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510(k) Data Aggregation

    K Number
    K173915
    Device Name
    Test of Variables of Attention (T.O.V.A.)
    Manufacturer
    The TOVA Company
    Date Cleared
    2018-03-22

    (90 days)

    Product Code
    LQD, LOD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LQD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
    Device Description
    The Test of Variables of Attention (T.O.V.A.) is an accurate and objective continuous performance test (CPT) that measures the key components of attention and inhibitory control. The T.O.V.A. is used by qualified healthcare professionals in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD), in children and adults. In addition, the visual T.O.V.A. is used to evaluate treatment for attention deficits, including ADHD. The T.O.V.A. is a culture- and language-free, sufficiently long computerized test that requires no left/right discrimination or sequencing. Responses to visual or auditory stimuli are recorded with a specially designed, highly accurate (±1 ms) microswitch. The T.O.V.A. calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). These calculations are then compared to a large age- and gender-matched normative sample (over 1,700 individuals for the visual test, and over 2,500 individuals for the auditory test), as well as to a sample population of individuals independently diagnosed with ADHD. These comparison results are used to create an immediately available, easy-to-read report. The T.O.V.A. system includes: a USB flash drive with software installer for Mac and Windows PCs, a T.O.V.A. USB device, a T.O.V.A. Microswitch, an Installation Guide, a User's Manual, a Clinical Manual, and accessory cables (USB, VGA, and audio cables).
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    K Number
    K170082
    Device Name
    Test of Variables of Attention (T.O.V.A.) Version 9.0
    Manufacturer
    THE TOVA COMPANY
    Date Cleared
    2017-05-17

    (127 days)

    Product Code
    LQD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LQD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals with objective measurements of attention and inhibitory control, which aid in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD). T.O.V.A. results should only be interpreted by qualified healthcare professionals.
    Device Description
    The Test of Variables of Attention (T.O.V.A.) is an accurate and objective continuous performance test (CPT) that measures the key components of attention and inhibitory control. The T.O.V.A. is used by qualified healthcare professionals in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD), in children and adults. The T.O.V.A. is a culture- and language-free, sufficiently long computerized test that requires no left/right discrimination or sequencing. Responses to visual or auditory stimuli are recorded with a specially designed, highly accurate (±1 ms) microswitch. The T.O.V.A. calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). These calculations are then compared to a large age- and gender-matched normative sample (over 1,700 individuals for the visual test, and over 2,500 individuals for the auditory test), as well as to a sample population of individuals independently diagnosed with ADHD. These comparison results are used to create an immediately available, easy-to-read report. The T.O.V.A. system includes: a USB flash drive with software installer for Mac and Windows PCs, a T.O.V.A. USB device, a T.O.V.A. Microswitch, an Installation Guide, a User's Manual, a Clinical Manual, and accessory cables (USB, VGA, and audio cables).
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    K Number
    K143468
    Device Name
    QbCheck
    Manufacturer
    QBTECH AB
    Date Cleared
    2016-03-22

    (474 days)

    Product Code
    LQD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LQD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QbCheck provides health care professionals with objective measurements of hyperactivity, and inattention to aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD. Q6Check results should be interpreted only by qualified health care professionals.
    Device Description
    QbCheck is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity of an individual to pay attention to visual stimuli and inhibit impulses. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD); impaired attention, hyperactivity and impulsivity. QbCheck provides an accurate and reproducible measure of an individual's capacity in each of these three domains by utilizing a consistent challenge paradigm coupled with detailed real-time measurements of behavior and performance. The fundamental core of QbCheck is a computer-assisted attention and impulse control task and simultaneous recording of activity. QbCheck is an online solution and no extra hardware is needed as the test is performed on the user's own computer. For the activity tracking analysis QbCheck uses the built in camera in the user's laptop or a separate web camera on the user's desktop computer. QbCheck consists of the following; ● QbCheck client and server software . Online test with instructions, a continuous performance task (CPT) and motion measurement technology through web camera. - Access to a remote server which generates test results . - Secure access to a result report - User manual ● - Technical manual - QbCheck Behavior Observation Form .
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    K Number
    K141865
    Device Name
    DANA
    Manufacturer
    ANTHROTRONIX, INC
    Date Cleared
    2014-10-15

    (97 days)

