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510(k) Data Aggregation

    K Number
    K181525
    Device Name
    INNOVANCE Free PS Ag
    Manufacturer
    Siemens Healthcare Diagnostics Products GmbH
    Date Cleared
    2018-09-07

    (88 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K010963
    Why did this record match?
    Device Name :

    INNOVANCE Free PS Ag

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

    For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex® CS-5100 analyzer.

    As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations.

    Device Description

    The INNOVANCE® Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components. One component (Reagent) contains polystyrene particles coated with two different monoclonal antibodies both specific for free protein S. This latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected turbidimetrically via the increase in turbidity.

    AI/ML Overview

    The provided document describes the Siemens Healthcare Diagnostics Products GmbH's INNOVANCE Free PS Ag device (K181525) and its performance data in support of its substantial equivalence to a predicate device.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a single table of "acceptance criteria" against which all performance metrics are directly compared. Instead, it discusses various studies with implicit acceptance criteria (e.g., successful verification of LoQ, fulfillment of predetermined criteria for Passing-Bablok regression). I'll compile a table based on what can be inferred for key performance characteristics.

    Performance MetricAcceptance Criteria (Inferred from study description)Reported Device Performance
    Measuring Interval (Limit of Quantitation - LoQ)Lower limit of 10% of norm must be accurately measurable with Total Error ≤ 4.0% of norm.Successfully verified. Study confirms lower limit of 10% of norm can be accurately measured.
    Measuring Interval (Linearity)Maximal deviation from theoretical ideal linearity: ± 3.2% of norm for
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