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510(k) Data Aggregation

    K Number
    K072638
    Device Name
    ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2007-10-19

    (31 days)

    Product Code
    JGQ
    Regulation Number
    862.1635
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K913615
    Why did this record match?
    Device Name :

    ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801

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

    In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.

    Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney or bone marrow as well as metabolic or nutritional disorders.

    Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders, which are characterized by proteinuria or albuminuria.

    CSF protein measurements are used in diagnosis and treatment of conditions such as meningitis, brain tumors and infections of the central nervous systems.

    Device Description

    The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.

    The modified device includes both the original endpoint assay and the additional rate assay. The new rate assay was developed to provide absorbance limits that will flag high protein samples with high absorbance, thus eliminating the need for prescreening samples for high protein levels. The endpoint assay still requires sample prescreening or inspection of the Reaction Monitor display after completion of the reaction to ensure that high samples are detected and appropriately diluted for rerun. The attached labeling provides a more complete description of this potential high sample / prozone effect.

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary regarding the Roche/Hitachi Urinary/CSF Protein test, focusing on acceptance criteria and supporting study details:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document is a 510(k) Special Modification submission, which focuses on comparing a modified device (with an added "rate" application) to a predicate device (the original "endpoint" application). Therefore, the "acceptance criteria" discussed are largely implicit in demonstrating substantial equivalence to the predicate, with performance characteristics being compared directly.

    Feature / CriteriaPredicate Device Performance (Endpoint Assay, K913615)Modified Device Performance (Rate Application)Acceptance Criteria (Implicit)
    Intended UseFor the quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF).In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.Maintain intended use of predicate.
    SpecimenUrine and CSFSameSame specimen types as predicate.
    ApplicationEndpoint assayEndpoint and Rate applicationNew rate application should be equivalent to or improve upon endpoint.
    Measuring Range (Urine)2-200 mg/dL6-200 mg/dL (Rate Assay)Equivalent or improved measuring range.
    Measuring Range (CSF)2-200 mg/dL6-200 mg/dL (Rate Assay)Equivalent or improved measuring range.
    Lower Detection Limit (Urine)2 mg/dL6 mg/dL (Rate Assay)Acceptable detection limit for clinical use, comparable to predicate.
    Lower Detection Limit (CSF)2 mg/dL6 mg/dL (Rate Assay)Acceptable detection limit for clinical use, comparable to predicate.
    Expected ValuesUrine Random:
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