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510(k) Data Aggregation

    K Number
    K033471
    Device Name
    PHOSPHOLIN ES AND CALCIUM CHLORIDE
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2004-02-04

    (93 days)

    Product Code
    GGW
    Regulation Number
    864.7925
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K863594
    Why did this record match?
    Device Name :

    PHOSPHOLIN ES AND CALCIUM CHLORIDE

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

    The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.

    Device Description

    R2 Diagnostics Phospholin ES is a liquid reagent containing ellagic acid as the activator and phospholipids derived from soybean lecithin. The reagent also contains buffer and preservatives. Phospholin ES is an in vitro diagnostic reagent intended for use for the performance of the activated partial thromboplastin time two-stage test (APTT) and related coagulation factor assays. Phospholin ES is sensitive to lupus anticoagulants. Phospholin ES as with any APTT test requires the addition on 0.02-0.025M Calcium Chloride to perform the assay.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the R2 Diagnostics Phospholin ES device, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document frames its "acceptance criteria" and "device performance" in terms of substantial equivalence to a predicate device. The performance criteria are primarily correlation coefficients and precision for various sample types.

    Acceptance Criterion (Type)Predicate Device PerformanceProposed Device Performance (Reported)
    Correlation: Normal & Abnormal Patients (Photo-optical)N/A (implied by predicate's established performance)R = 0.92, Slope = 0.864
    Correlation: Normal & Abnormal Patients (Mechanical)N/AR = 0.93, Slope = 1.09
    Correlation: Lupus Anticoagulant Samples (Photo-optical)N/AR = 0.94, Slope = 0.866
    Correlation: Lupus Anticoagulant Samples (Mechanical)N/AR = 0.99, Slope = 0.627
    Precision: Within-run CV
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