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    K Number
    DEN210056

    Validate with FDA (Live)

    Device Name
    Procise IFX
    Manufacturer
    ProciseDx Inc.
    Date Cleared
    2023-09-29

    (660 days)

    Product Code
    QXT
    Regulation Number
    862.3115
    Type
    Direct
    Panel
    Toxicology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab levels in venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer.

    Measurements obtained by this assay can be used to detect infliximab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with infliximab. The test is intended for use in a clinical laboratory.

    Device Description

    Each Procise IFX assay kit includes Procise IFX reagent cartridges, buffer bulbs, and Procise IFX low and high assay controls as follows:

    • Twenty pouched Procise IFX cartridges each containing a lyophilized test-specific reagent bead contains a dry reagent bead located in the cartridge cap comprised of < 50 ug of test-specific conjugates (monoclonal Fab anti-IFX/TNFa complex labeled with acceptor fluorophore and TNFa labeled with donor fluorophore)
    • Twenty 1.5mL buffer bulbs .
    • Two pouched assay IFX Low controls
    • Two pouched assay IFX High controls .
    • Product Insert
    • Quick Reference Guide .

    The Procise IFX assay requires the ProciseDx Analyzer. The ProciseDx Analyzer is designed to detect time-resolved fluorescent signal from both the donor and FRET acceptor emission within the Procise IFX assay.

    AI/ML Overview

    The provided text describes the analytical performance characteristics of the Procise IFX assay, which is a quantitative immunoassay for measuring infliximab levels. This is an in vitro diagnostic device, and thus the acceptance criteria and supporting studies are focused on analytical performance rather than clinical performance based on human reader interpretation. Therefore sections relating to human reader studies (MRMC, expert number/qualifications, adjudication) are not applicable.

    Here's a summary of the acceptance criteria and the studies that prove the device meets them:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance." Instead, it describes various performance studies and their results, which implicitly demonstrate that the device meets acceptable analytical standards for an in vitro diagnostic. Based on the provided data, the implicit acceptance criteria would be for the device to demonstrate robust performance across key analytical metrics.

    Performance MetricAcceptance Criteria (Implicit)Reported Device Performance
    PrecisionLow %CV across a range of IFX concentrations and various conditions.20-Day Precision: Total %CV ranged from 5.2% to 10.6% across 5 IFX concentrations (2.37-43.77 µg/mL). Reproducibility (3 external sites): Total %CV ranged from 5.3% to 7.0% across 5 IFX concentrations (2.86-37.46 µg/mL).
    LinearitySamples within the measuring range demonstrate linear correlation.Reported: Slope = 1.07, Intercept = -0.21, R² = 0.9992 for a sample range of 0.6-80 µg/mL, supporting the claimed measuring range of 1.2-50 µg/mL.
    Analytical SpecificityNo significant interference from common substances.No significant interference (bias ≤10%) observed from 21 tested compounds at specified concentrations, including other drugs, metabolites, and endogenous substances (e.g., Adalimumab, Bilirubin, Hemolysate, Human Anti-Mouse Antibody, Rheumatoid Factors).
    High Dose Hook EffectNo hook effect up to a certain high concentration.Results unimpacted by a hook effect at IFX concentrations of up to 300 µg/mL. For results >50 µg/mL, the analyzer displayed ">50 µg/mL".
    Assay Reportable RangeClearly defined and supported by data.1.2 to 50.0 µg/mL (supported by linearity study).
    TraceabilityTraceable to a recognized international standard.Calibrators traceable to IFX WHO International Standard: 1st International Standard for Infliximab (NIBSC code: 16/170). Recovery study showed good correlation (Pearson's R of 1.00) and low %Bias (mostly within ±10%) compared to the WHO IS Standard for IFX.
    Sample StabilityAcceptable stability under various storage conditions.Room Temperature & Refrigerated: 3 days stability (supported for 3 patients). Frozen: Stable up to 142 weeks at -80°C (for 37 patients). Freeze-Thaw: Stable up to 5 freeze-thaw cycles at -80°C (for 5 samples).
    Detection LimitClearly defined LOB, LOD, and LOQ.LoB: 0.08 µg/mL. LoD: 0.28 µg/mL. LoQ: 1.2 µg/mL (at 33% total error).
    Method ComparisonGood correlation with existing validated methods.Comparator 1 (N=53): Slope = 1.04, Intercept = -0.84, Correlation Coefficient (r) = 0.97. Comparator 2 (N=53): Slope = 0.99, Intercept = -0.50, Correlation Coefficient (r) = 0.99. Comparator 3 (N=77): Slope = 1.05, Intercept = 1.26, Correlation Coefficient (r) = 0.98.
    Biosimilar DetectionAccurately detects biosimilar drugs.Inflectra: % Bias ranged from -3% to 3% across 7 concentrations. Renflexis: % Bias ranged from -7% to 3% across 7 concentrations.

