(269 days)
No
The summary describes a standard blood glucose monitoring system that uses an electrochemical test principle and a mobile application for displaying results. There is no mention of AI or ML being used for data analysis, interpretation, or any other function. The "internal algorithm" mentioned is likely a simple calculation based on the electrical current generated by the test strip reaction.
No.
This device is an in vitro diagnostic device used to measure blood glucose levels, which aids in monitoring the effectiveness of diabetes control. It does not directly treat or cure a disease or condition, which is characteristic of a therapeutic device.
No
Explanation: The "Intended Use" section explicitly states that "The Dario Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use." This indicates it is not a diagnostic device.
No
The device description explicitly states that the system consists of a device housing that includes a blood glucose meter and lancing device, along with test strips, lancets, and control solutions, in addition to the mobile application. This indicates the presence of significant hardware components beyond just software.
Yes, the Dario Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic) device.
Here's why, based on the provided text:
- Explicit Statement: 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)..."
- Device Description: The "Device Description" section also reiterates: "The Dario is intended for self-testing outside the body (in vitro diagnostic use)..."
- Test Principle: The "Test Principle" section describes the device as "an in vitro diagnostic device intended for the measurement of glucose in fresh whole capillary blood."
- Function: The device measures glucose in a biological sample (blood) outside the body to provide information about a person's health status (diabetes control). This is the core function of an in vitro diagnostic device.
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.
The Dario Glucose Control Solutions are for use with the Dario Blood Glucose Meter and the Dario Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
Product codes
NBW. CGA. JJX
Device Description
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 diabetes control.
The Dario Blood Glucose Monitoring System consists of a device housing that includes a blood glucose meter and lancing device. The system also includes test strips, lancets, control solutions and a mobile application. The Dario meter does not require coding or separate batteries. The Dario meter is powered via the 3.5mm audio headphone jack of the smart mobile device. Users are instructed to insert the test strip into the meter, apply the blood or control solution to the test strip, after which the meter will process the test in approximately six (6) seconds and display the test result on the smart mobile device screen via the mobile application.
The Dario Blood Glucose Monitoring System uses Apple's iOS smart mobile device technology to view the glucose test results via a mobile application. This application is available for download via the smart mobile device's application store.
Test Principle:
The Dario Blood Glucose Monitoring System is an in vitro diagnostic device intended for the measurement of glucose in fresh whole capillary blood. The principle of the test relies upon a reaction between a specific type of sugar (glucose) in the blood sample and the glucose oxidase in the test strip. This reaction generates a small electrical current, which is measured by the meter. The meter calculates the blood glucose level based on an internal algorithm. The Dario application displays the test result via the smart mobile device display.
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
People with diabetes at home. Intended for self-testing.
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)
System Accuracy:
Study Type: System accuracy study determined according to ISO 15197:2003.
Sample Size: 100 samples with glucose concentrations ranging from 24 to 479 mg/dL. Three (3) test strip lots and six (6) Dario meters used, totalling 600 tests.
Key Results: 100% of individual glucose results fell within 15 mg/dL of the YSI reference at glucose concentrations
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2015
LABSTYLE INNOVATIONS LTD. TRACEY WIELINSKI OFFICIAL CORRESPONDENT 3521 HATWYNN RD. CHARLOTTE NC 28269
Re: K150817
Trade/Device Name: Dario Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA. JJX Dated: November 20, 2015 Received: November 23, 2015
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 (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.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), 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" (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.
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 yours,
Katherine Serrano -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
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Indications for Use
510(k) Number (if known)
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.
The Dario Glucose Control Solutions are for use with the Dario Blood Glucose Meter and the Dario Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
| 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
(As required by 21.CFR.807.92)
1. SUBMITTER
| Manufacturer: | LabStyle Innovation Ltd.
9 Halamish St.
North Industrial Park
Caesarea 389000, Israel |
|-----------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Tracey Wielinski
Qualtra Consulting, Inc.
5 Casie Lane
Pepperell, MA 01463
USA |
| | Phone: (440) 915-5833
Email: tracey@qualtraconsulting.com |
| Date Prepared: | December 10, 2015 |
2. DEVICE INFORMATION
| Device Name: | Dario® Blood Glucose Monitoring System |
|---|---|
| Common Name: | Blood Glucose Test System |
| Classification Name: | System, Test, Blood Glucose, Over The Counter |
| Regulation Section | Classification | Product Code | Panel |
|---|---|---|---|
| 21 CFR § 862.1345 | Class II | CGA, Glucose Oxidase, | |
| glucose | Clinical | ||
| Chemistry | |||
| (75) | |||
| 21 CFR § 862.1345 | Class II | NBW, system, test, blood | |
| glucose, over the counter | Clinical | ||
| Chemistry | |||
| (75) | |||
| 21 CFR § 862.1660 | Class I | JJX, Single (Specified) | |
| Analyte Controls (Assayed | |||
| and Unassayed) | Clinical | ||
| Chemistry | |||
| (75) |
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3. PREDICATE DEVICE
K131230 - Philosys Inc., Gmate SMART Blood Glucose Monitory System, Gmate SMART Application
4. DEVICE DESCRIPTION
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 diabetes control.
