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510(k) Data Aggregation

    K Number
    K121907
    Device Name
    DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Date Cleared
    2012-07-23

    (24 days)

    Product Code
    CJO,JIT
    Regulation Number
    862.1050
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k991576,k061818
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ALPI method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma on the Dimension® clinical chemistry system. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

    ALPI CAL is an in vitro diagnostic product for the calibration of alkaline phosphatase (ALPI) method on the Dimension® clinical chemistry system.

    Device Description

    The ALPI method employs alkaline phosphatase that catalyzes the transphosphorylation of pnitropheny | phosphate (p-NPP) to p-nitrophenol (p-NP) in the presence of the transphosphorylating buffer, 2 amino-2-methyl-1-propanol (AMP). The reaction is enhanced through the use of magnesium and zinc ions. The change in absorbance at 405 nm due to the formation of p-NP is directly proportional to the ALP activity, since other reactants are present in non-rate limiting quantities and is measured using a bichromatic (405, 510 nm) rate technique.

    The ALPI CAL is a three (3) level, liquid calibrator. It is packaged as a kit of six vials, two vials per level (1, 2 and 3) with 1.0 mL per vial. The product matrix is a human serum albumin based product containing alkaline phosphatase from porcine kidney. Levels 2 and 3 contain alkaline phosphatase at the following concentrations.

    Level 1: 0 U/L
    Level 2: 500 U/L
    Level 3: 1000 U/L

    This product is sold separately from the Flex® reagent cartridge. Values are assigned to new lots from a Masterpool that is from an International Federation of Clinical Chemistry (IFCC) reference.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Device Performance

    Criteria (Test)Acceptance Criteria (Implied)Reported Device Performance
    Method ComparisonStrong correlation (r ≈ 1) and minimal bias compared to predicate device.ALPI vs. ADVIA® ALPAMP: Slope: 1.06; Intercept: -0.4 U/L; Correlation Coefficient (r): 0.999.
    Serum/Plasma ComparisonStrong correlation (r ≈ 1) and minimal bias between serum and plasma samples.Serum vs. Lithium Heparin Plasma: Slope: 1.02; Intercept: -5.08 U/L; Correlation Coefficient (r): 0.999.
    Reference IntervalEstablished expected range for healthy adults.Expected Values: 46-116 U/L [0.77 - 1.94 µkat/L] (representing the central 95% of results).
    Precision (Repeatability & Within-Lab)Low coefficient of variation (CV%) for various control levels and serum pools.Repeatability:- BioRad QC Level 1: Mean 37 U/L, SD 0.6 U/L, %CV 1.5- BioRad QC Level 2: Mean 157 U/L, SD 1.0 U/L, %CV 0.6- BioRad QC Level 3: Mean 303 U/L, SD 3.3 U/L, %CV 1.1- Serum Pool 1: Mean 81 U/L, SD 1.1 U/L, %CV 1.4- Serum Pool 2: Mean 842 U/L, SD 5.7 U/L, %CV 0.7Within-Lab:- BioRad QC Level 1: SD 1.6 U/L, %CV 4.2- BioRad QC Level 2: SD 3.7 U/L, %CV 2.3- BioRad QC Level 3: SD 7.1 U/L, %CV 2.4- Serum Pool 1: SD 1.8 U/L, %CV 2.2- Serum Pool 2: SD 13.3 U/L, %CV 1.6
    LinearityAnalytical measurement range demonstrates linear response.Analytical measurement range: 10 - 1000 U/L. Scatter plot showed y = 0.9868x + 9.7726 with R-squared = 0.9992.
    Analytical Specificity/InterferencesBias due to common interferents (hemoglobin, bilirubin, lipemia) < 10%.- Hemoglobin (1000 mg/dL): <10% bias at 297 U/L and 823 U/L.- Bilirubin (unconjugated 80 mg/dL): <10% bias at 300 U/L and 834 U/L.- Bilirubin (conjugated 80 mg/dL): <10% bias at 307 U/L and 856 U/L.- Lipemia (Intralipid® 500 mg/dL): <10% bias at 308 U/L and 878 U/L.- Lipemia (Intralipid® 600 mg/dL): Tripped an error flag; interference could not be determined. Exogenous substances showed <10% bias at 299 U/L and 842 U/L.
    Limit of Blank (LoB)Established lowest analyte concentration with no false positives.LoB: 3 U/L.
    Limit of Detection (LoD)Established lowest analyte concentration reliably detected.LoD: 8 U/L.
    Limit of Quantitation (LoQ)Established lowest analyte concentration accurately quantified.LoQ: 9 U/L.

