The On Call Sure Blood Glucose Monitoring System is comprised of the On Call Sure Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Blood Glucose Monitoring System is intended to the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Blood Glucose Monitoring System is intended for single-patient use and should not be shared.

The On Call Sure Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The On Call Sure Sync Blood Glucose Monitoring System is comprised of the On Call Sure Sync Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Sync Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Sync Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Sync Blood Glucose Monitoring System is intended for single-patient use and should not be shared.

The On Call Sure Sync Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Sync Blood Glucose Monitoring System is not intended for the diagnosis of or diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Device Description

The On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System are designed for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm, and/or palm.

Both systems have almost the same meter design and use the same strip and control solution. The only difference is that On Call Sure Sync Blood Glucose meter is embedded with a Bluetooth module which results in an additional Bluetooth data transfer feature for this meter. Thus, the On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System can be considered equivalent for the performance of glucose testing.

Both systems share the same On Call Sure Blood Glucose test strip. It has a reagent system that includes glucose dehydrogenase (FAD-GDH) and a mediator that reacts with the glucose in the whole blood sample to produce an electrical current signal. This current is measured using an amperometric detection method. The meter then calculates and displays the blood glucose concentration reading, calibrated to plasma reference. The On Call Sure / On Call Sure Sync Blood Glucose Meters are auto-coding.

Both systems consist of the On Call Sure / On Call Sure Sync Blood Glucose Meter, On Call Sure Blood Glucose Test Strips, and On Call Sure Clucose Control Solutions. Kits may be marketed with various combinations and quantities of the system components, or each of the components may be sold separately. All meter kits include a Carrying Case, User's Manual, Ouick Reference Guide, Warranty Card and Logbook. Materials needed but not provided include a single user lancing device and sterile lancets.

The On Call Sure Glucose Control Solutions are used to confirm that the meter and test strips are working properly. Glucose control solution(s) is/are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. Two control solution levels are available (Level 1 and Level 2). Level 1 is provided with the system. Level 2 is sold separately.

Both meters have a USB data transfer function that is inactive, pending validation with the On Call Diabetes Management Software (K131469). Only the On Call Sure Sync Blood Glucose Meter is equipped with Bluetooth.

The On Call Sure Sync Blood Glucose Meter is designed with a Bluetooth module which can send glucose test results to a mobile device if the glucose meter and the mobile device are paired and within range.

AI/ML Overview

The acceptance criteria and study proving the device meets them are detailed below based on the provided FDA 510(k) summary. The device in question is the ACON Laboratories, Inc. On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against the FDA Guidance for Industry and Food and Drug Administration Staff - Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (2016) regarding accuracy. The acceptance criteria for glucose meters typically follow an established standard, in this case, a combination of ISO 15197:2015 and FDA guidance.

Acceptance Criteria (FDA Guidance 2016)	Reported Device Performance (On Call Sure Sync BGMS) - User Evaluation Study (All 3 Lots Combined Capillary Blood Samples)	Reported Device Performance (On Call Sure Sync BGMS) - Accuracy at Extreme Glucose Values Study (All 3 Lots Combined Capillary Blood Samples)
For glucose concentrations < 80 mg/dL:	Fingertip: N/A (criteria not specified for fingertip in this range for the user study)	Low Glucose Level (40-80 mg/dL):
>95% of results within ± 15 mg/dL of comparator		100.0% within ± 15 mg/dL (264/264)
>99% of results within ± 20 mg/dL of comparator		100.0% within ± 20 mg/dL (264/264)
For glucose concentrations ≥ 80 mg/dL:		High Glucose Level (250-600 mg/dL):
>95% of results within ± 15% of comparator	Fingertip: 99.5% within ± 15% (364/366) Palm: 98.9% within ± 15% (362/366) Forearm: 98.1% within ± 15% (359/366)	93.4% within ± 10% (171/183) 100.0% within ± 15% (183/183)
>99% of results within ± 20% of comparator	Fingertip: 100.0% within ± 20% (366/366) Palm: 100.0% within ± 20% (366/366) Forearm: 100.0% within ± 20% (366/366)	100.0% within ± 20% (183/183)
Overall Acceptance Criteria: 95% of all SMBG results are within 15% (or 15 mg/dL for <100 mg/dL) of the comparator results across the entire claimed measuring range of the device, and 99% of all SMBG results are within 20% (or 20 mg/dL for <100 mg/dL) of the comparator results across the entire claimed measuring range for the device.	Conclusion: The results of the study passed the acceptance criteria that 95% of all SMBG results are within 15% of the comparator results across the entire claimed measuring range of the device, and that 99% of all SMBG results are within 20% of the comparator results across the entire claimed measuring range for the device.	Conclusion: The results of the study passed the acceptance criteria that 95% of all SMBG results are within 15% of the comparator results across the entire claimed measuring range of the device, and that 99% of all SMBG results are within 20% of the comparator results across the entire claimed measuring range for the device.

Note: The specific percentage of results within ±5% and ±10% are also reported in the document, but the primary acceptance criteria for overall system accuracy are typically based on the ±15% and ±20% thresholds as stated in the FDA guidance.