    2. Sample sizes used for the test set and the data provenance

    • Precision/Reproducibility:
      • 20-Day Precision: 5 pools of native serum samples, each tested in 240 replicates (replicates of two, two times per day, for twenty days).
      • Reproducibility (External Sites): 5 serum samples (3 pools of native serum, 2 QC samples). Each sample tested in 3 replicates, two times per day, for five days at 3 external sites.
    • Linearity: 13 different IFX levels created from native serum samples.
    • Analytical Specificity/Interference: Pooled IFX negative serum combined with native IFX serum samples at approximately 2.5, 4, and 7 µg/mL, plus each interferent at twice CLSI recommended levels.
    • High Dose Hook Effect: Serum samples at 5 IFX concentrations (25, 50, 100, 200, 400 µg/mL), tested in 5 replicates.
    • Traceability/Recovery Study: 11 dilutions of WHO IS Standard for IFX created using native IFX negative serum, tested in triplicates.
    • Sample Stability:
      • Room Temp & Refrigerated: Freshly drawn serum from 3 patients.
      • Frozen: Freshly drawn serum from 37 patients.
      • Freeze-Thaw: 5 frozen serum samples.
    • Detection Limit:
      • LoB: 4 native serum specimens (no IFX), tested in 5 replicates over 3 days (60 measurements/lot).
      • LoD: 4 different IFX samples (0.1, 0.2, 0.4, 0.5 µg/mL), tested in 5 replicates across 3 days (60 measurements/lot).
      • LoQ: 4 samples above LOD (0.5, 0.7, 0.9, 1.2 µg/mL), tested in 5 replicates across 3 days (60 measurements/lot).
    • Method Comparison:
      • 53 deidentified serum samples for comparison with Comparators 1 and 2.
      • 77 additional serum samples for comparison with Comparator 3.
    • Biosimilar Detection: Pooling IFX negative human serum to create 7 different levels each of Infliximab, Inflectra, and Renflexis, tested in 6 replicates.

    Data Provenance: The document generally refers to "native serum samples" and "freshly drawn serum from patients." The absence of specific country of origin or explicit statements about being prospective/retrospective for all samples implies the data is likely a mix, but importantly, the studies focus on analytical performance using human serum samples. Given the context of an FDA de novo request for an in vitro diagnostic, the data is typically considered highly controlled and collected for the purpose of demonstrating analytical performance. The use of "deidentified serum samples" for method comparison suggests retrospective use or collection for research purposes where patient identity is removed.

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

    Not applicable. This device is an in vitro diagnostic for quantitative measurement of a biomarker (infliximab) and does not involve human interpretation of images or clinical cases that would require expert consensus for ground truth. The ground truth for analytical studies is typically established by reference methods, known concentrations, or certified reference materials (like the WHO International Standard).

    4. Adjudication method for the test set

    Not applicable. As noted above, this device measures a quantitative biomarker and does not involve subjective human interpretation or diagnostic decisions that would require 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 is an in vitro diagnostic device, not an AI-assisted diagnostic tool requiring human reader involvement.

