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510(k) Data Aggregation

    K Number
    K182103
    Device Name
    Psychemedics Microplate EIA for Fentanyl in Hair
    Manufacturer
    Psychemedics Corporation
    Date Cleared
    2019-04-18

    (258 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    k111926
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Psychemedics Microplate EIA For Fentanyl in Hair is an in vitro diagnostic device for the qualitative detection of fentanyl in hair. The assay is intended for use in workplace settings for the qualitative analysis of human head and body hair. The assay uses a cutoff calibrator of 0.2 ng fentanyl/10 mg hair.

    Psychemedics plans to perform this test at one site. Psychemedics has not performed an evaluation of reproducibility at different laboratories.

    The Psychemedics Microplate EIA For Fentanyl in Hair provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS) using deuterated internal standards in multiple reaction monitoring (MRM) mode is the confirmatory method used by Psychemedics Corporation. This confirmatory method uses a cutoff of 0.2 ng of fentanyl/10 mg hair.

    Device Description

    The Psychemedics Microplate EIA For Fentanyl in Hair consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Fentanyl. The screening portion of the test system consists of (1) microplate wells coated with fentanyl conjugated to bovine serum albumin (BSA), monoclonal rabbit anti-fentanyl, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the supporting study for the Psychemedics Microplate EIA for Fentanyl in Hair device:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    PrecisionIntra-Assay and Inter-Assay Precision around cutoffIntra-Assay Precision:- B₀ (-100%): 10 negative, 0 positive- -75%: 10 negative, 0 positive- -50%: 10 negative, 0 positive- -25%: 10 negative, 0 positive- Plus 25%: 0 negative, 10 positive- Plus 50%: 0 negative, 10 positive- Plus 75%: 0 negative, 10 positive- Plus 100%: 0 negative, 10 positiveInter-Assay Precision:- B₀ (-100%): 50 negative, 0 positive- -75%: 50 negative, 0 positive- -50%: 50 negative, 0 positive- -25%: 50 negative, 0 positive- Plus 25%: 0 negative, 50 positive- Plus 50%: 0 negative, 50 positive- Plus 75%: 0 negative, 50 positive- Plus 100%: 0 negative, 50 positive
    Comparison TestingNo False Negatives relative to LC/MS/MSNo false negative EIA results occurred relative to LC/MS/MS.
    Limited False Positives relative to LC/MS/MS at cutoff.Ten positive EIA results did not confirm at or above the 0.2 ng fentanyl/10 mg hair cutoff by LC/MS/MS due to washing effects or cross-reactivity with other fentanyl compounds.
    Cross-ReactivityExpected cross-reactivity for related compounds, no cross-reactivity for unrelated compounds.- Fentanyl and several analogs (Butyryl, Valeryl, Furanyl, Acetyl, o-Fluorofentanyl, Acryl, Cyclopropyl, Isobutyryl, Ocfentanil, 4-Fluoro-isobutyryl) showed high cross-reactivity (100% to 200%).- Other related compounds show lower cross-reactivity (e.g., (+/-)-cis-3-methylfentanyl at 9.1%, Methyl fentanyl at 2%).- Many unrelated compounds (e.g., stimulants, opiates, benzodiazepines, cannabinoids, etc.) showed no cross-reactivity.
    InterferenceNo significant interference from commonly found substances.A wide range of specified compounds (e.g., amoxicillin, caffeine, ibuprofen, naproxen, various illicit drugs like cocaine, heroin metabolites) and mixes showed no interference in the Fentanyl EIA assay.
    Cosmetic TreatmentsEIA results for negative and positive samples are unaffected by cosmetic treatments (bleach, perm, dye, relaxer, shampoo).- Negative hair samples remained negative after bleach, permanent wave, dye, relaxer, and shampoo treatments.- For positive samples, fentanyl concentration change ranged from 98.4% (shampoo) to 106.5% (relaxer) of untreated samples for dye, relaxer, shampoo, and perm, indicating no significant loss or false positivity.
    Environmental ContaminationEnvironmental contamination does not lead to false positives above cutoff after washing procedure.After an extensive washing procedure, samples contaminated with 2 ng fentanyl/mL of saline resulted in concentrations from below LOQ to 0.0527 ng/10 mg hair, which is well below the 0.2 ng/10 mg hair cutoff.
    Sample StabilityFentanyl in hair samples remains stable during shipping and storage.Five samples showed no significant differences between results before and after shipping and one month of storage.
    Recovery (EIA)Sufficient recovery of fentanyl after hair digestion.Recovery of fentanyl in the digestion method was shown to be at least 80% complete at 2 hours.
    Recovery (LC/MS/MS)High recovery of fentanyl and norfentanyl from hair.Recovery of fentanyl and norfentanyl from 5 authentic samples was greater than 96%. Recoveries of analytes and internal standards with SPE were greater than 50% with <5% CV precision. Averages of 5 samples were 98 - 102% of target concentrations.
    LC/MS/MS Precision (around cutoff and over range)Acceptable precision for LC/MS/MS results.All sets of replicates had < 10% CV. Averages of all replicates were within 15% of target concentration.
    LC/MS/MS LinearityLinearity across the assay range.Demonstrated from 0.01 to 7.5 ng/10 mg hair. All results were within 15% of target concentrations. Agreement of 5 determinations at each concentration was < 10% CV. Regression coefficient > 0.995. Actual data points deviated < 10% from regression line.
    Validity of Dilution (LC/MS/MS)Accurate results upon dilution.Agreement of 5 determinations was < 10% CV. Averages of 5 determinations at each dilution were within 15% of target values.
    Carryover (LC/MS/MS)No carryover at the upper limit of linearity (ULOL).No signal was detected in negative samples following 7.5 ng/10 mg hair samples, indicating no carryover up to 7.5 ng/10 mg hair.
    Matrix Effects (LC/MS/MS)No significant ion suppression or enhancement.No ionization suppression or enhancement greater than +/- 15% was observed.
    Interference from Internal Standard/Analytes (LC/MS/MS)No cross-contamination between deuterated and non-deuterated compounds.No peaks detected in the D5 window for samples without internal standard (D3), and no peaks detected in the D0 window for samples without analytes.
    Interference from other compounds (LC/MS/MS)No interference from a broad panel of other compounds.No interference detected from 37 individual compounds and 38 compounds in 5 mixes.
    Accuracy (LC/MS/MS)Accurate measurements demonstrated through proficiency testing and statistical analysis.Proficiency testing samples were near target concentrations and within the range of other participating labs. Linearity and precision data support accuracy (averages within 15% of target). LLOQ determined at 0.01 ng/10 mg hair with adequate S:N ratios. Reproducibility across multiple hair types showed >90% of target and <10% CV.

