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    K Number
    K143236
    Device Name
    Theranos Herpes Simplex Virus-1 IgG Assay
    Manufacturer
    THERANOS, INC.
    Date Cleared
    2015-07-02

    (232 days)

    Product Code
    MXJ
    Regulation Number
    866.3305
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K000238
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERANOS, INC.

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

    The Theranos™ HSV-1 IgG Assay is a chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum, in K2-EDTA anticoagulated human plasma from venous blood, and in human fingerstick K2-EDTA anticoagulated whole blood obtained with the Theranos Capillary Tubes and Nanotainer Tubes. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 infection. The predictive value of positive and negative results depends on the population's prevalence and the pretest likelihood of HSV-1.

    The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients.

    The Theranos HSV-1 IgG Assay is for use with the Theranos System which performs automated sample processing steps and result analysis.

    Device Description

    The Theranos HSV-1 IgG Assay is for use with the Theranos System. The Theranos System performs automated sample processing steps and analysis to produce the test results.

    The Theranos HSV-1 IgG Assay is a three-step sandwich immunoassav with an HSV-1 glycoprotein G (gG) recombinant antigen coated surface, an anti-human IgG detection reagent conjugated to alkaline phosphatase (AP) and chemiluminescent substrate. During the first incubation step, the HSV-1 IgG antibodies present in the positive control and sample bind to the gG recombinant antigen on the coated surface. Following the first incubation step, unbound materials are removed with a wash cycle. Then the detection reagent-AP conjugate is added and during the second incubation step, the detection reagent-AP conjugate reacts with the HSV-1 IgG antibodies already bound to the capture surface. Following the second incubation, unbound materials are removed with a wash cycle. The chemiluminescent substrate is added to the capture-analyte-detection complex during the third incubation step to initiate the chemiluminescence reaction. Light generated by this reaction is detected and analyzed by the Theranos System using a calibration function to determine the cut-off index (COI) values for the sample and controls. The results for the Positive and Negative controls must be within specified limits for a run to be considered valid.

    AI/ML Overview

    The Theranos Herpes Simplex Virus-1 (HSV-1) IgG Assay is a chemiluminescent immunoassay for the qualitative detection of IgG antibodies to HSV-1 in human serum, K2-EDTA anticoagulated human plasma from venous blood, and human fingerstick K2-EDTA anticoagulated whole blood. It is intended to aid in the presumptive diagnosis of HSV-1 infection in sexually active individuals and expectant mothers.

    Here's an analysis of the acceptance criteria and supporting study details:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly state a consolidated table of acceptance criteria for all performance aspects. However, based on the studies described, we can infer some key criteria and the reported performance. The most critical performance metrics for a diagnostic assay like this are Sensitivity and Specificity in the intended use populations.

    Performance MetricAcceptance Criteria (Inferred from Study Design & Conclusions)Reported Device Performance (Sexually Active Adults)Reported Device Performance (Pregnant Women)Reported Device Performance (Low Prevalence Population)
    SensitivityNot explicitly stated but expected to be high for diagnostic aid. Implied acceptable range is within 95% Confidence Interval established by the study.95.1% (90.3-97.6% CI)97.9% (94.8-99.2% CI)97.0% (84.7-99.5% CI)
    SpecificityNot explicitly stated but expected to be high for diagnostic aid. Implied acceptable range is within 95% Confidence Interval established by the study.97.4% (92.7-99.1% CI)95.2% (89.3-98.0% CI)100% (92.7-100% CI)
    Precision (Venous Serum)Max %CV of 14.2% across different conditions (inferred from study conclusion).10.2% to 14.2%N/AN/A
    Precision (Fingerstick Whole Blood)Max %CV of 12.2% across different conditions (inferred from study conclusion).N/A10.9% to 12.2%N/A
    Reproducibility (Total Imprecision)%CV of 11.4% for COI >= 0.5, SD of 0.022 for COI 0.5)**0.5)**
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