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

    Yes, this is effectively a standalone device (algorithm only without human-in-the-loop performance in terms of diagnostic interpretation). The "ProciseDx Analyzer" automatically measures the FRET signal and determines the IFX concentration based on the ratio of emissions. Its performance is entirely characterized by its analytical capabilities, as detailed in the performance characteristics section.

    7. The type of ground truth used

    The ground truth for the analytical studies was primarily established using:

    • Reference Standards: For traceability, the Procise IFX assay calibration standards are traceable to the IFX WHO International Standard (NIBSC code: 16/170). Known concentrations derived from this standard served as ground truth for recovery and accuracy.
    • Validated Comparator Methods: For method comparison studies, three existing validated comparator methods were used to establish the comparative ground truth.
    • Known Concentrations: For precision, linearity, interference, hook effect, and biosimilar detection studies, samples were prepared with known or targeted IFX concentrations, allowing for direct comparison of the device's measurements against these pre-defined values.
    • Native Serum Samples: For various studies, native human serum samples were used to represent real-world clinical samples.

    8. The sample size for the training set

    The document does not explicitly delineate a "training set" in the context of machine learning or AI algorithm development. For an in vitro diagnostic device like the Procise IFX assay, the "training" for the assay's performance characteristics (e.g., calibration curves, reagent optimization) is inherent in the assay development and validation processes, which typically involve extensive testing with various concentrations and sample types, often using reference materials and clinical samples. This is represented by the multiple studies and samples outlined under the "Performance Characteristics" section.

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

    Similar to point 8, the concept of a "training set" with distinct ground truth establishment for an AI algorithm is not directly applicable. However, the development of the assay's fundamental operating parameters and calibration (i.e., the "training" the device undergoes to produce accurate results) relies on rigorous analytical studies using:

    • WHO International Standard: As mentioned, the traceability section indicates the use of the IFX WHO International Standard, which would be crucial for establishing the quantitative relationship between the assay's signal and actual infliximab concentration.
    • Defined Prepared Samples: The linearity, precision, and other analytical studies use samples prepared with known concentrations of infliximab, which serve as the ground truth for characterizing the assay's performance across its measuring range.
    • Existing Validated Methods: Comparison to established methods helps ensure that the new assay's measurements are consistent with accepted quantitative approaches.
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    K Number
    DEN220023

    Validate with FDA (Live)

    Device Name
    Procise ADL
    Manufacturer
    ProciseDx Inc.
    Date Cleared
    2023-09-29

    (543 days)

    Product Code
    QYD
    Regulation Number
    862.3115
    Type
    Direct
    Panel
    Toxicology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Procise ADL assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of adalimumab (ADL) levels in venous serum in patients undergoing adalimumab therapy, using the ProciseDx Analyzer.

    Measurements obtained by this assay can be used to detect adalimumab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with adalimumab. The test is intended for use in a clinical laboratory.

    Device Description

    Each Procise ADL assay kit includes Procise ADL reagent cartridges, buffer bulbs, and Procise ADL low and high assay controls as follows:

    • . Twenty pouched Procise ADL cartridges each containing a lyophilized test-specific reagent bead located in the cartridge cap comprised of test-specific conjugates (monoclonal Fab anti-ADL/TNFa complex labeled with acceptor fluorophore and TNFa protein labeled with donor fluorophore)
    • Twenty 1.5 mL buffer bulbs .
    • . Two pouched assay ADL Low controls
    • . Two pouched assay ADL High controls
    • Product Insert .
    • . Quick Reference Guide

    The Procise ADL assay requires the ProciseDx Analyzer. The ProciseDx Analyzer is designed to detect time-resolved fluorescent signal from both the donor and FRET acceptor emission within the Procise ADL assay.