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

Test Set Sample Size:
- User Evaluation Study: 366 subjects participated. Each subject used 1 lot of test strips (n=122 per lot).
- Accuracy at Extreme Glucose Values Study: 149 capillary blood samples were saved from the user evaluation study participants. This included 88 samples glycolyzed to <80 mg/dL and 61 samples spiked to >250 mg/dL. Each contrived sample was measured in duplicate for each of the 3 lots, resulting in:
  - Low Glucose: 88 samples * 3 lots = 264 measurements
  - High Glucose: 61 samples * 3 lots = 183 measurements
Data Provenance: The studies were conducted as part of a premarket notification (510(k)) submission to the FDA, implying they were performed for regulatory approval purposes. While the specific country of origin for the study participants is not explicitly stated, the submission is from ACON Laboratories, Inc., located in San Diego, California, USA, and follows FDA guidance, suggesting the studies were likely conducted in the United States or under similar clinical regulatory standards. The studies were prospective in nature, involving active recruitment of subjects to use the device.

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

The ground truth reference method used was the YSI Model 2300 STAT PLUS Glucose Analyzer (K913806).
The document states that the YSI 2300 glucose measurement results were obtained by trained technicians. No specific number of experts (technicians) is provided, nor are their detailed qualifications (e.g., years of experience). The YSI 2300 STAT PLUS is a laboratory-grade reference instrument often used for establishing ground truth in glucose monitoring studies.

4. Adjudication Method for the Test Set

For the user evaluation study, the trained technician collected capillary blood samples in microtainer tubes (with heparin anticoagulant) to be measured on the YSI 2300 Stat Plus Glucose Analyzer in duplicate. This duplicate measurement likely served as an internal check for the reference method, but there is no explicit mention of an adjudication method used to resolve discrepancies between device readings and the reference, or between multiple reference measurements, beyond the duplicate testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (Human Readers Improve with AI vs. Without AI Assistance)

This device is a blood glucose monitoring system intended for self-testing by individuals with diabetes. It is a standalone analytical instrument and does not involve "human readers" interpreting medical images or data assisted by AI for diagnosis. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device. The studies focused on the accuracy of the device itself when used by lay persons compared to a laboratory reference.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation (algorithm only, in the sense of the device's internal measurement and calculation) was a core component of the non-clinical testing. This included:
- Precision/Reproducibility: Repeatability and Intermediate Precision studies were conducted using the device on venous blood samples and control solutions.
- Linearity/Assay Reportable Range: Evaluated the device's ability to accurately measure glucose across its claimed range using prepared blood samples.
- Analytical Specificity (Interference): Tested the device's accuracy in the presence of various interfering substances.
- Stability, Detection Limit, Hematocrit Effect, Temperature Effect, Altitude Effect, Sample Volume, Humidity Effect, etc.: These are all tests of the device's inherent analytical performance without direct human interpretation of results beyond performing the test procedure.
The "User Evaluation Study" involved lay persons operating the device, but the focus was on the system accuracy (device + user) compared to the reference, rather than an "algorithm-only" performance in isolation from user impact.

7. The Type of Ground Truth Used

The ground truth used for both the user evaluation study and the accuracy at extreme glucose values study was a laboratory reference method: the YSI Model 2300 STAT PLUS Glucose Analyzer. This is a widely accepted standard for determining glucose concentrations in blood samples.

8. The Sample Size for the Training Set

This document is a 510(k) summary for a traditional blood glucose meter, not an AI/ML-driven device that typically relies on large "training sets" in the same way. The device's measurement principles are based on established electrochemical enzymatic assays. Any internal calibration or algorithm development would likely have been performed using laboratory data during the device's development phase, but specific "training set" sizes are not applicable/provided in the context of this traditional device submission.

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

As noted above, a distinct "training set" in the context of AI/ML is not applicable here. For the device's internal calibration and analytical performance development (if a similar term were to be used), the ground truth for establishing values (e.g., for control solutions) was determined by an in-house procedure using the YSI reference method. The On Call Sure and On Call Sure Sync Blood Glucose Monitoring System is also stated to be traceable to the NIST SRM 917b reference material.

Summary

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Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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.

October 3, 2018

ACON Laboratories, Inc. Qiyi Xie Senior Staff, Regulatory/Clinical Affairs 10125 Mesa Rim Road San Diego, CA 92121

Re: K181527

Trade/Device Name: On Call Sure Blood Glucose Monitoring System On Call Sure Sync Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: August 30, 2018 Received: August 31, 2018

Dear Qiyi Xie:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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

Courtney H. Lias, Ph.D. for 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) K181527

Device Name

On Call Sure Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable):
--------------------------------------------------

For activities identified in 33 CFR 151.207, including lightering	In areas other than those identified in 33 CFR 151.207, including lightering
--------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K181527

Device Name

On Call Sure Sync Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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5. 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is K181527.

Submitter's Identification:

ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121

Tel.: 858-875-8011 Fax: 858-875-8019

Date Prepared: October 1, 2018

Contact Person:

Qiyi Xie Senior Officer, Clinical & Regulatory Affairs Email: qxie@aconlabs.com

Proprietary Name of the Device:

On Call Sure Blood Glucose Monitoring System On Call Sure Sync Blood Glucose Monitoring System

Common Name:

Glucose Test System

Classification Name:

Class II §862.1345 Glucose Test System

Predicate Device:

On Call Sharp Blood Glucose Monitoring System

ACON Laboratories, Inc. 10125 Mesa Rim Rd, San Diego, CA 92121

510(k) Number: K130284

Device Name: On Call Sure Blood Glucose Monitoring System On Call Sure Sync Blood Glucose Monitoring System

Proprietary Name	Classification	ProductCode	Description	Common Name
On Call Sure andOn Call Sure SyncBlood GlucoseMonitoring System	862.1345 Class II	NBW	System, Test,Blood Glucose,Over the Counter	Glucose TestSystem

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Device Description:

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Intended Use:

On Call Sure Blood Glucose Monitoring System

The On Call Sure Blood Glucose Monitoring System is comprised of the On Call Sure Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Blood Glucose Monitoring System is intended for single-patient use and should not be shared.

