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 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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Dario LC Blood Glucose Monitoring System. The relevant sections for acceptance criteria and study details are found primarily in the "Summary of Non-Clinical Data" and "Summary of Clinical Data" within the 510(k) Summary.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text:

Important Note: The provided text is a summary (510(k) Summary) and does not contain the full details of the studies. Therefore, specific numerical acceptance criteria (e.g., exact precision targets, linearity ranges, etc.) and comprehensive study methodologies (like detailed sample sizes for specific tests, expert qualifications, or adjudication methods) are not explicitly stated. The document focuses on confirming that testing was done and the device "meets all of its associated specifications" or "successfully passed."

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Summary of Non-Clinical Data," the acceptance criteria are implicitly linked to the "associated specifications" for each tested category. The performance is stated as meeting these specifications or successfully passing the tests.

Acceptance Criterion (Implicit)	Reported Device Performance
In Vitro performance meets all associated specifications	Proposed Dario LC Blood Glucose Monitoring System has been tested for in vitro performance and meets all of its associated specifications.
Software documentation in accordance with FDA Guidance (moderate level of concern)	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 meets IEC 60601-1 relevant sections	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 meets relevant sections	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.
Repeatability Precision meets specified targets	Assessed and confirmed the proposed device to be substantially equivalent to the predicate device.
Intermediate Precision meets specified targets	Assessed and confirmed the proposed device to be substantially equivalent to the predicate device.
Linearity meets specified targets	Assessed and confirmed the proposed device to be substantially equivalent to the predicate device.
Operating Conditions performance meets specified targets	Assessed and confirmed the proposed device to be substantially equivalent to the predicate device.
Environmental Conditions performance meets specified targets	Assessed and confirmed the proposed device to be substantially equivalent to the predicate device.
Hardware performance meets specified targets	Assessed and confirmed the proposed device to be substantially equivalent to the predicate device.
Communication Accuracy performance meets specified targets	Assessed and confirmed the proposed device to be substantially equivalent to the predicate device.
Clinical performance demonstrated through User Evaluation and Method Comparison study showing substantial equivalence	A User Evaluation and Method Comparison study was completed... This evaluation confirmed the proposed device to be substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- In Vitro Testing (Repeatability, Intermediate Precision, Linearity, Operating Conditions, Environmental Conditions, Hardware, Communication Accuracy): Not explicitly stated. The summary only says these were "assessed."
- Clinical Data (User Evaluation and Method Comparison study): Not explicitly stated. The summary only mentions "A User Evaluation and Method Comparison study was completed."
Data Provenance (e.g., country of origin of the data, retrospective or prospective):
- The submitter, LabStyle Innovation, Ltd., is located in Caesarea, Israel. This suggests the studies may have been conducted in Israel or a location convenient for the manufacturer.
- The "User Evaluation and Method Comparison study" implies a prospective study involving human subjects.
- Other performance tests (In Vitro, Electrical Safety, EMI) are laboratory-based and inherently prospective for the device under evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable for this device type (blood glucose monitor). Ground truth for a blood glucose monitor is typically established by comparative measurements against a laboratory reference method (e.g., YSI analyzer) or a predicate device, not by expert consensus on image interpretation or similar qualitative assessments.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is quantitative measurement against a reference, not subject to human interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a standalone diagnostic measurement system, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers. The "Dario App" is described as merely the "display component of the Dario LC Blood Glucose Monitoring System," providing an "external display for the user to review blood glucose testing results." It does not perform "any diagnostic or clinical analysis function."

6. If a Standalone (i.e. Algorithm only without human-in-the loop performance) was done

The device itself is a standalone (algorithm only) measurement system. The performance assessments listed (In Vitro, Repeatability Precision, Linearity, Electrical Safety, EMI, Communication Accuracy) evaluate the device's inherent performance. The "User Evaluation" aspect would typically relate to usability and user performance in obtaining a measurement, but the core accuracy is independent of the user interface per se, as the app is only a display. The clinical study confirmed the device's performance as used but the underlying measurement is standalone.

