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510(k) Data Aggregation

    K Number
    K240987
    Device Name
    Access sTfR
    Manufacturer
    Beckman Coulter Inc.
    Date Cleared
    2024-07-03

    (84 days)

    Product Code
    DDG
    Regulation Number
    866.5880
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    k080634,K080634
    Why did this record match?
    Reference Devices :

    K080634

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

    The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).

    This assay may also be used in conunction with an Access Ferritin measurement to provide a calculated sTR log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.

    Device Description

    Access sTfR: The sTfR assay reagent pack consists of two specific reagents: (R1a) paramagnetic particles coated with streptavidin:biotinylated soluble transferrin receptor monoclonal antibody, proteins (mouse, goat, bovine), bovine serum albumin (BSA), 0.1% sodium azide, and 0.17% ProClin 300; and (R1b) Monoclonal mouse anti-human soluble transferrin receptor alkaline phosphatase (bovine) conjugate, BSA, 0.1% sodium azide and 0.17% ProClin 300. Two assay packs containing 50 tests per pack are provided for a total of 100 assay determinations.

    The Access sTfR assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with paramagnetic particles coated with anti-sTfR antibody. During incubation, the sTfR antigen in the sample binds to the immobilized anti-sTfR antibody on the solid phase. Alkaline phosphatase conjugated anti-sTfR antibody is then added and reacts with a different antigenic site on the sTfR molecule.

    After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Access sTfR device, based on the provided FDA 510(k) summary:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device PerformanceMeets Criteria?
    Method ComparisonSlope: 0.99 – 1.01 (95% CI)Slope: 1.00 (95% CI: 0.99 – 1.01)Yes
    Intercept: -0.14 - 0.15 (95% CI)Intercept: -0.016 (95% CI: -0.14 - 0.15)Yes
    Correlation Coefficient (R): Not explicitly stated as acceptance, but comparison shows R = 1.00Correlation Coefficient (R): 1.00Yes (Excellent)
    Imprecision≤ 0.72 nmol/L SD at concentrations ≤ 9 nmol/LSample 1 (9.1 nmol/L): 0.24 nmol/L SDYes
    ≤ 8.0% CV at concentrations > 9 nmol/LSample 2 (17 nmol/L): 2.6% CV
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