    Product Code
    LQD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LQD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state. Factors that may affect the measurement of reaction time include, but are not limited to concussion, head injury, insomnia, post traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), memory impairment, delirium, prescription and non-prescription medication, some nutritional supplements, as well as a variety of psychological states (e.g. fatigue and stress). DANA also delivers and scores standardized psychological questionnaires. DANA results should be interpreted only by qualified professionals.
    Device Description
    DANA is a mobile application indicated to provide clinicians with objective measurements of reaction time (speed and accuracy) and standardized health assessments to aid in the assessment of an individual's medical or psychological state. DANA results should be interpreted only by qualified professionals. DANA was developed on a mobile platform to improve the access and availability of reaction time tests and standardized health assessments through (1) custom configuration of the system by clinicians based on their need and discretion; and (2) allowing for objective health assessments both in-clinic and out-of-clinic settings.
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    K Number
    K133382
    Device Name
    QB TEST
    Manufacturer
    QBTECH AB
    Date Cleared
    2014-03-24

    (140 days)

    Product Code
    LQD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LQD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QbTest provides clinicans with objective measurements of hyperactivity, and inatention to aid in the clinical assessment of ADHD (Attention Deficit Hyperactivity Disorder) an interentions in patients with ADHD. QbTest results should be interpreted only by qualified professionals.
    Device Description
    QbTest is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity of an individual to pay attention to visual stimuli and inhibit impulses. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD): impaired attention, hyperactivity and impulsivity. QbTest provides an accurate and reproducible measure of an individual's capacity in each of these three domains by utilizing a consistent challenge paradigm coupled with detailed real-time measurements of behavior and performance. The fundamental core of QbTest is a computer-assisted attention and impulse control task and simultaneous recording of activity using an infrared camera for motion measurements. The system consists of the following components: - · Client software - · Responder button (also referred to as responder unit) - · Infrared camera - · Reflective motion marker - · User manual - Technical manual - · Stimulus card - · Camera stand - · Measuring tape - · QbTest Behavior Rating Scale - · In addition, the user must have access to a remote server that generates test reports
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    K Number
    K122149
    Device Name
    QBTES
    Manufacturer
    QBTECH AB
    Date Cleared
    2012-10-17

    (90 days)

    Product Code
    LQD, QBT
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LQD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QbTest is indicated to be used to aid in the clinical assessment of ADHD. QbTest results should be interpreted by qualified health care professionals only. QbTest provides clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD. QbTest results should be interpreted only by qualified professionals.
    Device Description
    QbTest is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity for an individual to pay attention to visual stimuli and inhibit impulses. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD); impaired attention, hyperactivity and impulsivity. QbTest provides an accurate and reproducible measure of an individual's capacity in each of these three domains by utilizing a consistent challenge paradigm coupled with detailed real-time measurements of behavior and performance. The fundamental core of QbTest is a computer-assisted attention and impulse control task and simultaneous recording of activity using an infrared camera for motion measurements. The system consists of the following components: - Client software - Responder button (also referred to as responder unit) - Infrared camera - Reflective motion marker - User manual - Technical manual - Stimulus card - Camera stand - Measuring tape - QbTest Behaviour Rating Scale - In addition, the user must have access to a remote server that generates test reports
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    K Number
    K040894
    Device Name
    QBTEST
    Manufacturer
    QBTECH AB
    Date Cleared
    2004-06-22

    (77 days)

    Product Code
    LQD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LQD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QbTest provides clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD. QbTest results should be interpreted only by qualified professionals.
    Device Description
    The QbTest is a 15 minute, non invasive test that has been developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli while inhibiting their loco motor activity and controlling their urge to respond impulsively. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD) impaired attention, hyperactivity and impulsivity. QbTest provides an accurate and reproducible measure of a child's capacity in each of these three domains by utilizing a consistent challenge paradigm coupled with detailed real-time measurements of behavior and performance. The fundamental core of QbTest is a computer-administered go/not-go vigilance response task combined with motion capture. The system consists of the following components; • Client PC software • Connection box • Responder button • Camera for motion measurement • Reflective marker • USB and serial cable
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    K Number
    K020800
    Device Name
    OPTAX SYSTEM
    Manufacturer
    OPTAX SYSTEMS, INC.
    Date Cleared
    2002-06-10

    (90 days)

    Product Code
    LQD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LQD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OPTAx System provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OPTAx results should be interpreted only by qualified professionals.
    Device Description
    OPTAx (Optical Tracking and Attention test) is a 15 minute non-invasive, office-based test that was developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli, while inhibiting their locomotor activity and controlling their impulsive responses. The three core symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) are : impaired inattention, hyperactivity, and impulsivity. OPTAx provides an accurate and reproducible measure of a child's capacity in each of these three domains by utilizing a consistent challenge paradigm, coupled with detailed real-time measurements of behavior and performance. The fundamental core of OPTAx is a computer-administered GO/NO-GO vigilance response task. The OPTAx System consists of the following components: - . IMac computer and peripherals (printer and adapters) - Pre-installed OPTAx software program ● - . Motion analysis camera and peripherals - Data analysis software on the OPTAx secure server .
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