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510(k) Data Aggregation

    K Number
    K090940
    Device Name
    SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
    Manufacturer
    ASTORIA-PACIFIC,INC.
    Date Cleared
    2009-12-14

    (255 days)

    Product Code
    JJT
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K990827
    Why did this record match?
    Reference Devices :

    K990827

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

    SPOTCHECK Blood Spot Controls are used for monitoring assay performance during in vitro diagnostic newborn screening for deficient Galactose-1-phosphate UridyItransferase (GALT) and/or Biotinidase enzyme activity. Enzyme response quantitation is provided in the product insert.

    Device Description

    SPOTCHECK Blood Spot Controls. Part No. 80-0900P4K, Blood Spot Controls, Deficient; 4 cards. Part No. 80-0901P4K, Blood Spot Controls, Normal; 4 cards. The controls are prepared with mixtures of human serum and human red blood cells. adjusted to approximately 55% hematocrit. Enzyme activity in the Deficient Control is decreased by heating. Enzyme activity in the Normal Control is supported by the addition of dithioerythritol (DTE). The mixtures are spotted on Whatman 903A filter paper and allowed to air dry at room temperature. The suppliers of serum and red blood cells certify that the materials have been tested using FDA-approved assays and shown to be negative for infectious disease agents. The SPOTCHECK Blood Spot Controls provide an ongoing indication of the assay performance. The Deficient Control responds below the assay cutoff, and the Normal Control responds above the assay cutoff within normal limits.

    AI/ML Overview

    The provided 510(k) summary (K090940) describes a medical device, the SPOTCHECK® Blood Spot Controls, which are quality control materials for newborn screening assays. The acceptance criteria and the study proving the device meets these criteria are detailed below.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Normal Control: Contains sufficient enzyme activity to be labeled as "normal."Each manufactured lot of Normal Control is tested using FDA-cleared SPOTCHECK Biotinidase and Uridyl Transferase 50-Hour Reagent Kits. The Normal Control responds above the assay cutoff, within normal limits, as verified in Astoria-Pacific's laboratory.
    Deficient Control: Has clinically deficient enzyme activity.Each manufactured lot of Deficient Control is tested using FDA-cleared SPOTCHECK Biotinidase and Uridyl Transferase 50-Hour Reagent Kits. The Deficient Control responds below the assay cutoff, as verified in Astoria-Pacific's laboratory.
    Stability: Stable for a minimum of 2 years from the manufacture date when stored at
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