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    K Number
    K161158
    Device Name
    IDS-iSYS Intact PTHN
    Manufacturer
    IMMUNODIAGNOSTIC SYSTEMS LTD
    Date Cleared
    2017-01-31

    (281 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K091849,K103325
    Why did this record match?
    Device Name :

    IDS-iSYS Intact PTHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IDS-iSYS Intact PTH+ assay is an in vitro diagnostic device intended for the quantitative determination of intact PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated System. Results are to be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

    Device Description

    The IDS-iSYS Intact PTH" assay is based on chemiluminescence technology. 100 uL of patient sample is incubated with a biotinylated polyclonal anti-PTH (39-84) antibody and an acridinium labelled PTH (13-34) antibody. Streptavidin labelled magnetic particles are added prior to a second incubation step. The magnetic particles are captured using a magnet and a wash step performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of Intact PTH in the original sample.

    IDS-iSYS Intact PTH reagent kit consists of one (1) Immunoassay Cartridge, two (2) vials each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.

    IDS-iSYS Intact PTHN Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. The IDS-iSYS Intact PTHN Cartridge contains the following ready to use reagents:

    • · Magnetic particles coated with streptavidin in a phosphate buffer containing sodium azide as preservative (1% (w/w%).
    • · Calibrator B: Two vials of lyophilized porcine serum matrix buffer containing high level PTH and sodium azide as preservative >1% (w/w%).

    The submission is due to a new source of antibody for the assay.

    AI/ML Overview

    This document describes the performance characteristics of the IDS-iSYS Intact PTHN assay, an in vitro diagnostic device for quantitative determination of intact PTH.

    Here's an analysis of the acceptance criteria and study information provided:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are not explicitly stated as distinct numerical targets but are implicitly defined by the reported performance and the comparison to the predicate device. The information below summarizes the performance characteristics provided, which in a regulatory context, demonstrate the device meets its intended use and is substantially equivalent to the predicate.

    Performance CharacteristicPredicate Device (K103325) PerformanceCandidate Device (IDS-iSYS Intact PTHN) PerformanceImplied Acceptance Criteria (Demonstrated)
    Method Comparison (against a commercially available method)N/An=312 samples; Slope: 1.02 (95% CI: 0.99 to 1.04); Intercept: -0.7 pg/mL (95% CI: -5.4 to 4.1); Correlation coefficient (r): 1.00Demonstrate strong correlation and agreement with a commercially available quantitative chemiluminescence Intact PTH assay (e.g., r close to 1, slope close to 1, intercept close to 0) as per CLSI EP-9A2 guidelines.
    Sample Matrix Comparison (vs. K2 EDTA plasma)N/A
    - Serum (Red Top)N/An=52; Slope: 0.94 (95% CI: 0.92 to 0.97); Intercept: 2.55 (95% CI: 0.86 to 3.16); r: 1.00Demonstrate acceptable agreement across different sample matrices (serum, lithium heparin plasma) compared to the control (K2 EDTA plasma) as per CLSI EP9-A3 guidelines. Slopes close to 1 and intercepts close to 0 with good correlation coefficients.
    - Serum (SST)N/An=52; Slope: 0.93 (95% CI: 0.91 to 0.96); Intercept: 2.38 (95% CI: 1.25 to 3.15); r: 1.00
    - Lithium HeparinN/An=52; Slope: 0.98 (95% CI: 0.95 to 0.99); Intercept: 0.42 (95% CI: -0.43 to 1.63); r: 1.00
    Reference Interval11.5 to 78.4 pg/mL10.3 to 80.5 pg/mLEstablish a 95% reference interval for a healthy population, consistent with clinical expectations and CLSI C28-A3 guidelines. The new range should be comparable to the predicate.
    Sensitivity
    - Limit of Blank (LoB)1.2 pg/mL0.9 pg/mLDemonstrate low limits of blank, detection, and quantitation, indicating the ability to detect very low concentrations of PTH, as per CLSI EP17-A guidelines. Should be comparable or better than the predicate.
    - Limit of Detection (LoD)2.5 pg/mL2.3 pg/mL
    - Limit of Quantitation (LoQ)4.5 pg/mL4.5 pg/mL
    Precision
    - Within-run CV%1.1% to 6.3%1.5% to 9.9%Demonstrate consistent and reproducible results across different concentration levels, within acceptable ranges for clinical diagnostic assays, as per CLSI EP-5A2 guidelines. Total CV should be within acceptable limits (e.g.,
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