On Call Sure Sync Blood Glucose Monitoring System

The On Call Sure Sync Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Sync Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. Alternative site testing should be done only during steadystate times (when glucose is not changing rapidly).

On Call Sure Test Strips

On Call Sure Test Strips are used with the On Call Sure Sync Blood Glucose Meters in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

On Call Sure Sync Glucose Control Solutions

On Call Sure Glucose Control Solutions are for use with the On Call Sure and On Call Sure Sync Blood Glucose Meters and Strips as a quality control check to confirm that the test strip and meter are working together properly, and that the user can perform the test correctly.

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Technological Characteristics:

	On Call Sure	On Call Sure Sync
System	Blood Glucose Meter	Blood Glucose Meter
Measurement Range	40-600 mg/dL	Same
Test Time	5 second	Same
Minimum Sample Size	0.6 uL	Same
Coding	Auto Coding	Same
Hematocrit Range	10-70%	Same
Insufficient Sample	Error message	Same
Control Recognition	Yes	Same
Strip Open Vial Stability	6 months from first opening	Same
Strip Closed Vial Stability	24 months (from DOM)	Same
Strip Storage Temperature	2°C - 35°C (36° - 95 °F)	Same
Strip Storage RelativeHumidity	10-90% R.H.	Same
Operating Temperature	5°C - 45°C (41° - 113 °F)	Same
Operating Relative Humidity	10-90% R.H.	Same
Precision	<5% CV	Same
Accuracy	Within +/-15% (95% data pts)	Same
Sample - Fresh capillarywhole blood	Yes	Same
AST - Palm	Yes	Same
AST - Forearm	Yes	Same
Meter Memory	Up to 1000 records with time anddate	Same
Day Average	7, 14, 30, 60 and 90-day averages	Same
Hypo & Hyper Indicator	Yes	Same
Test Reminder	Yes	Same
Meal Marker	Yes	Same
Meter Auto Power Off	2 minutes after last action	Same
Meter Audio	Yes	Same
Battery Type	Two (2) CR 2032 3.0V coin cellbatteries	Same
Battery Life	3,000 glucose tests	3,000 glucose tests (notconsidering Bluetooth datatransfer)
Strip Ejector	Yes	Same
Wireless Frequency(On Call Sure Sync Meter)	Not applicable	2.4 GHz worldwide ISMband(Instrumentation,Scientific and Medical);Bluetooth 4.2 Low Energy

Specifications of the On Call Sure and On Call Sure Sync Blood Glucose Meters:

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Special conditions for use statement(s):

For in vitro diagnostic use only
For single patient use only; should not be shared .
Not intended for use on neonates
Not for diagnosis of or screening for diabetes mellitus
Not to be used for patients who are dehydrated, hypotensive, in shock, critically ill or in a ● hyperosmolar state
. Alternate site testing (AST) should not be used to calibrate continuous glucose monitors (CGMs) nor for use in insulin dose calculations
AST should only be done during steady-state times (when glucose is not changing rapidly) ●
System should only be used with single patient use lancing device with sterile lancets.

Special instrument requirements:

The On Call Sure and On Call Sure Sync Blood Glucose Meter

Single patient use lancing device with sterile lancets should be used with the On Call Sure and On . Call Sure Sync Blood Glucose Monitoring System.
Proper cleaning of the meter with qualified cleaning wipes is required.

Substantial Equivalence:

Predicate Device:

On Call Sharp Blood Glucose Monitoring System

ACON Laboratories Inc 10125 Mesa Rim Rd, San Diego, CA 92121

510(k) Number: K130284

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Comparison with predicate:

