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    K Number
    K040030
    Device Name
    BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    2004-06-16

    (161 days)

    Product Code
    DCN
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Immunology (IM)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114

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

    The BioCheck CRP Rapid Test is intended for the qualitative detection of C-reactive protein (CRP) in human serum. Measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

    Device Description

    The BioCheck CRP Rapid Test is a colloidal gold/antibody conjugate-based immunoassay designed for the detection of CRP in human serum samples. To perform the serum CRP test, serum is added to the Sample Well. CRP in the specimen is bound by a gold-antibody conjugate forming a gold-antigen complex. This complex migrates across the membrane by capillary action and reacts with a goat anti-human CRP polyclonal antibody immobilized in the test region to produce a pink color band when the CRP concentration is equal to or greater than 4.0 mg/L. If the CRP concentration is less than 4.0 mg/L, there is no line in the test line area. The gold-conjugate continues to migrate to the control line area and produce a pink color band, indicating a valid test.

    AI/ML Overview

    BioCheck CRP Rapid Test Study Analysis

    Here's a breakdown of the acceptance criteria and the study proving the BioCheck CRP Rapid Test meets them, based on the provided document:

    1. Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance Criteria (Inferred)Reported Device Performance
    Precision100% agreement between multiple testing sites for various CRP concentrations.Four laboratories tested blinded serum samples spiked with purified CRP at 5 concentrations (1.0, 2.0, 5.0, 4.0 mg/L - note: the document lists 4.0 thrice and 1.0 five times, which seems like a typo, assuming 5 distinct concentrations were intended for the 5-sample set). Five replicates of each sample were tested. The results demonstrated 100% agreement between sites.
    InterferenceNo interference from specified endogenous substances and common-used drugs at predefined levels.The following potentially interfering substances showed no interference: Biotin (200 ng/mL), Bilirubin (10 mg/dL), Hemoglobin (200 mg/dL), Cholesterol (800 mg/dL), Triglyceride (1250 mg/dL). In addition, no interference was observed from a long list of common-used drugs (~10 µg/ml final concentration) within their normal therapeutic ranges.
    Hook EffectNo hook effect up to a specified high CRP concentration.When a CRP standard of 200 mg/L was used, the test line appeared within 5 minutes, indicating no hook effect if the CRP concentration in the patient serum sample is equal to or below 200 mg/L.
    Recovery100% agreement between expected and observed results for fortified samples at various CRP concentrations.Normal human serum was supplemented with purified human CRP at 5 concentrations (numbers not specified, but implied to be distinct from the precision study). These samples were tested in six replicates. The data showed 100% agreement between the expected and the observed results at each CRP concentration.
    Clinical ComparisonHigh positive, negative, and overall agreement with a commercially available quantitative predicate assay (BioCheck hsCRP ELISA) at a 4.0 mg/L cutoff.The BioCheck CRP Rapid Test was compared to the BioCheck hsCRP ELISA.
    Overall Positive Agreement (>= 4 mg/L) = 98.2%
    **Overall Negative Agreement (
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