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510(k) Data Aggregation

    K Number
    K101574
    Device Name
    ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
    Manufacturer
    ARK DIAGNOSTICS,INC
    Date Cleared
    2010-11-23

    (169 days)

    Product Code
    OTF,DLJ,LAS
    Regulation Number
    862.3350
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K083799
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ARK™ Gabapentin Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of gabapentin in human serum or plasma on automated clinical chemistry analyzers. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.

    The ARKTM Gabapentin Calibrator is intended for use in calibration of the ARK Gabapentin Assay.

    The ARKTM Gabapentin Control is intended for use in quality control of the ARK Gabapentin Assay.

    Device Description

    The ARK Gabapentin Assay is a homogeneous immunoassay based on competition between drug in the specimen and gabapentin labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly proportional to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenyzme NAD functions only with the bacterial enzyme used in the assay.

    The ARK Gabapentin Assay consists of reagents R1 anti-gabapentin polyclonal antibody with substrate and R2 gabapentin labeled with bacterial G6PDH enzyme. The ARK Gabapentin Calibrator consists of a six-level set to calibrate the assay, and the ARK Gabapentin Control consists of a three-level set used for quality control of the assay.

    ARK Gabapentin products contain ≤0.09% sodium azide. As a precaution, affected plumbing should be flushed adequately with water to mitigate the potential accumulation of explosive metal azides. No special handling is required regarding other assay components.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study findings for the ARK™ Gabapentin Assay, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance CriteriaReported Device Performance
    Limit of Quantitation (LOQ)≤20% CV with ±15% recovery0.75 µg/mL (demonstrated acceptable inter-assay precision and recovery)
    Recovery / AccuracyNot explicitly stated as a defined criterion (implied by typical assay validation standards that recovery should be close to 100% within a certain range).Mean percent recovery: 100.9% across concentrations from 1.0 to 40.0 µg/mL.
    LinearityPercent difference between predicted 1st and 2nd order regressed values of ±10%, or ±15% for concentrations ≤ 1.0 µg/mL.Linear relationship demonstrated between 0.75 and 48.0 µg/mL. All points met the ±10% or ±15% (for lower concentrations) difference criteria. (e.g., 0.75 µg/mL: 12.0% difference; 1.0 µg/mL: 8.4% difference; all others below 2.2% difference up to 48 µg/mL).
    Assay RangeNot explicitly stated as an acceptance criterion for the range itself, but the device performance defines the reportable range.0.75 to 40.0 µg/mL.
    Method Comparison (Correlation)Implied by the use of Passing-Bablok regression: a slope close to 1, y-intercept close to 0, and a high correlation coefficient (r²) indicating strong agreement with reference methods.Study 1 (LC-MS/MS): Slope 0.96 (0.92 to 0.99), y-intercept -0.06 (-0.28 to 0.18), r² 0.96 (0.95 to 0.97). Study 2 (HPLC): Slope 1.08 (1.03 to 1.13), y-intercept -0.08 (-0.35 to 0.25), r² 0.97 (0.95 to 0.98). Study 3 (LC-MS/MS): Slope 1.13 (1.08 to 1.17), y-intercept 0.31 (0.06 to 0.52), r² 0.98 (0.97 to 0.99).
    Precision<10% total CVARK Gabapentin Control: Low 5.6%, Mid 4.4%, High 3.6% (total CV). Human Serum: Low 7.7%, Mid 4.6%, High 4.7% (total CV). All met the <10% total CV criterion.
    Interfering SubstancesMeasurement of gabapentin resulted in ≤10% error in the presence of interfering substances at the levels tested.All tested substances (Albumin, Bilirubin Conjugated/Unconjugated, Cholesterol, Gamma-Globulin, Hemoglobin, Intralipid®, Rheumatoid Factor, Triglycerides, Uric Acid) resulted in percentage recovery between 95.2% and 106.6% (i.e., within 10% error) for gabapentin concentrations of 2 µg/mL and 20 µg/mL.
    Drug InterferenceMeasurement of gabapentin resulted in ≤10% error in the presence of drug compounds at the levels tested.Most tested anti-epileptic or co-administered drugs and L-amino acids showed percentage recovery within 10% error (between 90% and 110%) for both 2 µg/mL and 20 µg/mL gabapentin. Note: Pregabalin showed higher cross-reactivity at high concentrations (e.g., 100 µg/mL Pregabalin led to 156.9% recovery at 2 µg/mL Gabapentin). The document notes that "Care should be taken when interpreting ARK Gabapentin results if pregabalin is also being administered."
    AnticoagulantsNot explicitly stated as a numerical criterion, but implies no significant difference."The results indicate that there is no significant difference between the recovery of gabapentin in serum or plasma."
    Sample StabilityFresh specimens preferred. Clarified specimens: up to one week at 2-8°C. Frozen (≤ -10°C): up to four weeks (acceptance criterion ± 10%). Withstand 3 freeze-thaw cycles.Specimens shown to meet these criteria.
    On-Board Stability (Calibration Curve)Up to 84 days.Effective up to 84 days based on supporting data.
    On-Board Stability (Reagent)Up to at least 84 days.Effective up to at least 84 days based on supporting data.
    Accelerated OPEN stability of calibrators and controlsCalibrators and controls stable OPEN at 37℃ for seven (7) days. Once opened: 12 months at 2-8℃.Shown to be stable per criteria.