    AI/ML Overview

    Acceptance Criteria and Study Proving Device Meets Criteria for Procise ADL Assay

    The Procise ADL assay is a quantitative, time-resolved fluorescence energy transfer immunoassay for measuring adalimumab (ADL) levels in patient serum, intended to aid in the management of inflammatory bowel disease (IBD) patients undergoing adalimumab therapy. As the provided document is a De Novo Decision Summary from the FDA, it outlines the review of the analytical performance studies conducted by the manufacturer, rather than a clinical trial with acceptance criteria for clinical efficacy. Therefore, the "acceptance criteria" here refer to the predefined performance goals the analytical studies needed to meet for FDA authorization.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance Metric CategorySpecific MetricAcceptance Criteria (Implicit from Study Design/Results Presented)Reported Device Performance and How it Meets Criteria
    Precision/ReproducibilityTotal %CV for within-laboratory precision (20-Day)Generally, %CV below a certain threshold (e.g., typically <10-15% for quantitative assays, varying with concentration). Specific thresholds not explicitly stated but inferred from passing results.Sample 1 (2.47 µg/mL): Total %CV = 10.6% Sample 2 (5.79 µg/mL): Total %CV = 6.8% Sample 3 (10.22 µg/mL): Total %CV = 6.1%Sample 4 (12.71 µg/mL): Total %CV = 7.3%Sample 5 (45.79 µg/mL): Total %CV = 5.2% All total %CVs are within acceptable limits for a quantitative assay.
    Total %CV for inter-site reproducibilitySimilar to within-laboratory precision, acceptable %CV across multiple sites.QC Low (3.20 µg/mL): Total CV (%) = 7.0QC High (22.77 µg/mL): Total CV (%) = 7.2Sample 1 (5.18 µg/mL): Total CV (%) = 6.2Sample 2 (9.77 µg/mL): Total CV (%) = 6.1Sample 3 (44.32 µg/mL): Total CV (%) = 8.9 All total %CVs are within acceptable limits across multiple sites.
    LinearityPercent deviation from linearityWithin ±5% across the reportable range.Native Samples: Percent deviation from linearity was within ±5% across the range tested (0.5 - 74.9 µg/mL). For the claimed measuring range of 1.0-50 µg/mL, the linear regression yielded a Slope of 0.98, Intercept of 0.28, and R^2 of 0.9995. This demonstrates excellent linearity across and beyond the claimed reportable range.
    Analytical Specificity/InterferenceBias due to interferentsBias ≤10% for each potential interferent and concentration level tested compared to the nominal condition.None of the 21 tested substances (including common drugs, endogenous substances, and anti-drug antibodies to ADL and infliximab) showed significant interference (bias ≤10% at relevant concentrations, often at or above physiological/therapeutic levels). The assay demonstrates good analytical specificity, with limitations appropriately noted for highly hemolyzed or icteric samples.
    High-Dose Hook EffectAbsence of hook effectResults unimpacted by a hook effect for concentrations up to 300 µg/mL.Serum samples tested at ADL concentrations of approximately 25, 50, 100, 200, and 300 µg/mL. For results above the upper limit of quantification (50 µg/mL), the analyzer displayed ">50 µg/mL". Device results were unimpacted by a hook effect up to 300 µg/mL. This confirms that very high ADL levels will not cause a falsely low reading within the tested range, providing a crucial safety feature.
    Assay Reportable RangeDefined measuring rangeEstablish a range from 1.0 to 50.0 µg/mL based on linearity and other analytical performance.The assay reportable range was established as 1.0 to 50.0 µg/mL. This is supported by linearity, precision, and detection limit studies. The studies confirm the device's ability to accurately quantify ADL within this range.
    TraceabilityTraceability to WHO IS StandardCalibration standards traceable to the ADL WHO International Standard (NIBSC code: 17/236). Recovery study to demonstrate functional accuracy.Calibration standards are traceable to the ADL WHO International Standard. A recovery study with the WHO IS Standard demonstrated good agreement: Slopes of 0.99-1.03 and R^2 of 1.00 for individual replicates. Individual percent biases ranged from -4% to 21%, with most at lower percentages, particularly away from the lower detection limits. This validates the accuracy and standardization of the assay's measurements.
    Sample StabilityStability at various conditionsSupport for labeling claims regarding stability at room temperature, refrigerated, frozen (-80°C), and multiple freeze-thaw cycles.Room Temp/Refrigerated: Supported 3 days stability. Frozen (-80°C): Supported up to 142 weeks stability. Freeze-Thaw: Supported up to 5 freeze-thaw cycles. These studies ensure the reliability of results given various sample handling conditions in a clinical laboratory setting.
    Detection LimitsLoB, LoD, LoQLoB, LoD, and LoQ determined based on CLSI EP17-A2 guidelines. For LoQ, total error <35%.LoB: 0.08 µg/mL LoD: 0.25 µg/mL LoQ: 0.96 µg/mL (with <35% total error). These values define the lower limits of reliable measurement for the assay.
    Method ComparisonCorrelation with comparator methodsStrong correlation (e.g., Pearson r > 0.95 or 0.98) and acceptable agreement (slope close to 1, intercept close to 0) with validated comparator methods.N=61 samples compared to a representative comparator method. Slope = 0.91, Intercept = 1.08 µg/mL, Correlation Coefficient (r) = 0.994. Sample range tested: 2.15-42.7 µg/mL. This demonstrates excellent agreement and correlation with existing validated methods, indicating the new assay provides comparable results.
    Biosimilar CompatibilityQuantitative equivalence in measuring Amjevita®Demonstrate quantitative equivalence in measuring the biosimilar drug Amjevita®. Linear regression coefficient of determination (R2) of 1.0.The assay demonstrated quantitative equivalence in measuring Amjevita® across seven concentrations (2.8 to 53.3 µg/mL). Individual % Bias ranged from -1% to 10% (excluding the highest point) and the linear regression coefficient of determination (R2) was 1.0. This confirms that the assay can accurately measure a key adalimumab biosimilar, broadening its clinical utility.