Feature	On Call Sure / On Call Sure SyncBlood Glucose Monitoring System	On Call Sharp Blood GlucoseMonitoring System (K132084)
Indications for Use	The On Call Sure and On Call SureSync Blood Glucose MonitoringSystems are comprised of the On CallSure or On Call Sure Sync BloodGlucose Meter and On Call Sure BloodGlucose Test Strips. The On Call Sureand On Call Sure Sync Blood GlucoseMonitoring Systems are intended to beused for the quantitative measurementof glucose in fresh capillary wholeblood from the fingertips, forearm andpalm. The On Call Sure and On CallSure Sync Blood Glucose MonitoringSystems are intended for self-testingby people with diabetes at home as anaid to monitoring the effectiveness ofdiabetes control programs. The OnCall Sure and On Call Sure SyncBlood Glucose Monitoring Systemsare intended for single-patient use andshould not be shared.The On Call Sure and On Call SureSync Blood Glucose MonitoringSystems are for in vitro diagnostic use.The On Call Sure and On Call SureSync Blood Glucose MonitoringSystems are not intended for thediagnosis of or screening for diabetes,nor intended for use on neonates.Alternative site testing should be doneonly during steady-state times (whenglucose is not changing rapidly).	The On Call Sharp Blood GlucoseMonitoring System is anelectrochemical enzymatic assay forthe quantitative detection of glucosein fresh capillary whole blood fromthe fingertip, forearm, and palm bypeople with diabetes at home as anaid in monitoring the effectiveness ofdiabetes control programs. Forearmand palm testing sites should be usedalternately only when blood glucoselevel is not changing rapidly. The OnCall Sharp Blood GlucoseMonitoring System is intended to beused by a single patient and shouldnot be shared. It is for in vitrodiagnostic use only.
Detection Method	Amperometric electrochemical	Same
Enzyme	Glucose Dehydrogenase (FAD-GDH)	Same
Calibration Coding	Auto-coding	Non-coding
Test Range	40 - 600 mg/dL	20 - 600 mg/dL
Memory	1000 records with time and date	500 records with time and date
Sample Type	Capillary whole blood	Same
Sample Sites	Fingertip, forearm, palm	Same
Sample Volume	0.6 µL	0.8 µL
Sample Test Time	5 seconds	Same
Hematocrit Range	10 - 70%	25 - 70%
Altitude Study	Up to 10000 feet	Up to 8516 feet
Glucose Units ofMeasure	mg/dL	Same
Feature	On Call Sure / On Call Sure SyncBlood Glucose Monitoring System	On Call Sharp Blood GlucoseMonitoring System (K132084)
OperatingTemperature	41-113°F (5-45°C)	50-113°F (10-45°C)
Operating RelativeHumidity	10-90%	Same
Data Port	Serial data port	Same
Automatic Shutoff	Two minutes after last user action	Same
Power Source	Two CR 2032 3.0V coin cell batteries	Same
Meter Size	90 x 60 x 16 mm	90 x 58 x 22 mm
Meter Weight	Approx. 72 g (with batteries installed)	Approx. 50 g (with battery installed)
Battery Life	Minimum of 3,000 measurements(without considering data transfer andtest reminder alarms)	Minimum of 1,000 measurements(without considering data transferand test reminder alarms)

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Non-Clinical Tests Performed for Determination of Substantial Equivalence

Standard/Guidance Documents Referenced:

. FDA Guidance for Industry and Food and Drug Administration Staff - Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
. Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using ● Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices ●
General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January ● 2002
CLSI/NCCLS EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
CLSI/NCCLS EP07-A2: Interference Testing in Clinical Chemistry: Approved Guideline ● Second Edition
EN ISO 13485:2012/AC:2012: Medical devices Quality management systems Requirements . for regulatory purposes
EN 13532:2002: General requirements for in vitro diagnostic medical devices for self-testing
EN 13612:2002/AC:2002: Performance evaluation of in vitro diagnostic medical devices ●
EN 13640:2002/EN 13640:2002: Stability testing of in vitro diagnostic reagents ●
EN 13641:2002: Elimination or reduction of risk of infection related to in vitro diagnostic ● reagents
EN ISO 14971:2012: Medical devices - Application of Risk management to medical devices
EN ISO 15197:2015: In vitro diagnostic test systems Requirements for blood-glucose ● monitoring systems for self-testing in managing diabetes mellitus
. EN ISO 15223-1:2016: Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2016-12-15)
. EN ISO 17511:2003: In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials

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. EN ISO 18113-1:2011: In vitro diagnostic medical devices. Information supplied by the manufacturer (labeling). Part 1: Terms, definitions and general requirements
. EN ISO 18113-2:2011: In vitro diagnostic medical devices. Information supplied by the manufacturer (labeling). Part 2: In vitro diagnostic reagents for professional use
EN ISO 18113-3:2011: In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3: In vitro diagnostic instruments for professional use
EN ISO 18113-4:2011: In vitro diagnostic medical devices. Information supplied by the manufacturer (labeling). Part 4: In vitro diagnostic reagents for self-testing
. EN ISO 18113-5:2011: In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 5: In vitro diagnostic instruments for self-testing
. EN 13640:2002: Stability testing of in vitro diagnostic reagents
. IEC 60068-2-64:2008: Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
. IEC/EN 61010-1:2010: Safety requirements for electrical equipment for measurement, control and laboratory use. General requirements
. IEC 61010-2-101:2015: Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 60601-1-2:2014: International Standard: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
EN 62366:2008: Medical devices. Application of usability engineering to medical devices
EN 62304:2006 / AC:2008: Medical device software. Software life-cycle processes ●
. ASTM D 4169-09A: Standard Practice for Performance Testing of Shipping Containers and Systems
Council Directive 2002/95/EC: on Waste Electrical and Electronic Equipment (WEEE . Directive)
. Council Directive 80/181/EEC of 20 December 1979: EU Metric Directive
Council Directive 1999/103/EC: amending council directive 80/181/ECC on the approximation . of the laws of Member States relating to units of measurement
. Directive 2011/65/EU: on the restriction of the use of certain hazardous substances in electrical and electronic equipment
. EN 50581:2012: Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
. IEC 62321:2008: Electrotechnical products - Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers)

Laboratory Performance Testing:

The performance characteristics of the On Call Sure and On Call Sure Sync Blood Glucose Monitoring System were evaluated in the following studies: repeatability precision, intermediate precision, linearity, interfering agents, hematocrit effect, temperature effect evaluation - blood & control solution, low battery effect, altitude effect, sample volume, humidity effect, simulated shipping study - test strip & control solution, control value assignment, meter testing, software validation testing, electromagnetic compatibility and electrical safety testing as part of meter and strip validation testing.

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a. Precision/Reproducibility

Repeatability Precision

Ten replicate assays were each run on ten On Call Sure Sync Blood Glucose Meters. Heparinized venous blood samples at six concentration levels were used in the testing. The results provided the following estimates for reproducibility, and precision.