    Study Details

    This document describes performance characteristics typically reported for an in vitro diagnostic device, primarily focused on analytical performance and comparison to a predicate device. It does not appear to involve a study of an AI/ML algorithm or human-in-the-loop performance.

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

      • Method Comparison: 116 patient samples. Data provenance not explicitly stated (e.g., country of origin, retrospective/prospective), but implied to be human patient samples.
      • Serum/Plasma Comparison: 50 matched serum and lithium heparin plasma samples. Data provenance not explicitly stated.
      • Reference Interval: 132 healthy adults. Data provenance not explicitly stated.
      • Precision: Not based on patient samples directly; used three levels of Bio-Rad® Multiqual Assayed Quality Controls and two serum pools.
      • Linearity: n=9 samples (based on the figure description). Data provenance not explicitly stated.
      • Analytical Specificity/Interferences: Multiple samples tested with specific interferent concentrations (e.g., 2 samples for hemoglobin interference testing, 2 samples for bilirubin).
      • Limit of Blank, Limit of Detection, Limit of Quantitation: 5 samples for LoB, 5 low-level samples for LoD, 3 low-level samples diluted for LoQ.

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

      • This is not applicable to the device described. The studies measure the device's analytical performance against established laboratory standards and reference methods (e.g., predicate device, CLSI guidelines), not against expert determination of a medical condition. For example, "ground truth" for Alkaline Phosphatase levels comes from the actual concentration measured by a reference method or predetermined controls, not from expert consensus.

    3. Adjudication method for the test set:

      • This is not applicable as the studies focus on analytical performance and quantitative measurements, not on qualitative interpretations requiring adjudication.

    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, an MRMC comparative effectiveness study was not done. This device is a chemistry analyzer reagent and calibrator kit, not an AI/ML-driven diagnostic tool that would typically involve human readers.

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

      • The studies described are for the standalone analytical performance of the in vitro diagnostic device (reagent and calibrator) on a clinical chemistry system. This device is not an algorithm in the sense of AI/ML, but rather a chemical assay. Its performance is evaluated independently of human interpretation of the result it produces, though a human still interprets the clinical significance of that result.

    6. The type of ground truth used:

      • Method Comparison: The predicate device (ADVIA® Chemistry Alkaline Phosphatase AMP assay) served as the comparative "truth" for evaluating the new device's accuracy.
      • Serum/Plasma Comparison: Matched serum and lithium heparin plasma samples were used, where the goal was to show equivalence between the two sample types, implying their respective results represent the "truth" for that sample.
      • Reference Interval: Results from 132 healthy adults defined the expected range, serving as an epidemiological ground truth for a heathy population.
      • Precision: Bio-Rad® Multiqual Assayed Quality Controls and serum pools with known target values served as the ground truth.
      • Linearity: Expected ALP values derived from dilution series served as the ground truth.
      • Analytical Specificity/Interferences: Control samples (without interferent) and test samples (with known interferent concentrations) were used, with the control samples representing the baseline truth.
      • Limit of Blank, Limit of Detection, Limit of Quantitation: Enzyme Diluent (zero level) and specifically prepared low-level samples were used, with the known concentrations serving as the ground truth.
      • Overall, the ground truth relies on established reference methods, validated controls, known concentrations, and epidemiological data from healthy populations.

    7. The sample size for the training set:

      • This concept of a "training set" is not applicable. This is a traditional in vitro diagnostic device, not an AI/ML system that requires a training set for model development. The development of the reagents and assay method would involve R&D and optimization, but not in the same sense as training an algorithm on a dataset.

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

      • Not applicable, as there is no "training set" in the AI/ML context for this device.
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