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510(k) Data Aggregation

    K Number
    K955812
    Device Name
    SYSCON TURMOR MARKER CONTROL
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    1996-03-12

    (77 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    K990531
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use as an assayed quality control material to assist in monitoring accuracy and precision in clinical immunoassays used in cancer antigen testing.

    Device Description

    This is a two level, multi-analyte, lyophilized quality control material prepared from human blood, with added purified chemicals, human biochemicals and preservatives.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called "SysCon (or other brand names) Tumor Marker Control." This document focuses on the regulatory submission for a quality control material and does not describe a study involving patient data, AI, or diagnostic algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truthing for such a device is not present in the provided text.

    Based on the information given, here's what can be extracted and what cannot:

    1. A table of acceptance criteria and the reported device performance

    The document mentions "Performance data" related to the quality control material itself, not a diagnostic device's ability to interpret patient data.

    Acceptance Criteria Category (Implied)Reported Device Performance (Summary Statement)
    Comparison to predicate device"Comparison of the product to the predicate device for intended use, analytes, number of levels, form, diluent, base, additives, microbial content, lot homogeneity and vial-to-vial consistency, stability and reliability of assay values supports a substantial equivalence finding."
    Nonclinical tests"Nonclinical tests for vial-to-vial variability, reconstituted stability and expiration dating, as well as value assignment protocols, submitted, referenced, or relied on in the premarket notification submission, support the conclusion that the device is as safe and effective, and performs as well as or better than the legally marketed devices identified in this summary."

    *Note: Specific numerical acceptance criteria (e.g., CV

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