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510(k) Data Aggregation

    K Number
    K042389
    Device Name
    MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2004-09-14

    (12 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K993360
    Why did this record match?
    Device Name :

    MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA

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

    Precinorm ® U Plus is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath ® U Plus is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

    Device Description

    Precinorm ® U Plus/ Precipath ®U Plus is a quality control product consisting of lyophilized human sera with constituents added as required to obtain desired component levels. Concentrations of control components have been adjusted to represent normal and pathological ranges.

    AI/ML Overview

    The provided text is a 510(k) summary for the Precinorm® Universal Plus and Precipath® Universal Plus Control Sera. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a predicate device already on the market. It describes the device, its intended use, and compares it to the predicate device.

    However, the document DOES NOT contain information about acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The document states that the new device is substantially equivalent to the currently marketed Roche Diagnostics Precinorm® U Plus/ Precipath® U Plus (K993360). The focus is on demonstrating that changes to certain characteristics (like stability and the origin of some biological additives) do not alter the substantial equivalence to the previously cleared predicate device.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study to prove they are met because the provided text does not contain this information. The document is a 510(k) summary focused on demonstrating substantial equivalence, not on presenting a study to meet specific performance acceptance criteria for a novel device.

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