    Study Information: Psychemedics Microplate EIA for Fentanyl in Hair

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

      • Test Set Sample Size: 197 samples (comprising both head and body hair) were used for comparison testing against the confirmatory method.
      • Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using collected hair samples.

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

      • This is a laboratory diagnostic device that performs an analytical test. The ground truth is established by a more specific alternative chemical method, not by human expert interpretation.
      • The "ground truth" for the test set was established by Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS), which is the confirmatory method. Clinical laboratory personnel perform these tests, not "experts" in the sense of physicians interpreting images.

    3. Adjudication method for the test set:

      • Not applicable in the traditional sense of human adjudication for classification tasks. The adjudication is done by comparing the screening EIA results to the LC/MS/MS confirmatory results. Any discrepancies (e.g., EIA positive, LC/MS/MS negative) are analyzed for root cause (e.g., washing effects, cross-reactivity).

    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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a diagnostic assay (EIA followed by LC/MS/MS), not an AI-assisted diagnostic tool that requires human interpretation.

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

      • Yes, the performance presented for the Psychemedics Microplate EIA for Fentanyl in Hair is entirely standalone (algorithm/assay only). The EIA provides a preliminary analytical test result without human interpretation of the assay itself being a variable. The human "in-the-loop" would be the laboratory technician performing the assay and subsequently the LC/MS/MS confirmation, but the performance metrics are for the assay's ability to accurately detect fentanyl.

    6. The type of ground truth used:

      • The primary ground truth for the comparison study was Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS) results. This is considered the definitive analytical method for confirming the presence and concentration of fentanyl in hair samples.

    7. The sample size for the training set:

      • This is a traditional diagnostic assay, not a machine learning model. Therefore, there isn't a "training set" in the context of an AI/ML algorithm. The performance testing involves samples used for validation, but not in the sense of training a model.
      • Calibrators and controls: The calibrators and control materials are prepared from commercially purchased stocks, and their concentrations are confirmed by LC/MS/MS. These are established analytical standards, not a training set for an algorithm.

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

      • As this is not an AI/ML device, the concept of a "training set ground truth" does not apply. The calibrators and controls' "ground truth" (i.e., their known concentrations) are established by highly accurate methods like LC/MS/MS using specific certificates of analysis for the drug stocks.
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