The Dario Blood Glucose Monitoring System consists of a device housing that includes a blood glucose meter and lancing device. The system also includes test strips, lancets, control solutions and a mobile application. The Dario meter does not require coding or separate batteries. The Dario meter is powered via the 3.5mm audio headphone jack of the smart mobile device. Users are instructed to insert the test strip into the meter, apply the blood or control solution to the test strip, after which the meter will process the test in approximately six (6) seconds and display the test result on the smart mobile device screen via the mobile application.
The Dario Blood Glucose Monitoring System uses Apple's iOS smart mobile device technology to view the glucose test results via a mobile application. This application is available for download via the smart mobile device's application store.
Test Principle:
The Dario Blood Glucose Monitoring System is an in vitro diagnostic device intended for the measurement of glucose in fresh whole capillary blood. The principle of the test relies upon a reaction between a specific type of sugar (glucose) in the blood sample and the glucose oxidase in the test strip. This reaction generates a small electrical current, which is measured by the meter. The meter calculates the blood glucose level based on an internal algorithm. The Dario application displays the test result via the smart mobile device display.
5. 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.
5
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.
The Dario Glucose Control Solutions are for use with the Dario Blood Glucose Meter and the Dario Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The indications for use and the base scientific technology of the Dario Blood Glucose Monitoring System are both similar to that of the predicate device. Both the subject device and the predicate are in vitro diagnostic devices intended for the measurement of glucose in capillary blood. Thev each use amperometry as the detection method and glucose oxidase as the enzyme in the test strip. Both the subject and predicate device use a smart mobile device to obtain power for the meter via the 3.5mm audio jack and display the blood glucose result in a mobile application.
The test principle for the Dario Blood Glucose Monitoring System and the predicate device are also similar. The principle of the test relies upon a reaction between glucose in the blood sample and the glucose oxidase in the test strip to produce a small electrical current. The meter measures this electrical current and calculates the blood glucose level via an internal algorithm. The Dario and the predicate both use the smart mobile device for the display of the results via a downloadable mobile application.
The performance testing data demonstrated that the subject device does not raise any new issues of safety and effectiveness. Therefore, based on the information provided in this submission, LabStyle Innovations concludes that the Dario Blood Glucose Monitoring System is substantially equivalent to the predicate device.
7. PERFORMANCE TESTING SUMMARY
The following performance data were provided in support of the substantial equivalence determination.
Software Verification and Validation Testing
Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction or a latent design flaw in the software device could lead to an erroneous result or a delay in delivery of appropriate medical care that would likely lead to minor injury.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Dario Blood Glucose Monitoring System. The system complies with IEC 61010-1 and EN 61010-2-101 standards for safety and EN 61326-1 and EN 61326-2-6 standards for EMC.
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The Dario Blood Glucose Monitoring System also complies with IEC 60601-1-2.
System Accuracy
System accuracy was determined according to ISO 15197:2003. The Dario Blood Glucose Monitoring System performance was assessed against a reference method. 100 samples with glucose concentrations ranging from 24 to 479 mg/dL were obtained and then tested with three (3) test strip lots and six (6) Dario meters with a total of 600 tests performed. Five (5) low concentration samples ranging of less than 50 mg/dL and five (5) high concentration samples of greater than 400 mg/dL were assessed.
The results showed that 100% of individual glucose results fell within 15 mg/dL of the YSI reference at glucose concentrations 4 |
| Uric Acid | > 11 |
| Acetaminophen | > 6 |
| Total bilirubin | > 35 |
| Triglycerides | > 810 |
| Cholesterol | > 455 |
| Galactose | > 60 |
9
| Ibuprofen | > 50 |
|---|---|
| Lactose | > 25 |
| Maltose | > 120 |
| Methyl-DOPA | > 2 |
| Xylose | > 50 |
Bench and Clinical Testing Summary
The design verification and validation testing of the subject device was performed in accordance with ISO 15197:2003. The Dario Blood Glucose Monitoring System met all system acceptance criteria.
8. CONCLUSION
The performance testing data demonstrates that the Dario Blood Glucose Monitoring System is substantially equivalent to the legally marketed predicate device. The Dario Blood Glucose Monitoring System does not raise any new questions of safety and effectiveness. Therefore, based on the information provided in this submission, it can be concluded that the Dario Blood Glucose Monitoring System has demonstrated substantial equivalence to the predicate device.