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    K Number
    K101809
    Device Name
    FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
    Manufacturer
    FUJIREBIO DIAGNOSTICS, INC
    Date Cleared
    2010-10-05

    (98 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K082036,K093957
    Why did this record match?
    Device Name :

    FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20

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

    For In Vitro Diagnostic Use Only.

    Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.

    Device Description

    This quality control product can be used as an objective judgment of the laboratory's procedures and personnel techniques. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing systems within the clinical range.

    AI/ML Overview

    This document describes the Fujirebio Diagnostics Tumor Marker Control, a quality control product intended to monitor the precision of laboratory testing procedures for various tumor markers. It is a Class I, reserved medical device.

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly state "acceptance criteria" in a quantitative sense for the device's performance as a control material. Instead, its performance is measured by its equivalence to a predicate device in terms of intended use, analytes, matrix, form, and stability. The performance is reported by comparing its features and characteristics to those of the predicate devices.

    Feature / CriterionFujirebio Diagnostics Tumor Marker Control (Proposed Device)Bio-Rad Lyphochek® Tumor Marker Plus Control (Predicate) / ARCHITECT HE4 Control Kit (Predicate for HE4)
    Device TypeIn vitro diagnosticIn vitro diagnostic
    ClassificationClass I, reservedClass I, reserved
    CFR section862.1660862.1660
    Product CodeJJYJJY
    Product UsageClinical and Hospital laboratoriesClinical and Hospital laboratories
    Intended UseAssayed control serum to monitor the precision of laboratory testing procedures for AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.Assayed quality control serum to monitor precision for analytes listed in package insert (Lyphochek). Verification of accuracy and precision for ARCHITECT i System (HE4).
    MatrixHuman SerumHuman Serum (Lyphochek); Protein buffer (ARCHITECT HE4)
    FormLyophilizedLyophilized (Lyphochek); Liquid (ARCHITECT HE4)
    AnalytesAFP, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, HE4, PSA, Free PSAAFP, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, PSA, Free PSA (Lyphochek); HE4 (ARCHITECT HE4)
    Stability - Reconstituted at 2-8°C14 days at 2-8°C, except Free PSA (7 days)14 days at 2-8°C, except Free PSA (7 days)
    Number of Levels23
    PSA Stability (reconstituted)Total PSA - 14 days, Free PSA - 7 daysTotal PSA – 7 days, Free PSA - 7 days
    Reconstitution Volume3.0 mLs2.0 mLs
    Additional AnalytesHE4 (Human Epididymis Protein 4)ACTH, Aldosterone, Beta-2-Microglobulin, CA 27.29, Calcitonin, hCG, Prolactin, Prostatic Acid Phosphatase, and Thyroglobulin (Lyphochek)
    Stability (unopened)18 months at 2-8°C3 years at 2-8°C (Lyphochek); 9 Months (ARCHITECT HE4)
    Stability - Reconstituted at 2-8°CCEA and Total PSA 14 days at 2-8°CCEA 11 days at 2-8°C, Total PSA 7 days at 2-8°C
    **Stability - Reconstituted at
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