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510(k) Data Aggregation

    K Number
    K022690
    Device Name
    PAROS CRP
    Manufacturer
    HORIBA LTD.
    Date Cleared
    2002-12-23

    (132 days)

    Product Code
    DCN
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K002646,K981638
    Why did this record match?
    Reference Devices :

    K002646, K981638

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

    The indications for use of the Paros CRP are for aiding in diagnosis and monitoring of inflammatory diseases. The primary utility is for screening for the presence of inflammatory disease, by measuring CRP on anti-coagulated whole blood samples, and thus eliminating the requirement for sample centrifugation. CRP measurement on serum samples is also possible.
    A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein, aids in evaluation of the amount of inflammatory injury to body tissues.

    Device Description

    The Paros CRP is a benchtop C-Reactive Protein Immunological Test System. It is a single parameter instrument (CRP only), with the ability to measure CRP on Whole Blood and Serum samples in-vitro. It employs the same measurement principles as the CRP measurement module of the ABX / Horiba ™MICROS CRP (K002646, October 2000). The Paros CRP does not have a cell counting module.
    The CRP levels are measured in patients by reacting anti-CRP antibody coated latex particles with lyzed blood, and determining the rate of the turbidimetric reaction in the near infrared spectrum.

    AI/ML Overview

    Here's an analysis of the Paros CRP device's acceptance criteria and study, based on the provided text:

    Acceptance Criteria and Device Performance for Paros CRP

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are not explicitly stated as numerical targets in the provided document. Instead, the document describes performance metrics that demonstrate "good," "excellent," or "no significant" issues. Based on the "Discussion of Performance Data Summary" section, the following can be inferred and presented:

    Performance MetricAcceptance Criteria (Inferred from text)Reported Device Performance
    Precision"Good precision"Total Imprecision ranged from 0 to 2.6 CV%.
    Accuracy / Bias"No evidence of significant bias"No significant bias reported (assessed by NCCLS EP 9-A).
    Correlation (Whole Blood)"Good correlation" with predicate device (Beckman Immage)R²=0.99 (between Paros CRP and Beckman Immage).
    Correlation (Serum)"Excellent correlation" with predicate device (Beckman Immage)R²=0.98 (between Paros CRP and Beckman Immage).
    Linearity (Whole Blood)Supports linearity claim from 0.2 to 10 mg/dLDemonstrated linearity across tested range (Paros CRP result = 1.05 X Expected Target CRP value, R²=0.99) for 0.2 to 10 mg/dL.
    Linearity (Serum)Supports linearity claim from 0.2 to 7 mg/dLDemonstrated linearity across tested range (Paros CRP result = 0.9 X Expected Target CRP value, R²=0.98) for 0.2 to 7 mg/dL.
    Sample StabilityReproducibility of results over 72 hours, with acceptable deviationReproducibility over 72 hours. At 0.2 mg/dL, % difference attributed to single decimal point and CRP level. All other results
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