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510(k) Data Aggregation

    K Number
    K151986
    Device Name
    ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Date Cleared
    2016-06-29

    (348 days)

    Product Code
    CDZ,JIT,JJX
    Regulation Number
    862.1680
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K151529,K093421,K140505,K091867
    Predicate For
    K190121,K191533
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ADVIA Centaur® Testosterone II (TSTII)

    The ADVIA Centaur Testosterone II (TSTII) assay is for in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the ADVIA Centaur XP system.

    Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

    ADVIA Centaur® Testosterone II (TSTII) Master Curve Material

    The ADVIA Centaur Testosterone II (TSTI) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Testosterone II (TSTII) assay.

    ADVIA Centaur® SHBG

    The ADVIA Centaur SHBG assay is an in vitro diagnostic immunoassay for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma using the ADVIA Centaur XP system.

    The ADVIA Centaur SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.

    ADVIA Centaur® SHBG Calibrator

    For in vitro diagnostic use in calibrating the ADVIA Centaur SHBG assay on the ADVIA Centaur systems.

    ADVIA Centaur® SHBG Master Curve Material

    The ADVIA Centaur SHBG Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur SHBG assay.

    Device Description

    The submission describes several components:

    ADVIA Centaur TSTII Assay Components: Includes ADVIA Centaur TSTII Primary Reagent ReadyPack (Lite Reagent and Solid Phase Reagent), ADVIA Centaur TSTII Ancillary Reagent ReadyPack (Releasing Agent), and ADVIA Centaur TSTII Calibrator (Low and High Calibrators). The ingredients are listed in Table 6.

    ADVIA Centaur TSTII Master Curve Material: Includes ADVIA Centaur TSTII MCM1 and MCM2-7. The ingredients are listed in Table 6.

    ADVIA Centaur SHBG Assay Components: Includes ADVIA Centaur SHBG Primary Reagent ReadyPack (Lite Reagent and Solid Phase Reagent), and ADVIA Centaur SHBG Ancillary Well Reagent. The ingredients are listed in Table 7.

    ADVIA Centaur SHBG Calibrator: Includes ADVIA Centaur SHBG Low and High Calibrators. The ingredients are listed in Table 7.

    ADVIA Centaur SHBG Master Curve Material: Includes ADVIA Centaur SHBG MCM1-5. The ingredients are listed in Table 8.

    The ADVIA Centaur TSTII assay uses a chemiluminescence competitive immunoassay methodology. The ADVIA Centaur SHBG assay uses a chemiluminescence sandwich immunoassay methodology. Both assays are intended for use on the ADVIA Centaur XP system.

    AI/ML Overview

    The provided document describes the acceptance criteria and study results for the ADVIA Centaur Testosterone II (TSTII) assay and the ADVIA Centaur SHBG assay.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Since the document does not explicitly present a table of predetermined acceptance criteria with a pass/fail column, I will infer the acceptance criteria from the context provided (e.g., studies performed and expected deviations/recoveries). The "Reported Device Performance" column will contain the results from the studies presented.

    ADVIA Centaur Testosterone II (TSTII) Assay:

    Performance CharacteristicInferred Acceptance Criteria (Based on typical IVD expectations and study narrative)Reported Device Performance
    PrecisionCVs generally <5-10% at relevant concentrationsRepeatability: 3.1-8.5% CV (Lowest at 768.74 ng/dL, highest at 10.58 ng/mL) Within-Lab: 4.5-12.6% CV (Lowest at 226.34 ng/mL, highest at 10.58 ng/mL)
    LinearityBias from linear fit estimate < 10% (or specified acceptable range)Bias from linear fit estimate: < 10% for most samples, up to 12.71% at the lowest end (6.72 ng/dL) Regression: Observed = 0.92(Expected) - 0.22 ng/dL
    Dilution RecoveryRecoveries within an acceptable range (e.g., 90-110%)Range: 93.9% to 114.2% Mean: 106.7%
    Method ComparisonGood correlation (r > 0.95) and minimal bias compared to reference method/predicateCDC HoSt Testosterone ID-LC-MS/MS: ADVIA Centaur TSTII = 0.97(ID-LC-MS/MS) + 1.94 ng/dL (r = 0.98) Dimension Vista TST (Adult & Pediatric): ADVIA Centaur TSTII = 1.01(Dimension Vista TST) + 0.99 ng/dL (r = 0.99) Dimension Vista TST (Pediatric): ADVIA Centaur TSTII = 1.04(Dimension Vista TST) + 0.22 ng/dL (r = 0.99)
    Matrix ComparisonNo significant difference or acceptable correlation between tube typesSlope: 0.94-0.98, Intercept: -1.61 to 4.50 ng/dL, r: 0.991-0.996 (No significant difference observed)
    Detection Limits (LoQ)LoQ should be clinically relevant and achievableLoQ: 7.00 ng/dL
    InterferenceAcceptable interference percentages for common interferentsHemoglobin (-0.4 to 5.8%), Triglycerides (-8.5 to 1.2%), Conjugated Bilirubin (-4.1 to 4.2%), Unconjugated Bilirubin (3.2 to 9.6%), Cholesterol (-9.4 to 6.4%), Rheumatoid Factor (0.7 to 4.6%). Biotin: 10% interference at 30 ng/mL. Conjugated Bilirubin: >15 mg/dL causes erroneous results (~-14.4% change at 20 mg/dL). Unconjugated Bilirubin: >20 mg/dL causes erroneous results (~20.1% change at 30 mg/dL).
    Heterophile InterferenceMean recovery close to 100% (e.g., 90-110%)Mean recovery for ~30 ng/dL: 98.69% Mean recovery for ~300 ng/dL: 94.55%
    Cross-ReactivitySpecificity for testosterone with minimal cross-reactivity from other steroidsVaried, with some substances showing higher cross-reactivity (e.g., 11β-Hydroxytestosterone, Ethisterone, Testosterone propionate). Specific percentages are provided in the table.

    ADVIA Centaur SHBG Assay:

    Performance CharacteristicInferred Acceptance Criteria (Based on typical IVD expectations and study narrative)Reported Device Performance
    PrecisionCVs generally <5-10% at relevant concentrationsRepeatability: 1.8-3.0% CV Within-Lab: 1.9-4.4% CV
    LinearityBias from linear fit estimate < 15% (or specified acceptable range)Bias from linear fit estimate: ≤15% across the range Regression: Observed = 0.984(Expected) + 0.245 ng/dL
    Dilution RecoveryRecoveries within an acceptable range (e.g., 90-110%)Range: 87% to 101% Mean: 92%
    Method ComparisonGood correlation (r > 0.95) and minimal bias compared to predicateADVIA Centaur SHBG = 0.99(Elecsys) - 0.11 nmol/L (r = 0.99)
    Detection Limits (LoQ)LoQ should be clinically relevant and achievableLoQ: 1.8 nmol/L

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

    • ADVIA Centaur Testosterone II (TSTII) Assay:

