samples, though the country of origin is not specified.
      • Lay-user Studies (OTC):
        • Test Set Size: A total of 300 people participated. Each lay-user was given "up to two blind labeled samples and test device(s)".
        • Total Samples: The tables show 30 replicates for each of 6 concentration levels for both BUP and TCA and for each of the three device formats. This implies 6 levels * 30 replicates = 180 total tests for BUP, and 180 for TCA, for each device format in the lay-user study.
        • Data Provenance: "LC/MS confirmed urine samples...by spiking drugs into drug-free urine pool." This means the samples were prepared in a lab and confirmed by LC/MS, not directly from patients. The study was conducted at "three (3) intended user sites," implying these were likely in a controlled setting for observational use. Country of origin not specified.

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

      • For the Reproducibility (Precision) Studies and Method Comparison Studies, the ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and generally accepted reference method for drug confirmation. The document does not specify human experts for establishing GC/MS results or their qualifications.
      • For the Lay-user Studies, the ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry). Similar to GC/MS, this is a highly accurate analytical method, and human expert qualifications for interpreting these results are not specified.

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

      • No adjudication method (like 2+1 or 3+1 expert review) is mentioned for establishing the ground truth from GC/MS or LC/MS. These instrumental methods provide quantitative results that are then categorized as positive or negative based on the cutoff concentration. The "agreement" between the device and the GC/MS/LC/MS result serves as the primary metric.
      • For the reproducibility study, three operators performed the testing, suggesting a comparison of their readings rather than an adjudication process for ground truth.
      • For the method comparison study, "Three operators performed the testing. Each operator tested one device format with one unique set of blind coded samples." This points to individual operator readings against the GC/MS ground truth, not an adjudication process among operators to define the ground truth.

    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 MRMC comparative effectiveness study was done. This device is a rapid lateral flow immunoassay (a diagnostic test kit), not an AI-assisted diagnostic device. The "readers" are the individuals interpreting the visible lines on the dip card/cup/cassette. The "lay-user study" involves human interpretation, but it's not framed as a comparative effectiveness study with vs. without AI assistance.

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

      • This is a diagnostic test kit with a visual readout, where a human interprets the presence or absence of lines. Therefore, there is no "algorithm only" or "standalone" performance in the context of AI. The device itself is standalone in that it provides a result without additional complex equipment beyond the collection of urine. However, the interpretation is human-in-the-loop.

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

      • The primary ground truth used was analytical confirmation by Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS). These are considered the gold standard for confirming the presence and concentration of drugs in urine.

    7. The sample size for the training set:

      • The document describes performance studies for new analytes (BUP and TCA) and mentions that existing analytes were cleared under previous 510(k)s. It does not explicitly state a "training set" size in the context of machine learning or algorithm development. These are immunoassay test kits, and their "training" is in their design, manufacturing, and calibration processes. The presented data represents validation studies, which are analogous to a test set in machine learning.

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

      • As there isn't a "training set" in the machine learning sense for this type of device, the concept of establishing ground truth for it doesn't directly apply. The immunoassay is designed based on known chemical reactions and antibody-antigen binding. The validation studies (reproducibility and method comparison) then verify its performance against the analytically confirmed presence or absence of drugs (GC/MS/LC/MS as ground truth).
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