(193 days)
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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 provided text. The device description focuses on the meter performing the measurement and the SMD acting as a display.
No
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating or preventing a disease.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Dario LC Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use." It is intended for monitoring diabetes control by people with diabetes, not for diagnosis.
No
The device description explicitly states that the system includes a "Dario LC blood glucose meter" which is a hardware component used for the measurement of glucose. The software (Dario App) acts as a display component and does not perform the core measurement function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The Dario LC Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)..."
- Nature of the Test: The system measures glucose in a blood sample outside the body, which is the definition of an in vitro test.
- Purpose: The purpose is to monitor the effectiveness of diabetes control, which is a diagnostic purpose related to a medical condition.
N/A
Intended Use / Indications for Use
The Dario LC Blood Glucose Monitoring System consists of the Dario LC Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component of the Dario LC 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 LC 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 LC 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 LC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The Dario LC 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 LC meter is connected to a SMD through an Apple Lightning® connector 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 LC 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fingertips
Indicated Patient Age Range
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A User Evaluation and Method Comparison study was completed for the proposed Dario LC 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.)
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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.
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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).
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§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 23, 2018
LabStyle Innovation, Ltd. % Tracey Wielinski President Qualtra Consulting 5 Casie Lane Pepperell, MA 01463
Re: K172723
Trade/Device Name: Dario LC Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: February 17, 2018 Received: February 22, 2018
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 Part 801 and Part 809); medical device 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
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
Enclosure
2
Indications for Use
510(k) Number (if known) K172723
Device Name Dario LC Blood Glucose Monitoring System
Indications for Use (Describe)
The Dario LC Blood Glucose Monitoring System consists of the Dario LC Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component of the Dario LC 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 LC 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 LC 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 LC 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 – K172723
| Submitter: | LabStyle Innovation
8 Hatokhen Street
North Industrial Park
Caesarea 3088900
Israel |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracey H. Wielinski
President
Qualtra Consulting, Inc |
| | Telephone: (440) 915-5833 |
| | E-mail: tracey@qualtraconsulting.com |
| Date Prepared: | March 22, 2018 |
| Trade Name: | Dario® LC 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 LC 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
LC meter is connected to a SMD through an Apple
Lightning® connector 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 LC 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 LC 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 withdiabetes at home to monitor the effectiveness of their diabetes
control. |
| Statement of
Indications for Use: | The Dario LC Blood Glucose Monitoring System consists of
the Dario LC Blood Glucose Meter, Dario Glucose Test
Strips, Dario Glucose Control Solutions and the Dario App as
the display component of the Dario LC Blood Glucose
Monitoring System. The Dario LC 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 LC Blood Glucose Monitoring
System is intended to be used by a single person and should
not be shared. |
| | The Dario LC 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 LC 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 LC 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 equivalent 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 LC 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 |
| Summary of Clinical Data: | A User Evaluation and Method Comparison study was completed for the proposed Dario LC Blood Glucose Monitoring System. This evaluation confirmed the proposed device to be substantially equivalent to the predicate device. |
| Conclusion from Data: | LabStyle Innovation has demonstrated that the proposed Dario LC Blood Glucose Monitoring System is substantially equivalent to the predicate device based upon indications for use, design, test results and the same fundamental scientific |
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Submissions for Software Contained in Medical Devices;
- . Electrical Safety: the proposed Dario LC 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 LC 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 ●
- Environmental Conditions
- Hardware
technology.
- . Communication Accuracy