Not Found
No
The description focuses on quantitative measurements and a normative database comparison, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is used to aid in the clinical assessment and diagnosis of ADHD, not to treat or alleviate the condition.
Yes
The device is indicated to "aid in the clinical assessment of ADHD" and provides "objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD", which directly points to its role in diagnosis.
No
The device description explicitly lists hardware components such as a responder button, infrared camera, and reflective motion marker, in addition to the client software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- QbTest Mechanism: QbTest is described as a "non-invasive test" that uses a computer-assisted attention and impulse control task and simultaneous recording of activity using an infrared camera. It measures behavioral and performance data.
- Lack of Biological Samples: The description does not mention the collection or analysis of any biological samples from the patient.
Therefore, QbTest falls outside the definition of an In Vitro Diagnostic device. It is a behavioral and performance assessment tool.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LQD
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 ofQbTest 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
6 and 60 years
Intended User / Care Setting
qualified health care 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)
The camera is tested in accordance with EN60825-1:1994. The System is tested in accordance with EN 60601-1 "Electrical Equipment, Part 1: General Safety Requirements" and EN 60601-1-2 "Electromedical equipment, EMC"
Normative tests have been gathered from several different cohorts resulting in a normative database of 1307 individuals between 6 and 60 years with an even age and gender distribution. The characteristics of this norm database and the methods to generate age and gender specific comparisons are described in the technical manual. There are four published studies which have evaluated the clinical validity of the QbTest for its intended use population. In addition, two test-retest studies have been completed to demonstrate the reliability of the QbTest.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
510(k) Summary
| Date: | 17 July |
|---|---|
| ------- | --------- |
OCT 1 7 2012
Qbtech AB 510(k) Submitter:
- Kungsgatan 29 11156 Stockholm Sweden Tel: +46 706339209 Fax: +46 8 Contact person: Hans Boström E-mail: hans bostrom@qbtech se
2012
Trade Name: QbTest
Classification name: Recorder, attention task performance
LQD Product Code:
QbTest (K040894) and Gordon Diagnostic System (K854903) Predicate Device:
| Descripti
on | Gordon
Diagnostic
System (K854903) | QbTest (K040894) | QbTest v3.5 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Gordon
Diagnostic System
(GDS) aids in the
diagnosis of
attention deficits,
especially Attention
Deficit Hyperactivity
Disorder (ADHD). It
provides reliable,
objective
information about
an individual's | QbTest (K040894)
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. | QbTest v3.5 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. |
1
| ability to sustain | |
|---|---|
| attention and exert | |
| self-control. | |
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
Indications for 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.
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.
Comparison of
QbTest is substantially equivalent to the original QbTest
2
| technological
characteristics to
predicate device: | (K040894).
It provides the same or similar functions and has a similar
design. Both the current version of QbTest and the
original version of QbTest (K040894) are indicated to aid
in the assessment of ADHD. Both provide objective
measurements of impulsivity, inattention and hyperactivity
to aid in this process. Both are microprocessor-based
vigilance task recorders with motion detection.
The current version of QbTest can also be used in
adolescents and adults as Gordon Diagnostic System
(K854903). |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing: | The camera is tested in accordance with EN60825-1:1994. The System
is tested in accordance with EN 60601-1 "Electrical Equipment, Part 1:
General Safety Requirements" and EN 60601-1-2 "Electromedical
equipment, EMC" |
| Clinical Testing: | Normative tests have been gathered from several different cohorts
resulting in a normative database of 1307 individuals between 6 and 60
years with an even age and gender distribution. The characteristics of
this norm database and the methods to generate age and gender
specific comparisons are described in the technical manual. There are
four published studies which have evaluated the clinical validity of the
QbTest for its intended use population. In addition, two test-retest
studies have been completed to demonstrate the reliability of the
QbTest. |
| Conclusions: | QbTest v3.5 is substantially equivalent to the original QbTest
(K040894). It provides the same or similar functions and has a similar
design. Both the original QbTest (K040894) and QbTest v3.5 are
indicated to aid in the assessment of ADHD. Both provide objective
measurements of impulsivity, inattention and hyperactivity to aid in this
process. Both are microprocessor-based vigilance task recorders with
motion detection. |
QbTest v3.5 can be used also in adolescents and adults as can the Gordon Diagnostic System (K854903).
3
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed device identified above.
.
:
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 17 2012
Qbtech AB % Mr. Hans Bostrom Medical Director Kungsgatan 29 11156 Stockholm Sweden
Re: K122149
Trade/Device Name: QbTest v3.5 Regulation Number: Unclassified Regulation Name: Recorder, Attention Task Performance Regulatory Class: Class II Product Code: · LQD Dated: July 17, 2012 Received: July 19, 2012
Dear Mr. Bostrom:
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.
5
Page 2 - Mr. Hans Bostrom
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Debra Falls
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
STATEMENT FOR INDICATIONS FOR USE
510 (k) Number (if known):
Device Name:
QbTest
Indications for Use:
QbTest provides clinicians with objective measurements of hyperactivity, and inattention to aid in the clinical assessment of ADHD. QbTest results should be interpreted only by qualified professionals.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 GFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K122149