MEAN	42.6 mg/dL	82.2 mg/dL	133.3mg/dL	205.1mg/dL	334.6 mg/dL	517.6 mg/dL
Standard Deviationmg/dL orCoefficient ofVariation (CV)	1.24 mg/dL	2.28 mg/dL	2.5 %	2.5 %	2.6 %	2.2 %

Intermediate Precision

Ten replicate assays drawn from three strip lots were run on ten On Call Sure Sync Blood Glucose Meters. These tests were run each day for a total of ten days. Control solutions at six concentration levels were used in the testing. The results provided the following estimates.

#	MEAN	Standard Deviation (mg/dL) orCoefficient of Variation (CV)
Strip Lot 1	36.0 mg/dL	0.91 mg/dL
	67.7 mg/dL	1.50 mg/dL
	128.1 mg/dL	2.3 %
	167.5 mg/dL	1.9 %
	321.0 mg/dL	2.1 %
	432.2 mg/dL	2.3 %
Strip Lot 2	35.8 mg/dL	1.09 mg/dL
	67.6 mg/dL	1.77 mg/dL
	127.8 mg/dL	2.7 %
	167.8 mg/dL	2.5 %
	320.9 mg/dL	2.0 %
	426.5 mg/dL	1.9 %
Strip Lot 3	36.0 mg/dL	1.05 mg/dL
	67.6 mg/dL	1.57 mg/dL
	127.5 mg/dL	2.7 %
	168.4 mg/dL	2.2 %
	319.9 mg/dL	1.6 %
	420.7 mg/dL	1.8 %

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b) Linearity/assay reportable range:

Linearity was evaluated using 3 lots of test strips, 10 meters, and prepare blood sample to 42%+2% hematocrit level checked by Hematocrit Reader. Prepare eleven blood glucose concentration levels as shown in Table 1. The glucose concentration in venous blood samples may be adjusted by supplementing the sample with an around 20% aqueous glucose solution. (The aqueous glucose solution for blood sample glucose spiking shall be allowed to stand for at least 2 hours before use to allow for complete mutarotation and equilibration of the D and L enantiomers.) Each blood glucose concentration is tested by YSI Glucose Analyzer as shown in the following table:

Level	Glucose Concentration Level (mg/dL)Plasma YSI Value
10	5-20 mg/dL
25	20 -30 mg/dL
50	40 - 60 mg/dL
80	70 - 90 mg/dL
110	100 -120 mg/dL
170	160 -180 mg/dL
220	210 - 230 mg/dL
330	310 - 350 mg/dL
450	430 - 470 mg/dL
550	520 - 580 mg/dL
650	600 - 700 mg/dL

Linear regression analysis for each test strip lot compared to the YSI:

y = 1.0055x + 0.3755; R2 = 0.9976 for Test Strip Lot 1

y = 1.0023x - 0.3007; R2 = 0.9976 for Test Strip Lot 2

y = 0.9948x + 0.4345; R2 = 0.9991 for Test Strip Lot 3

The linear range of the On Call Sure and On Call Sure Sync Blood Glucose Monitoring System is 10-600 mg/dL.

c) Traceability, Stability, Expected values (controls, calibrators, or methods):

The On Call Sure and On Call Sure Sync Blood Glucose Monitoring System is traceable to the NIST SRM 917b reference material. The method comparison study was performed using the candidate device and YSI as the reference method.

Value assignment:

The value assignment of the On Call Sure and On Call Sure Sync Blood Glucose control solutions were determined by an in-house procedure. 2 levels of control solutions (Levels 1 and 2) were prepared by gravimetric addition of glucose to achieve target glucose values and were confirmed by the YSI reference method. Verification of the control solutions was done by testing with 80 test strips and at least 2 meters with each level, and the values were within the target ranges.

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d) Stability:

Accelerated stability studies were conducted to assess the shelf-life and open vial stability of the control solutions and test strips with on-going real-time stability study. Unopened control solutions have a 24 month shelf life and are stable for 6 months after first opening when stored at 36-95°F (2-35°C ) and 10 -90% relative humidity. The unopened test strips have a 24 month shelf life and are stable for 6 months after first opening when stored in a cool, dry place between 36-95°F (2-35°C) and 10-90% relative humidity and kept out of direct sunlight.

e) Detection limit:

The reportable range is 40-600 mg/dL based on clinical study lab testing results.

f) Analytical specificity:

To assess potential interference, the sponsor used venous whole blood samples adjusted to three glucose concentration intervals of 50-70 mg/dL, 110 - 130 mg/dL and 250-270 mg/dL. Blood samples were adjusted to a hematocrit level of 42%±2% and checked by a hematocrit reader. The interfering substance samples of both the Test Pool and Control Pool were prepared with the respective substance concentrations in the following table. Test Pool samples were prepared to the specified concentrations. Control Pool samples were prepared with the same solvent without the substance. Results are shown below:

InterferingSubstance	Therapeutic /PhysiologicalLevel	Test Concentration		On Call Sure andOn Call Sure SyncSystems
		Low	High
Acetaminophen	1.0-3.0 mg/dL	4 mg/dL	20 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Ascorbic Acid	0.4-2.0 mg/dL	3 mg/dL	6 mg/dL	NO INTERFERENCE attherapeutic levels andlevels ≤ 3.0 mg/dL*
Cholesterol	114-300 mg/dL	250 mg/dL	500 mg/dL	NO INTERFERENCE atphysiological levels up tohigh test concentration
Conjugated-Bilirubin	<0.4 mg/dL	34 mg/dL	50 mg/dL	NO INTERFERENCE atphysiological levels up tohigh test concentration
Creatinine	0.6-1.3 mg/dL	1.5 mg/dL	10 mg/dL	NO INTERFERENCE atphysiological levels up tohigh test concentration
InterferingSubstance	Therapeutic /PhysiologicalLevel	Test Concentration		On Call Sure andOn Call Sure SyncSystems
Dopamine	0.03 mg/dL	0.03 mg/dL	20 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
EDTA	180 mg/dL	100 mg/dL	200 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Ephedrine	0.001 mg/dL	0.1 mg/dL	0.5 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Ethanol	100-200 mg/dL	200 mg/dL	400 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Fructose	1-6 mg/dL	30 mg/dL	100 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Galatitol		0.03 mg/dL	0.09 mg/dL	NO INTERFERENCE atlevels up to high testconcentration
Galactose	4-80 mg/dL	78 mg/dL	100 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Gentisic acid	0.2-0.6 mg/dL	10 mg/dL	100 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Glutathione(Reduced)	47-100 mg/dL(Intracellular)	0.1 mg/dL	92 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Hemoglobin	100-200 mg/dL	200 mg/dL	2000 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
HeparinSodium	350-1000 u/L	3000 u/L	80000 u/L	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Ibuprofen	1.0-7.0 mg/dL	7 mg/dL	50 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Isomalt		0.03 mg/dL	0.09 mg/dL	NO INTERFERENCE atlevels up to high testconcentration
Lactitol		0.03 mg/dL	0.09 mg/dL	NO INTERFERENCE atlevels up to high testconcentration
InterferingSubstance	Therapeutic /PhysiologicalLevel	Test Concentration		On Call Sure andOn Call Sure SyncSystems
		Low	High
Lactose	0.5 mg/dL	5 mg/dL	25 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
L-Dopa(Levo-Dopa)	0.02-0.3 mg/dL	0.3 mg/dL	3 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Maltitol		0.03 mg/dL	0.09 mg/dL	NO INTERFERENCE atlevels up to high testconcentration
Maltose	100 mg/dL	40 mg/dL	10000 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Mannitol	0.0128 mg/dL	300 mg/dL	600 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Methyl Dopa	0.1-0.75 mg/dL	0.75 mg/dL	1000 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
ParalidoximeIdodine (PAM)		25 mg/dL	80 mg/dL	NO INTERFERENCE atlevels up to high testconcentration
Salicylic Acid	10-30 mg/dL	30 mg/dL	60 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Sodium			414 mg/dL	NO INTERFERENCE atlevels up to high testconcentration
Sorbitol	0.044mg/dL	30 mg/dL	70 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Tetracycline	0.2-0.5 mg/dL	0.5 mg/dL	1.5 mg/dL	NO INTERFERENCE atphysiological levels up tohigh test concentration
Tolazamide	2.0-2.5 mg/dL	5 mg/dL	40 mg/dL	NO INTERFERENCE atphysiological levels up tohigh test concentration
Tolbutamide	5.4-10.8 mg/dL	11 mg/dL	100 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Triglycerides	150-500 mg/dL	1500 mg/dL	3000 mg/dL	NO INTERFERENCE atphysiological levels up tohigh test concentration
InterferingSubstance	Therapeutic /PhysiologicalLevel	Test Concentration		On Call Sure andOn Call Sure SyncSystems
		Low	High
Unconjugated-Bilirubin	0.3-1.3 mg/dL	20 mg/dL	40 mg/dL	NO INTERFERENCE atphysiological levels up tohigh test concentration
Urea	6.6-85.8 mg/dL	260 mg/dL	600 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Uric Acid	2.5-8.0 mg/dL	8 mg/dL	24 mg/dL	NO INTERFERENCE attherapeutic levels up tohigh test concentration
Xylitol		0.03 mg/dL	0.09 mg/dL	NO INTERFERENCE atlevels up to high testconcentration
Xylose	20-40 mg/dL	1 mg/dL	200 mg/dL	INTERFERENCE at levelsof 90 mg/dL and 200mg/dL;NO INTERFERENCE atlevels < 6 mg/dL**

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Ascorbic Acid precaution (labeling) is needed based on FDA guidance and CLSI guidance differences.

**The results showed no significant interference on the OC Sure Sync Blood Glucose Monitoring System when Xylose was ≤6 mg/dL.

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Discussion of Clinical Tests Performed:

The clinical study protocol followed "FDA Guidance for Industry and Food and Drug Administration Staff- Self--Monitoring Blood Glucose Test Systems for Over-the-Counter Use (2016)." The clinical studies were conducted with lay persons using the On Call Sure Sync Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On Call Sure Sync Blood Glucose Monitoring System compared to the YSI Model 2300 STAT PLUS (K913806) per the ACON Clinical Study Protocol for the Blood Glucose Monitoring System. Study results indicate that non-professional, inexperienced lay persons were able to obtain comparable blood glucose readings when using the On Call Sure Sync Blood Glucose Monitoring System as compared to the YSI 2300 glucose measurement results obtained by the trained technicians. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use in the User's Manual and the overall performance of the On Call Sure Sync Blood Glucose Monitoring System.