7. The Type of Ground Truth Used

For the In Vitro performance, Repeatability, Intermediate Precision, Linearity, Communication Accuracy, the presumed ground truth is a highly accurate laboratory reference method for glucose measurement (e.g., YSI 2300 STAT Plus Glucose & L-Lactate Analyzer, often considered a gold standard for glucose in blood). The summary states the device "meets all of its associated specifications," implying comparison to such a reference.
For the User Evaluation and Method Comparison study, the ground truth would be established by comparing the Dario LC Blood Glucose Monitoring System's readings to those obtained from a laboratory reference method or the legally marketed predicate device (Dario Blood Glucose Monitoring System K150817) on the same blood samples. The goal was to prove "substantial equivalence."

8. The Sample Size for the Training Set

No information about a "training set" is provided. This terminology is typically associated with machine learning or AI models. Given that the Dario LC is a blood glucose monitoring system, it likely uses established electrochemical measurement principles rather than a trainable algorithm in the AI sense. Therefore, there wouldn't be a "training set" in the context of typical AI device development. The device's internal calibration and algorithms would be developed and validated internally by the manufacturer, not "trained" on a dataset in the way an AI model is.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there's no indication of a "training set" in the context of an AI/ML model for this device.

Summary

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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

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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

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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 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 Innovation8 Hatokhen StreetNorth Industrial ParkCaesarea 3088900Israel
Contact Person:	Tracey H. WielinskiPresidentQualtra 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
ClassificationName:	System, Test, Blood Glucose, Over The Counter
Predicate Device:	Dario Blood Glucose Monitoring SystemK150817
DeviceDescription:	The Dario LC Blood Glucose Monitoring System is acompact, all-in-one blood glucose meter that is used inconjunction with a smart mobile device (SMD). The DarioLC meter is connected to a SMD through an AppleLightning® connector in order to provide the glucose meterwith power. The SMD also provides an external display forthe user to review blood glucose testing results via a mobileapplication downloaded to the SMD. The full process ofblood glucose measurement is done on the glucose meter; theSMD does not provide any diagnostic or clinical analysisfunction. When connected to a SMD, the Dario LC glucosemeter is agnostic both to the platform of the smart mobiledevice and to the model of the individual SMD within aplatform.
Statement ofIntended Use:	The Dario LC Blood Glucose Monitoring System is intendedfor the quantitative measurement of glucose (sugar) in freshcapillary whole blood. The Dario is intended for self-testingoutside the body (in vitro diagnostic use) by people withdiabetes at home to monitor the effectiveness of their diabetescontrol.
Statement ofIndications for Use:	The Dario LC Blood Glucose Monitoring System consists ofthe Dario LC Blood Glucose Meter, Dario Glucose TestStrips, Dario Glucose Control Solutions and the Dario App asthe display component of the Dario LC Blood GlucoseMonitoring System. The Dario LC Blood Glucose MonitoringSystem is intended for the quantitative measurement ofglucose (sugar) in fresh capillary whole blood samples drawnfrom the fingertips. The Dario LC Blood Glucose MonitoringSystem is intended to be used by a single person and shouldnot be shared.
	The Dario LC Blood Glucose Monitoring System is intendedfor self-testing outside the body (in vitro diagnostic use) bypeople with diabetes at home to monitor the effectiveness ofdiabetes control. The Dario LC Blood Glucose MonitoringSystem should not be used for the diagnosis of or screening ofdiabetes or for neonatal use.
	The Dario Blood Glucose Test Strips are for use with theDario LC Blood Glucose Meter to quantitatively measureglucose (sugar) in fresh capillary whole blood samples drawnfrom the fingertip.
Summary ofTechnologicalCharacteristics:	The proposed device has the same technologicalcharacteristics and is equivalent in design and configuration ascompared to the predicate device.
Summary of Non-Clinical Data:	The following performance and safety testing has confirmedthe proposed device to be substantially equivalent to thepredicate device:
	• In Vitro: the proposed Dario LC Blood GlucoseMonitoring System has been tested for in vitroperformance and meets all of its associatedspecifications;
	• Software: documentation was prepared and submittedfor a moderate level of concern device in accordancewith 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

Regulation Number and Section

§ 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.