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510(k) Data Aggregation

    K Number
    K223497
    Device Name
    Spectrum Saliva Collection Device
    Manufacturer
    Spectrum Solutions, LLC
    Date Cleared
    2023-02-17

    (88 days)

    Product Code
    QBD
    Regulation Number
    866.2950
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K202641
    Why did this record match?
    Device Name :

    Spectrum Saliva Collection Device

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

    The Spectrum Solutions Saliva Collection Device is designed for use in the non-invasive collection, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic device is intended to be used by a health care provider for samples suspected of containing SARS-CoV-2.

    Device Description

    The Spectrum Solutions Saliva Collection device consists of a plastic tube designed for the collection of human saliva samples, a funnel, a cap with a stem flare, and a fluid chamber containing Spectrum's inactivating media. Sample collection is conducted under the supervision of a Health care provide. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the cap, the stabilizing solution is released into the tube and mixed with the saliva.

    AI/ML Overview

    The Spectrum Solutions Saliva Collection Device is a microbial nucleic acid storage and stabilization device designed for the non-invasive collection, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples, specifically for SARS-CoV-2.

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

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria CategorySpecific CriteriaReported Device PerformanceStudy Reference
    Limit of Detection (LoD)Greater than 95% accuracy for detecting 2/3 gene targets (ORF1ab, N gene, S gene) from SARS-CoV-2.20 GEC/reaction demonstrated 20/20 replicates (100% accuracy) for amplification of ORF1ab and N gene. (This is equivalent to 250 GEC/ml).Confirmatory LoD testing (Table 2)
    Sample Stability1. TaqPath COVID-19 assay detects 3 targets (Orf1ab, N gene, and S gene). A sample is considered positive if at least 2 of the 3 targets are amplified with Ct values
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