    2. Sample Sizes and Data Provenance

    • Test Set (Analytical Studies):

      • Precision (20-Day): 240 measurements per sample level (5 levels), resulting from 2 replicates/day x 2 times/day x 20 days x 3 lots/analyzers.
      • Reproducibility (Multi-site): Replicates of 3, 2 times/day, for 5 days by 2 operators using 2 instruments at each of 3 external sites, for 5 serum samples. Total number of data points not explicitly summed but substantial.
      • Linearity (Spiked Samples): 13 different ADL levels.
      • Linearity (Native Samples): 11 serum levels.
      • Analytical Specificity/Interference: Each of 21 interferents tested at 2 ADL concentrations (5 and 25 ug/mL).
      • High-Dose Hook Effect: 5 ADL concentrations, tested in replicates of five using three assay lots and three buffer bulb lots.
      • Procise ADL Assay Recovery Study (WHO IS Traceability): 11 dilutions of WHO IS Standard, tested in triplicates.
      • Sample Stability:
        • Room Temperature & Refrigerated: 3 patients (low, mid, high range ADL), tested in duplicate at baseline, Day 3, Day 5, Day 7; used 3 lots.
        • Frozen Serum: 33 patients, tested within a day of draw, then retested in duplicate after storage at -80°C.
        • Freeze-Thaw: 5 frozen serum samples (~3-40 ug/mL ADL), tested after 1, 2, 3, and 5 freeze-thaw cycles.
      • Detection Limits (LoB, LoD, LoQ):
        • LoB: 4 native serum specimens (no ADL), 5 replicates over 3 days using 2 lots (total 60 measurements per lot).
        • LoD: 4 ADL serum samples (0.1-0.5 ug/mL), 5 replicates across 3 days using 2 lots (total 60 measurements per lot).
        • LoQ: 4-5 samples, 5 replicates across 3 days using 2 lots (total 60-75 measurements per lot).
      • Method Comparison: 62 deidentified serum samples.
      • Biosimilar Compatibility: 7 concentrations of Amjevita® and ADL control, tested in replicates of six.

    • Data Provenance: The document does not specify the country of origin for the patient samples. All studies are described as analytical performance studies, which are typically retrospective in nature, using banked or collected human serum samples rather than real-time prospective clinical trials.