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

    • Recovery: Not explicitly stated how many unique samples were tested, but "Six replicates of each sample were assayed." The samples were "human serum negative for gabapentin" spiked with pure gabapentin. Provenance: Not specified (retrospective/prospective, country of origin).
    • Linearity: Not explicitly stated how many unique samples, but dilutions were made from a 48.0 µg/mL serum sample. Provenance: Not specified.
    • Method Comparison:
      • Study 1: 183 samples. Provenance: Not specified.
      • Study 2: 64 samples. Provenance: Not specified.
      • Study 3: 49 samples. Provenance: Not specified.
    • Precision: 160 measurements were taken for each of the three control levels and three human serum pooled specimens (quadruplicate, twice a day for 20 days). Provenance: Not specified.
    • Interfering Substances: For each interfering substance, samples were prepared with gabapentin at approximately 2 µg/mL and 20 µg/mL, and assayed against a serum control. The number of individual samples (beyond the spiked ones) isn't specified. Provenance: Not specified.
    • Drug Interference: Similar to interfering substances, samples were prepared with gabapentin at approximately 2 µg/mL and 20 µg/mL, spiked with high concentrations of various drugs, and assayed against a serum control. Provenance: Not specified.
    • Anticoagulants: "Studies were conducted to determine the performance characteristics of the assay for both serum and plasma samples." Specific sample sizes not provided. Provenance: Not specified.
    • Sample Stability: Specific sample sizes not provided, but studies addressed various storage conditions and freeze-thaw cycles. Provenance: Not specified.

    It is common for these types of in vitro diagnostic device submissions for a new assay to describe the preparation of test materials and not necessarily the specific provenance of every human sample component (e.g., general "human serum").

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

    This type of in vitro diagnostic device (quantitative immunoassay) does not typically involve human experts for establishing "ground truth" in the way an imaging AI device would. Instead, the "ground truth" for the performance studies described is established by:

    • Reference methods: For method comparison, reference standards like LC-MS/MS and HPLC are used to define the true concentration of gabapentin in samples. These are highly accurate analytical techniques, not human expert consensus.
    • Spiking studies: For recovery, linearity, interference, and drug interference, known quantities of high-purity gabapentin or interfering substances are added to negative serum/plasma, establishing a precise theoretical "ground truth" concentration.

    Therefore, the concept of "number of experts" and their "qualifications" for ground truth determination is not applicable in this context.

    4. Adjudication Method for the Test Set

    Not applicable. As explained above, the ground truth is established by analytical reference methods or known spiked concentrations, not by human interpretation or 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

    Not applicable. This device is a quantitative immunoassay for measuring drug concentration in blood, not an imaging device or a diagnostic aid that would involve human "readers" or AI assistance in interpretation.

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

    Yes, the studies described are all "standalone" in nature, as they assess the performance of the assay itself (the "algorithm only" in a broader sense of an analytical method) to accurately measure gabapentin concentrations. The output of the device is a quantitative value (gabapentin concentration in µg/mL), which is then used by clinicians. There is no "human-in-the-loop performance" component for how the assay itself functions.

    7. The Type of Ground Truth Used

    The ground truth for the performance studies was established using:

    • Reference analytical methods: High Performance Liquid Chromatography - Mass Spectrometry (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) were used as reference methods for the method comparison studies.
    • Spiked samples: For recovery, linearity, interference, and drug interference studies, known, precise amounts of pure gabapentin or interfering substances were added to gabapentin-negative human serum/plasma to create samples with known theoretical concentrations.

    8. The Sample Size for the Training Set

    Not applicable. This is an immunoassay, not a machine learning or AI algorithm in the contemporary sense that would involve a "training set" for model development. The development of the assay (e.g., antibody selection, reagent formulation) is a traditional chemical and biological process, not a computational learning process with distinct training and test sets.

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

    Not applicable, as there is no "training set" in the context of this immunoassay.

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