Method comparison with device:

Part I: User Evaluation Study

Based on "FDA Guidance for Industry and Food and Drug Administration Staff-Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (2016)," study participants were recruited to assess the system accuracy by measuring the blood glucose levels of finger, palm, and forearm capillary blood samples both on their own using the On Call Sure Sync Blood Glucose Monitoring System and 3 lots of test strips..

366 subjects participated in the study with 3 lots of strips (n=122/lot), including 38 subjects who indicated in the Case Report Form that they were naive users of blood glucose monitoring systems.

Each study subject was sequestered in an air-conditioned room with a window, furnished with a table and chairs, to simulate an OTC intended use environment. Each subject was given 1 lot of test strips, obtained and tested his/her own capillary blood sample to perform the blood glucose measurement on the studied system according to the manual reading understanding. The trained technician collected capillary blood samples in microtainer tubes (with heparin anticoagulant) to be measured on the YSI 2300 Stat Plus Glucose Analyzer in duplicate.

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Additionally, capillary blood samples were collected for the accuracy at extreme glucose values study. In this study, collected capillary blood samples are either glycolyzed or spiked with additional glucose for both YSI reference measurement and meter measurement.

Results relative to YSI:

Tested Glucose Concentration Range:

In the user evaluation study, reference glucose concentrations measured from YSI 2300 Stat Plus ranged from 53.8 to 537.5 mg/dL. 21 unaltered capillary samples were collected with glucose concentration <80 mg/dL, and 48 unaltered capillary samples were collected with glucose concentration >250 mg/dL. The subject blood hematocrit range was 26-58%.

Fingertip:

Strip Lot		Slope	Intercept	R	R²	N
1790001	Linear Regression	0.9988	-0.6583	0.9917	0.9836	122
	Lower 99% Confidence Interval	0.9680	-6.0381
	Upper 99% Confidence Interval	1.0297	4.7214
Strip Lot		Slope	Intercept	R	R²	N
1790002	Linear Regression	1.0155	-3.1305	0.9914	0.9828	122
	Lower 99% Confidence Interval	0.9834	-9.0532
	Upper 99% Confidence Interval	1.0475	2.7923
Strip Lot		Slope	Intercept	R	R²	N
1790003	Linear Regression	1.0245	-5.2398	0.9917	0.9834	122
	Lower 99% Confidence Interval	0.9927	-10.5395
	Upper 99% Confidence Interval	1.0563	0.0600
Strip Lot	All 3 Lots Linear Regression	Slope	Intercept	R	R²	N
All 3 Lots	Linear Regression	1.0132	-3.0677	0.9915	0.9831	366
	Lower 99% Confidence Interval	0.9952	-6.2246
	Upper 99% Confidence Interval	1.0312	0.0893

Summary of Linear Regression - Fingertip Site Measurement by Lay Users

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Summary of User Evaluation System Accuracy in Tabular Format – Fingertip Site Measurement by Lay Users

Finger Site
Lot 1790001
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
67 / 122 ( 54.9% )	109 / 122 ( 89.3% )	122 / 122 ( 100.0% )	122 / 122 ( 100.0% )

Finger Site
Lot 1790002
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
68 / 122 ( 55.7% )	109 / 122 ( 89.3% )	121 / 122 ( 99.2% )	122 / 122 ( 100.0% )

Finger Site
Lot 1790003
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
66 / 122 ( 54.1%)	107 / 122 ( 87.7%)	121 / 122 ( 99.2%)	122 / 122 ( 100.0%)

Finger Site
All 3 Lots Combined
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
201 / 366 ( 54.9% )	325 / 366 ( 88.8% )	364 / 366 ( 99.5% )	366 / 366 ( 100.0% )

Summary of Linear Regression – Palm Site Measurement by Lay Users

Strip Lot		Slope	Intercept	R	R2	N
1790001	Linear Regression	1.0003	-1.7710	0.9867	0.9735	122
	Lower 99% Confidence Interval	0.9609	-8.6405
	Upper 99% Confidence Interval	1.0397	5.0984
1790002	Linear Regression	0.9722	1.1633	0.9907	0.9816	122
	Lower 99% Confidence Interval	0.9404	-4.7125
	Upper 99% Confidence Interval	1.0040	7.0392
1790003	Linear Regression	0.9883	-1.6537	0.9890	0.9781	122
	Lower 99% Confidence Interval	0.9530	-7.5432
	Upper 99% Confidence Interval	1.0237	4.2358
All 3 Lots	Linear Regression	0.9851	-0.4936	0.9889	0.9780	366
	Lower 99% Confidence Interval	0.9650	-4.0130
	Upper 99% Confidence Interval	1.0052	3.0259

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Palm Site
Lot 1790001
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
63 / 122 ( 51.6% )	104 / 122 ( 85.2% )	121 / 122 ( 99.2% )	122 / 122 ( 100.0% )

Summary of System Accuracy in Tabular Format – Palm Site Measurement by Lay Users

Palm Site
Lot 1790002
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
63 / 122 ( 51.6%)	103 / 122 ( 84.4%)	121 / 122 ( 99.2%)	122 / 122 ( 100.0%)
Palm Site
Lot 1790003
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
62 / 122 ( 50.8% )	102 / 122 ( 83.6% )	120 / 122 ( 98.4% )	122 / 122 ( 100.0% )

Palm Site
All 3 Lots Combined
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
188 / 366 ( 51.4% )	309 / 366 ( 84.4% )	362 / 366 ( 98.9% )	366 / 366 ( 100.0% )

