LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982471

    Validate with FDA (Live)

    Device Name
    B2-MICROGLOBULIN CONTROL SET SERUM
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1998-08-06

    (21 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    All
    Reference & Predicate Devices
    K890421
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ß2-microglobulin Control Set Serum is used for the quality control of the Boehringer Mannheim Tinaquant ß2-microglobulin assay.

    The ß2-microglobulin Control Set Serum is used for monitoring accuracy and precision of the Boehringer Mannheim Tinaquant ß2-microglobulin assay.

    Device Description

    The Boehringer Mannheim ß2-microglobulin Control Set Serum is manufactured using human serum albumin, ß2-microglobulin, and stabilizers. The analyte is appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called "β2-microglobulin Control Set Serum." This document is primarily focused on establishing substantial equivalence of a new control set to an existing one for quality control in laboratory assays. It does not contain information about acceptance criteria for a device's performance in a clinical study, nor does it describe a study that proves the device meets such criteria.

    Specifically, the document focuses on:

    • Device identification: Naming the device and its intended use (quality control of a specific assay).
    • Predicate device comparison: Comparing the new control set to an existing one (Abbott Imx β2-microglobulin assay controls) to demonstrate substantial equivalence based on similarities (intended use, same analyte) and minor differences (control levels, matrix, preparation).
    • Regulatory information: Such as the submitter's name, contact, date prepared, and the FDA's clearance letter.

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC study, or standalone algorithm performance) from the provided text. The document describes a control product used for quality assurance, not a diagnostic or therapeutic device whose performance would be assessed against clinical acceptance criteria in the manner you've outlined.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1