(474 days)
Not Found
No
The description focuses on a computer-assisted attention and impulse control task with real-time measurements and analysis, but does not mention AI or ML technologies. The analysis appears to be based on a consistent challenge paradigm and detailed measurements, not adaptive or learning algorithms.
No
The device aids in the clinical assessment and evaluation of treatment interventions for ADHD, but it does not directly treat the condition.
Yes
The device provides objective measurements to aid in the clinical assessment of ADHD, which falls under the definition of a diagnostic device. It quantifies aspects related to a medical condition to assist healthcare professionals in their diagnosis.
Yes
The device description explicitly states "QbCheck is an online solution and no extra hardware is needed as the test is performed on the user's own computer." It further clarifies that it uses the user's built-in or separate web camera for activity tracking, but the core of the device is the "QbCheck client and server software" and the "Online test". While it utilizes existing hardware (computer and camera), the medical device itself is the software that performs the attention and impulse control task and analyzes the data.
Based on the provided information, QbCheck is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD involves examining specimens such as blood, urine, tissue, etc., to provide information about a person's health.
- QbCheck is a behavioral and performance test. It assesses an individual's attention, hyperactivity, and impulsivity through a computer-assisted task and motion tracking using a camera. It does not analyze any biological samples.
- The intended use and device description clearly indicate a behavioral assessment tool. The focus is on observing and quantifying behavior and performance in response to visual stimuli and tasks.
Therefore, QbCheck falls outside the scope of an In Vitro Diagnostic device. It is a behavioral assessment tool used to aid in the clinical evaluation of ADHD.
N/A
Intended Use / Indications for 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.
Product codes
LQD
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
web camera
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2016
QbTech AB Hans Boström, MSc., PhD. Medical Director Kungsgatan 29 Stockholm, Sweden 11156
Re: K143468
Trade/Device Name: ObCheck Regulation Number: Unclassified Device Classification Name: Recorder, Attention Task Performance Regulatory Class: Unclassified Product Code: LQD Dated: March 14, 2016 Received: March 15, 2016
Dear Dr. Boström:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
William J.
Heetderks -A
Digitally sig
DN: c=US, o
ou=NIH, ou
0.9.2342.192
cn=William
Date: 2016.0
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143468
Device Name QbCheck
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary of Safety and Effectiveness
| Date: | December 3, 2014 |
|---|---|
| 510(k) Submitter: | Qbtech AB |
| Kungsgatan 29 | |
| 11156 Stockholm | |
| Sweden | |
| Tel: +46 706339209 | |
| Fax: +46 8 790 09 78 | |
| Contact person: Hans Boström | |
| E-mail: hans.bostrom@qbtech.com | |
| Trade Name: | QbCheck |
| Classification name: | Recorder, attention task performance |
| Product Code: | LQD |
| Predicate Device: | QbTest (K133382) |
| 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 |
4
. 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 .
Intended use: QbCheck provides healthcare professionals with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD. QbCheck results should be interpreted only by qualified healthcare professionals.
| Comparison of
technological
characteristics to
predicate device: | QbCheck is substantially equivalent to QbTest (K
K133382).
It provides the same functions and the test has an
identical design. Instead of a responder button, the t |
| --------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
esttaker uses the spacebar to respond to targets and instead of an infrared camera and a reflective motion marker, the test-takers motor activity during the test is registered by the web camera.