      • Precision: 5 serum patient pools, 3 control levels, 1 female patient serum specimen. Assayed twice a day in replicates of 2 for 20 days (n = 80 replicates per sample).
      • Linearity: 11 serially diluted samples. Each sample tested in duplicate.
      • Dilution Recovery: 5 serum samples.
      • Method Comparison:
        • Against CDC HoSt Testosterone ID-LC-MS/MS: 128 serum samples.
        • Against Dimension Vista Total Testosterone: 117 serum samples (adults) and 61 samples (pediatrics). The pediatric samples consisted of 27 females (age 7-18) and 34 males (age 9-18).
      • Matrix Comparison: Minimum of 50 matched specimens for each tube type (serum red top, serum separator tube, plasma separator tube, dipotassium EDTA, lithium heparin, and sodium heparin).
      • Reference Intervals:
        • Adults: 119-167 samples per group (Males Age <50, Males Age ≥50, Females Pre-Menopause, Females Post-Menopause).
        • Pediatrics: 20-130 samples per group (based on age and Tanner stage). Samples were collected prospectively from apparently healthy pediatric subjects.
      • Interference: Two sample pools (approx. 30 ng/dL and 300 ng/dL testosterone), spiked with potential interferents.
      • Heterophile Interference: 19 HAMA-positive serum samples.
      • Cross-Reactivity: Two sample pools (approx. 0 ng/dL and 300 ng/dL testosterone), spiked with potential cross-reactants.
      • Data Provenance: Not explicitly stated for all studies, but reference interval samples for pediatrics were "collected prospectively". It is generally inferred for in vitro diagnostic device submissions that data is from a clinical laboratory setting, likely in the US or regions where regulatory standards are aligned. No specific country of origin is mentioned for all samples.

    • ADVIA Centaur SHBG Assay:

      • Precision: 3 patient serum specimens, 2 patient pools, 3 control levels. Assayed once a day in replicates of 5 for 5 days (n = 25 replicates per sample).
      • Linearity: 11 serially diluted samples. Each sample tested in duplicate.
      • Dilution Recovery: 5 serum samples.
      • Method Comparison: 174 serum samples against Elecsys SHBG assay.
      • Data Provenance: Not explicitly stated.

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

    This information is not provided in the document. For in vitro diagnostic assays like these, the "ground truth" is typically established through a reference method (e.g., ID-LC-MS/MS for testosterone) or a well-established predicate device, rather than through expert consensus in the same way it might be for image analysis. The document details traceability to international standards (e.g., WHO 2nd International Standard for SHBG) and reference methods.

    4. Adjudication method for the test set:

    This information is not applicable as the context is an in vitro diagnostic assay evaluating quantitative measurements against reference methods or predicate devices, not subjective assessments requiring expert 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 in vitro diagnostic assay for quantitative determination of hormones, not an AI-powered diagnostic tool requiring human reader studies or MRMC studies.

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

    This is not applicable as the device is a laboratory assay system. Its performance characteristics (precision, linearity, accuracy, etc.) are inherently "standalone" in the sense that the system itself provides the quantitative result. There is no human-in-the-loop component in terms of result interpretation that would typically apply to AI/imaging diagnostics.

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

    • ADVIA Centaur Testosterone II (TSTII) Assay:

      • Traceability/Standardization: ID-LC-MS/MS (CDC HoSt Testosterone Reference Measurement Procedure), which is traceable to the primary testosterone standard National Measurement Institute (NMI) M914. This is a highly accurate chemical reference method.
      • Method Comparison: Comparison against the CDC HoSt ID-LC-MS/MS method (reference method) and another legally marketed predicate device (Dimension Vista Total Testosterone assay).
      • Reference Intervals: Established using samples from "apparently healthy" individuals, with methodologies aligned with CLSI guideline EP28-A3c.

    • ADVIA Centaur SHBG Assay:

      • Traceability/Standardization: Standardized to World Health Organization (WHO) 2nd International Standard for SHBG, NIBSC code 08/266.
      • Method Comparison: Comparison against a legally marketed predicate device (Elecsys SHBG assay).

    8. The sample size for the training set:

    This information is not provided in the document. For in vitro diagnostic assays like these, there isn't typically a "training set" in the machine learning sense. Instead, assay development involves extensive internal testing and optimization (sometimes referred to as development or verification lots) before the formal validation studies presented in this document. The sample sizes listed above are for the validation (test) phase.

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

    As mentioned in point 8, a "training set" in the machine learning context is not applicable here. The development and optimization of the assay would rely on established chemical and biological principles and internal reference materials, which would themselves be traced to primary standards or reference methods as described in point 7 for the "ground truth" of the final product.

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