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510(k) Data Aggregation

    K Number
    K020610
    Device Name
    LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
    Manufacturer
    BIO-RAD
    Date Cleared
    2002-04-22

    (56 days)

    Product Code
    DIE,CFR
    Regulation Number
    862.3280
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K984477
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

    Device Description

    The Lyphochek® Whole Blood Metals Control is a lyophilized control prepared from human whole blood with pure chemicals and stabilizers added. The control is provided in lyophilized form for increased stability.

    AI/ML Overview

    Here's an analysis of the provided text regarding the Lyphochek® Whole Blood Metals Control, structured according to your request.

    1. Table of Acceptance Criteria and Reported Device Performance

    The FDA submission for the Lyphochek® Whole Blood Metals Control focuses on demonstrating substantial equivalence to a predicate device and establishing stability claims, rather than defining and directly reporting against specific numerical "acceptance criteria" in the way one might see for diagnostic accuracy. The key performance indicators are related to the stability of the control material.

    Acceptance Criteria (Implied)Reported Device Performance
    Opened Vial Stability (2-8°C)All analytes stable for 14 days, with the exception of red cell folate, which is stable for 1 day.
    Unopened Vial Shelf Life (2-8°C)Stable for 3 years and 3 months.
    Substantial Equivalence to Predicate Device (K984477)The new device shares the same intended use, lyophilized form, human whole blood matrix, and unopened storage conditions as the predicate. The differences (expanded analyte list, shorter red cell folate opened stability) do not raise new questions of safety or effectiveness.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: The document does not specify a distinct "test set" sample size in terms of number of patient samples or production lots. The stability studies likely involved multiple vials/lots of the control material. For the substantial equivalence argument, the comparison is qualitative between the new and predicate device specifications rather than a quantitative test of a specific dataset.
    • Data Provenance: The data comes from internal "stability studies" performed by Bio-Rad Laboratories. The information provided does not specify the country of origin for the data or whether it was retrospective or prospective. Given that it's a stability study for a new product, it would inherently be prospective in nature, testing the product over time.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This type of information is not applicable to this device. The Lyphochek® Whole Blood Metals Control is a quality control material, not a diagnostic device that requires expert interpretation of results to establish ground truth. Its performance is assessed through analytical stability testing using established laboratory methods for measuring the target analytes.

    4. Adjudication Method for the Test Set

    This is not applicable. There is no "adjudication method" in the context of stability testing for a quality control material. The performance is determined by instrument measurements against specified analytical criteria over time.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

    This is not applicable. This device is a quality control material, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant to its evaluation.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    This is not applicable. This device is a physical control material, not a software algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for the stability studies would be the expected analytical values for each analyte within the control material, determined by reference methods or manufacturing specifications. The stability is then assessed by measuring the analytes over time and comparing the results to these established reference values, ensuring they remain within acceptable limits. This is an analytical ground truth, not a clinical ground truth derived from pathology or patient outcomes.

    8. The Sample Size for the Training Set

    This is not applicable. This device is a quality control material and does not involve machine learning or a "training set" in the conventional sense.

    9. How the Ground Truth for the Training Set Was Established

    This is not applicable for the same reasons as point 8.

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