(251 days)
No
The document explicitly states that the smart mobile device (SMD) "does not provide any diagnostic or clinical analysis function," and there are no mentions of AI, DNN, or ML in the text.
No.
A therapeutic device is one that treats or heals a condition. This device is an in vitro diagnostic device used for monitoring blood glucose levels, not for therapy.
Yes
Explanation: The device is described as "in vitro diagnostic use" for monitoring glucose levels in individuals with diabetes, which is a diagnostic purpose to assess the effectiveness of diabetes control.
No
The device description explicitly states that the system includes a "Dario meter" which is a physical component that performs the blood glucose measurement. The software (Dario App) acts as a display and interface, but the core measurement is done by the hardware meter.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control."
- Measurement of Analytes: The system is designed for the "quantitative measurement of glucose (sugar)" in blood samples. Measuring analytes in biological samples is a core function of IVDs.
- Testing Outside the Body: The phrase "self-testing outside the body (in vitro diagnostic use)" directly indicates that the testing is performed on samples taken from the body, rather than directly on the body itself.
The device description and performance studies further support this classification by detailing how the system measures glucose from blood samples and the testing performed to ensure its accuracy and safety for this purpose.
N/A
Intended Use / Indications for Use
The Dario Blood Glucose Monitoring System consists of the Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component of the Dario Blood Glucose Monitoring System. The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Dario Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Dario Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
Product codes
NBW
Device Description
The Dario Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario meter is connected to a SMD through a standard 3.5mm audio plug in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes at home
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 following performance and safety testing has confirmed the proposed device to be substantially equivalent to the predicate device:
- In Vitro: the proposed Dario Blood Glucose Monitoring System has been tested for in vitro performance and meets all of its associated specifications;
- Software: documentation was prepared and submitted for a moderate level of concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices;
- Electrical Safety: the proposed Dario Blood Glucose Monitoring System has been tested and successfully passed all of the relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety;
- Electromagnetic Interference: the proposed Dario Blood Glucose Monitoring System has been tested and successfully met all of the relevant sections (Radiated emissions, Electrostatic discharge immunity test, radiated radio frequency, electromagnetic field immunity, and power frequency magnetic field immunity test) to satisfy compliance;
The following categories of performance were assessed and have confirmed the proposed device to be substantially equivalent to the predicate device: - Repeatability Precision
- Intermediate Precision
- Linearity
- Operating Conditions
- Altitude
- Accuracy
A User Performance study was completed for the expanded indications of the Dario Blood Glucose Monitoring System. This evaluation confirmed the proposed device to be substantially equivalent to the predicate device.
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2017
LABSTYLE INNOVATIONS, LTD. C/O TRACEY WIELINSKI, PRESIDENT QUALTRA CONSULTING, INC. 5 CASIE LANE PEPPERELL, MA 01463
Re: K163159
Trade/Device Name: Dario Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: June 15, 2017 Received: June 19, 2017
Dear Tracey Wielinski:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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/ResourcesforYou/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.
Sincerely.
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163159
Device Name Dario Blood Glucose Monitoring System
Indications for Use (Describe)
The Dario Blood Glucose Monitoring System consists of the Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component of the Dario Blood Glucose Monitoring System. The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Dario Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Dario Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
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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510(k) Summary
| Submitter: | LabStyle Innovations
9 Halamish Street
North Industrial Park
Caesarea 3890000
Israel |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tara N. Turney
Regulatory Consultant
Qualtra Consulting, Inc
Telephone: +852-5964-8211
E-mail: tara@mydario.com |
| Date Prepared: | July 18, 2017 |
| Trade Name: | Dario® Blood Glucose Monitoring System |
| Common Name: | Glucose Test System |
| Regulation: | 21 § 862.1345 |
| Product Code: | NBW |
| Classification
Name: | System, Test, Blood Glucose, Over The Counter |
| Predicate Device: | Dario Blood Glucose Monitoring System
K150817 |
| Device
Description: | The Dario Blood Glucose Monitoring System is a compact,
all-in-one blood glucose meter that is used in conjunction with
a smart mobile device (SMD). The Dario meter is connected
to a SMD through a standard 3.5mm audio plug in order to
provide the glucose meter with power. The SMD also
provides an external display for the user to review blood
glucose testing results via a mobile application downloaded to
the SMD. The full process of blood glucose measurement is
done on the glucose meter; the SMD does not provide any
diagnostic or clinical analysis function. When connected to a
SMD, the Dario glucose meter is agnostic both to the platform
of the smart mobile device and to the model of the individual
SMD within a platform. |
| Statement of
Intended Use: | The Dario Blood Glucose Monitoring System is intended for
the quantitative measurement of glucose (sugar) in fresh |
| | capillary whole blood. The Dario is intended for self-testing
outside the body (in vitro diagnostic use) by people with
diabetes at home to monitor the effectiveness of their diabetes
control. |
| Statement of
Indications for Use: | The Dario Blood Glucose Monitoring System consists of the
Dario Blood Glucose Meter, Dario Glucose Test Strips, Dario
Glucose Control Solutions and the Dario App as the display
component of the Dario Blood Glucose Monitoring System.
The Dario Blood Glucose Monitoring System is intended for
the quantitative measurement of glucose (sugar) in fresh
capillary whole blood samples drawn from the fingertips. The
Dario Blood Glucose Monitoring System is intended to be
used by a single person and should not be shared. |
| | The Dario Blood Glucose Monitoring System is intended for
self-testing outside the body (in vitro diagnostic use) by
people with diabetes at home to monitor the effectiveness of
diabetes control. The Dario Blood Glucose Monitoring
System should not be used for the diagnosis of or screening of
diabetes or for neonatal use. |
| | The Dario Blood Glucose Test Strips are for use with the
Dario Blood Glucose Meter to quantitatively measure glucose
(sugar) in fresh capillary whole blood samples drawn from the
fingertip. |
| Summary of
Technological
Characteristics: | The proposed device has the same technological
characteristics and is identical in design and configuration as
compared to the predicate device. |
| Summary of Non-
Clinical Data: | The following performance and safety testing has confirmed
the proposed device to be substantially equivalent to the
predicate device: |
| | • In Vitro: the proposed Dario Blood Glucose
Monitoring System has been tested for in vitro
performance and meets all of its associated
specifications; |
| | • Software: documentation was prepared and submitted
for a moderate level of concern device in accordance
with FDA's Guidance for the Content of Premarket
Submissions for Software Contained in Medical
Devices; |
| | • Electrical Safety: the proposed Dario Blood Glucose
Monitoring System has been tested and successfully |
| Summary of
Clinical Data: | A User Performance study was completed for the expanded
indications of the Dario Blood Glucose Monitoring System.
This evaluation confirmed the proposed device to be
substantially equivalent to the predicate device. |
| Conclusion from
Data: | LabStyle Innovations has demonstrated that the proposed
Dario Blood Glucose Monitoring System is substantially
equivalent to the predicate device based upon indications for
use, design, test results and the same fundamental scientific
technology. |
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passed all of the relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety;
-
. Electromagnetic Interference: the proposed Dario Blood Glucose Monitoring System has been tested and successfully met all of the relevant sections (Radiated emissions, Electrostatic discharge immunity test, radiated radio frequency, electromagnetic field immunity, and power frequency magnetic field immunity test) to satisfy compliance;
The following categories of performance were assessed and have confirmed the proposed device to be substantially equivalent to the predicate device: -
Repeatability Precision
-
. Intermediate Precision
-
Linearity
-
Operating Conditions .
-
. Altitude
-
Accuracy ●