← Product Code LQD · K143468 # QbCheck (K143468) _Qbtech AB · LQD · Mar 22, 2016 · NE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K143468 ## Device Facts - **Applicant:** Qbtech AB - **Product Code:** LQD - **Decision Date:** Mar 22, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** NE - **Attributes:** Software as a Medical Device ## Indications for 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. ## Device Story QbCheck is an online, computer-assisted attention and impulse control task; measures capacity to pay attention to visual stimuli and inhibit impulses. Input: user performance on continuous performance task (CPT) via spacebar; motion data captured via standard laptop/desktop web camera. Operation: user performs test on own computer; software tracks motor activity and performance metrics. Output: quantitative report generated by remote server for healthcare professional review. Context: used in clinical settings to aid ADHD assessment and treatment monitoring. Benefit: provides objective, reproducible data on core ADHD domains (inattention, hyperactivity, impulsivity) to support clinical decision-making. ## Technological Characteristics Online software solution; utilizes standard computer hardware (web camera, keyboard). Employs continuous performance task (CPT) paradigm. Motion measurement via web camera-based computer vision. Connectivity: cloud-based (remote server for result generation). ## Predicate Devices - QbTest ([K133382](/device/K133382.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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)
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☐ Over-The-Counter Use (21 CFR 801 Subpart C)
| ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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. --- **Source:** [https://fda.innolitics.com/device/K143468](https://fda.innolitics.com/device/K143468) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com