    3. Number of Experts and Qualifications for Ground Truth

    • Ground Truth for Analytical Studies: Not applicable in the same way as clinical studies. For quantitative in vitro diagnostic (IVD) devices like this, the "ground truth" for analytical performance tests is typically established by:
      • Known concentrations: For linearity, spike-in studies, and detection limit studies, precise dilutions of known standards (e.g., ADL WHO International Standard) are used.
      • Reference methods/comparators: For method comparison studies, the "ground truth" is established by results from already validated and established comparator methods.
      • Pooled samples / neat samples: For precision, stability, and interference, the "ground truth" is the established concentration of the pooled or neat human serum samples as measured by a reference method or confirmed by the manufacturer's internal processes.
    • Experts: No external experts (e.g., radiologists for imaging) are mentioned for establishing ground truth for these analytical performance studies. The studies are performed by laboratory personnel following established CLSI guidelines, implying the "experts" are the qualified laboratory scientists and statisticians who conduct and analyze the studies.

    4. Adjudication Method for the Test Set

    • Adjudication methods (e.g., 2+1 consensus) are typically used in clinical studies, especially those involving subjective interpretation of data (e.g., image reading).
    • For quantitative analytical performance studies of an IVD, explicit "adjudication" of results is not generally performed in the same manner. The data is quantitative, and performance is assessed statistically against predefined criteria based on CLSI guidelines. Any discrepancies would be investigated through root cause analysis rather than expert consensus on individual results.

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

    • No MRMC comparative effectiveness study was done.
    • This device is a quantitative in vitro diagnostic assay for a measurand (adalimumab levels), not an AI-assisted diagnostic imaging device that involves human reader interpretation. Therefore, a MRMC study or assessment of human reader improvement with AI assistance is not applicable. The device provides a direct quantitative measurement.

    6. Standalone (Algorithm Only) Performance

    • This is a standalone quantitative in vitro diagnostic device. Its performance is the algorithm's (assay's) performance. It does not involve human interpretation within its primary function where a human-in-the-loop scenario would be relevant for separate evaluation. The "ProciseDx Analyzer" is the instrument platform that runs the assay and displays the results.

    7. Type of Ground Truth Used

    The ground truth for the various analytical studies included:

    • Known concentrations/Spiking: For linearity, detection limits, high-dose hook effect, and biosimilar compatibility, samples were prepared with precisely known concentrations of ADL or ADL biosimilars by spiking into negative serum or by serial dilution from a concentrated stock.
    • Reference Standards: Specifically, the ADL WHO International Standard (NIBSC code: 17/236) served as the ultimate reference for traceability and accuracy verification.
    • Established Comparator Methods: For method comparison, previously validated and accepted clinical laboratory methods for measuring adalimumab served as the ground truth.
    • Native Patient Samples: Used for precision, stability, and interference studies, with their ADL concentrations determined by the assay itself or an established method as a baseline.

    8. Sample Size for the Training Set

    • The document describes analytical performance studies for assay validation, not a machine learning model that requires a distinct "training set" of data.
    • For an IVD assay, the "training" aspect is inherent in the assay's development and optimization process (e.g., reagent formulation, instrument calibration, algorithm for calculating concentration from raw signal), which is an iterative process often using a combination of characterized biological samples, synthetic samples, and controls. The specific sample size for this development phase is not detailed in a regulatory summary focused on validation.

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

    • Since there isn't a defined "training set" as in a machine learning context, the concept of establishing ground truth for it is not directly applicable.
    • The "ground truth" used during the development and optimization of such an assay would typically be established by:
      • Pharmacopoeial standards and reference materials: Highly characterized ADL raw materials and formulated drug products.
      • Gravimetric and volumetric preparations: Precisely prepared solutions and dilutions using analytical balances and calibrated pipettes to create samples with known ADL concentrations.
      • Well-characterized biological matrices: Pooled human serum from healthy donors or patients, characterized for background interference or spiked with known amounts of ADL.
      • Comparison to established research methods: During early development, comparison to gold standard research-level assays or mass spectrometry might be used to confirm initial assay performance.
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