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510(k) Data Aggregation

    K Number
    K190702
    Device Name
    Lumipulse G whole PTH
    Manufacturer
    Fujirebio Diagnostics, Inc.
    Date Cleared
    2019-08-30

    (165 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K150879
    Why did this record match?
    Device Name :

    Lumipulse G whole PTH

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

    For in vitro diagnostic use.
    Lumipulse G whole PTH is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

    Device Description

    The Lumipulse G whole PTH Immunoreaction Cartridges consists of 3 × 14 tests. Each kit contains the following:

    1. Antibody-Coated Particle Solution (Liquid when used, 200 µL/Immunoreaction Cartridge) Contains 200 µg/mL anti-PTH polyclonal antibodies (goated ferrite particles, protein stabilizers (bovine and goat) and chemical stabilizers in MES buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: ProClin 300
    2. Enzyme-Labeled Antibody Solution (Liquid, 120 µL/Immunoreaction Cartridge) Contains 0.2 µq/mL alkaline phosphatase (ALP: calf)-labeled anti-PTH polyclonal antibody (qoat), protein stabilizers (bovine) and chemical stabilizers in MES buffer. Preservative: ProClin 300
    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Lumipulse G whole PTH device, based on the provided FDA 510(k) summary:

    Device: Lumipulse G whole PTH (Fujirebio Diagnostics, Inc.)
    Intended Use: Quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System for differential diagnosis of hypercalcemia and hypocalcemia.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document describes various analytical performance characteristics. For each characteristic, the reported performance is presented. Acceptance criteria are generally implied by the positive outcomes of the studies and their adherence to CLSI guidelines. For example, for precision, a certain percentage of Coefficient of Variation (%CV) is considered acceptable.

    Acceptance Criteria CategorySpecific Metric / StudyReported Device Performance (Lumipulse G whole PTH)
    Analytical Precision20-Day Precision (Total %CV)≤ 4% (e.g., Control Level 1: 3%, Serum 7: 3%)
    Lot-to-Lot Precision (Inter-lot %CV)≤ 4% (e.g., Control Level 1: 4%, Serum 4: 3%)
    Site-to-Site Precision (Total %CV)≤ 6.7% (e.g., Serum 1: 6.3%, Serum 2: 6.7%)
    Linearity/Reportable RangeLinearity Range (Correlation R²)1.4 pg/mL - 2190.3 pg/mL (R²=0.9984)
    Measuring Range4.0 pg/mL - 1800.0 pg/mL
    Detection LimitsLimit of Blank (LoB)0.0 pg/mL
    Limit of Detection (LoD)0.295 pg/mL
    Limit of Quantitation (LoQ)2.128 pg/mL (defined as interassay CV of 10%)
    Analytical Specificity/Cross-ReactivityCross-Reactivity with specified substances (e.g., Calcitonin, PTH fragments)
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