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510(k) Data Aggregation

    K Number
    K133491
    Device Name
    ADVIA CENTAUR TESTOSTERONE (TSTO)
    Manufacturer
    Siemens Healthcare Diagnostics Inc.
    Date Cleared
    2014-02-21

    (100 days)

    Product Code
    CDZ
    Regulation Number
    862.1680
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K934562,k934562
    Why did this record match?
    Reference Devices :

    K934562

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

    For in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP systems.

    Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

    Device Description

    The ADVIA Centaur TSTO assay consists of the following:
    ADVIA Centaur TSTO Primary Reagent ReadyPack
    ADVIA Centaur TSTO Lite Reagent: acridinium ester-labeled testosterone in buffered saline with preservatives
    ADVIA Centaur TSTO Solid Phase: polyclonal rabbit antitestosterone antibody bound to monoclonal mouse antirabbit antibody covalently coupled to paramagnetic particles in buffered saline with sodium azide (0.1%) and preservatives
    Probe Wash: buffered saline with sodium azide (0.1%) and preservatives
    ADVIA Centaur TSTO Ancillary Reagent ReadyPack
    ADVIA Centaur TSTO Releasing Agent: steroid releasing agent (~0.1 µg/mL) in buffered saline with sodium azide (0.1%) and preservatives
    Cal E Low and High Calibrators: (After reconstitution) low or high levels of cortisol, progesterone and testosterone in human plasma with sodium azide (0.1%) and preservatives

    The methodology is Competitive immunoassay using direct chemiluminescent technology.

    AI/ML Overview

    The Siemens Healthcare Diagnostics Inc. ADVIA Centaur TSTO assay is a device for the quantitative determination of total testosterone in serum. The submission (K133491) is for a modification to the assay due to the qualification of a new polyclonal rabbit anti-testosterone pool. This is a Class I (Reserved) device, product code CDZ, and is regulated under 21 CFR 862.1680.

    Here's an analysis of the acceptance criteria and study in relation to the modified device:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document describes specific performance characteristics rather than explicit "acceptance criteria" with numerical thresholds for each test. However, we can infer the acceptance for some based on the reported results and the comparison to an existing predicate device. The primary acceptance for this submission is demonstrating "substantial equivalence" to the predicate device.

    Performance CharacteristicImplicit Acceptance Criteria (Inferred)Reported Device PerformanceComments
    PrecisionCVs within acceptable ranges for clinical assays.Patient Pool CVs: 7.1% - 13.3%
    Control Level CVs: 6.8% - 8.3%
    Serum Control CV: 9.1%Considered acceptable for diagnostic assays.
    LinearityMean recovery between 90-110%; Bias from linear fit estimate
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