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    K Number
    K091235
    Device Name
    RAMP RSV ASSAY
    Manufacturer
    RESPONSE BIOMEDICAL CORP.
    Date Cleared
    2009-07-24

    (88 days)

    Product Code
    GQG
    Regulation Number
    866.3480
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RAMP RSV ASSAY

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

    The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) F-protein antigens in nasal wash/aspirate, nasopharyngeal aspirate and nasopharyngeal swab samples. It is an in vitro diagnostic assay that aids in the rapid diagnosis of RSV infections in symptomatic patients 21 years of age and younger. A negative test is presumptive and it is recommended that all negative results be confirmed by cell culture or direct specimen fluorescence assay (DSFA). Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional use.

    Device Description

    The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples from symptomatic patients 21 years of age and younger. A wash/aspirate or swab sample is mixed with Sample buffer and applied into the sample well of the Test Cartridge. The sample migrates along the strip. Fluorescent-dyed latex (test) particles. coated with anti-RSV antibodies bind to RSV antigens, if present in the sample. As the sample migrates along the strip, RSV-bound particles are captured at the RSV detection zone, and additional particles are captured at the internal standard zone.

    AI/ML Overview

    This document describes the RAMP® RSV Assay, a qualitative immunochromatographic test for detecting Respiratory Syncytial Virus (RSV). The study presented focuses on its analytical and clinical performance.

    Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance MetricAcceptance Criteria (Implied/Standard for Assay)Reported Device Performance
    Analytical Performance
    Analytical Sensitivity (LoD)Device should detect RSV at low concentrationsRanged from 3.5x10^2 to >1.7x10^5 TCID50/mL depending on strain and sample matrix. Achieved 90-100% positivity for LoD samples.
    Precision & ReproducibilityHigh agreement across sites and operators99.2% overall agreement with expected results. RAMP Ratio %CV 13-16%.
    InterferenceNo interference from common substancesNone of the tested interfering substances (whole blood, mucin, various medications/OTC products) interfered with negative or positive RSV results.
    Analytical SpecificityNo cross-reactivity with common viruses/bacteriaNone of the 16 viruses and 17 bacteria tested gave a positive result.
    Transport Media CompatibilityNo interference with common transport mediaNone of the 7 transport media tested interfered with performance.
    Swab Material CompatibilityNo interference with common swab typesNone of the 4 swab materials tested interfered with performance.
    Clinical Performance
    Overall SensitivityReasonable sensitivity for RSV detection87.3%
    Overall SpecificityHigh specificity for RSV detection95.6%
    Sensitivity (NP Swab, All Ages)88.2% (95% CI: 81.4 - 92.7)
    Specificity (NP Swab, All Ages)97.4% (95% CI: 94.6 - 98.7)
    Sensitivity (NP Swab, Age
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