Summary of Linear Regression – Forearm Site Measurement by Lay Users

Strip Lot		Slope	Intercept	R	R²	N
1790001	Linear Regression	1.0086	-0.3791	0.9889	0.9779	122
	Lower 99% Confidence Interval	0.9724	-6.6891
	Upper 99% Confidence Interval	1.0448	5.9308
1790002	Linear Regression	0.9822	3.5869	0.9895	0.9791	122
	Lower 99% Confidence Interval	0.9480	-2.7368
	Upper 99% Confidence Interval	1.0165	9.9106
1790003	Linear Regression	0.9993	1.2168	0.9863	0.9728	122
	Lower 99% Confidence Interval	0.9593	-5.4384
	Upper 99% Confidence Interval	1.0392	7.8721
All 3 Lots	Linear Regression	0.9946	1.7728	0.9884	0.9770	366
	Lower 99% Confidence Interval	0.9739	-1.8616
	Upper 99% Confidence Interval	1.0154	5.4071

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Summary of User Evaluation System Accuracy in Tabular Format - Forearm Site Measurement by Lav Users

Forearm Site
Lot 1790001
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
61 / 122 ( 50.0%)	101 / 122 ( 82.8%)	120 / 122 ( 98.4%)	122 / 122 (100.0%)
Forearm Site
Lot 1790002
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
59 / 122 (48.4%)	100 / 122 ( 82.0%)	119 / 122 (97.5%)	122 / 122 ( 100.0%)
Forearm Site
Lot 1790003

ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
Lot 1790003
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
	60 / 122 ( 49.2% ) 102 / 122 ( 83.6% ) 20 / 122 ( 98.4% ) 22 / 122 ( 100.0% )
Forearm Site
All 3 Lots Combined
Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
180 / 366 ( 49.2% )	303 / 366 ( 82.8% )	359 / 366 ( 98.1% )	366 / 366 ( 100.0% )

Part I Conclusion (User Evaluation Study)

The results of the study passed the acceptance criteria that 95% of all SMBG results are within 15% of the comparator results across the entire claimed measuring range of the device, and that 99% of all SMBG results are within 20% of the comparator results across the entire claimed measuring range for the device.

Part II:

Accuracy at Extreme Glucose Values Study

Based on "FDA Guidance for Industry and Food and Drug Administration Staff-Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (2016)," the accuracy at the extreme upper and lower ends of the claimed measuring range were assessed using capillary blood samples obtained from subjects in the user evaluation study. Capillary blood samples (n=149) were saved and used for the accuracy at extreme glucose values study. 88 capillary blood samples were glycolyzed at room temperature to obtain glucose concentrations <80 mg/dL, and 61 capillary blood samples were spiked with glucose solution to obtain glucose concentrations >250 mg/dL. Each contrived blood sample was measured with the SMBG in duplicate for each lot.

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Results relative to YSI:

Summary of Accuracy at Extreme Glucose Values Study - Tabular Data Format

Low Glucose Level: 40 - 80 mg/dL, First Measurement Only Accuracy at Extreme Glucose Value by Absolute Bias - Low

On Call Sure/On Call Sure Sync BGMS - Accuracy at Extreme Glucose Values
Glucose concentrations ≤ 80 mg/dL
Lot	Within ± 5 mg/dL	Within ± 10 mg/dL	Within ± 15 mg/dL	Within ± 20 mg/dL
1790001	63 / 88 ( 71.6% )	88 / 88 ( 100.0% )	88 / 88 ( 100.0% )	88 / 88 ( 100.0% )
1790002	70 / 88 ( 79.5% )	88 / 88 ( 100.0% )	88 / 88 ( 100.0% )	88 / 88 ( 100.0% )
1790003	66 / 88 ( 75.0% )	88 / 88 ( 100.0% )	88 / 88 ( 100.0% )	88 / 88 ( 100.0% )
All 3 Lots	199 / 264 ( 75.4% )	264 / 264 ( 100.0% )	264 / 264 ( 100.0% )	264 / 264 ( 100.0% )

High Glucose Level: 250 - 600 mg/dL, First Measurement Only Accuracy at Extreme Glucose Value by % Bias - High

On Call Sure/On Call Sure Sync BGMS - Accuracy at Extreme Glucose Values
Glucose concentrations ≥ 250 mg/dL
Lot	Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
1790001	43 / 61 ( 70.5% )	58 / 61 ( 95.1% )	61 / 61 ( 100.0% )	61 / 61 ( 100.0% )
1790002	40 / 61 ( 65.6% )	55 / 61 ( 90.2% )	61 / 61 ( 100.0% )	61 / 61 ( 100.0% )
1790003	41 / 61 ( 67.2% )	58 / 61 ( 95.1% )	61 / 61 ( 100.0% )	61 / 61 ( 100.0% )
All 3 Lots	124 / 183 ( 67.8% )	171 / 183 ( 93.4% )	183 / 183 ( 100.0% )	183 / 183 ( 100.0% )

Part II Conclusion (Accuracy at Extreme Glucose Values Study)

The results of the study passed the acceptance criteria that 95% of all SMBG results are within 15% of the comparator results across the entire claimed measuring range of the device, and that 99% of all SMBG results are with 20% of the comparator results across the entire claimed measuring range for the device.

Overall Conclusions:

The results of the study demonstrated that the On Call Sure Sync Blood Glucose Monitoring System is accurate in the claimed measuring range using finger capillary blood samples obtained from subjects, based upon both the user evaluation and the extreme glucose values study.

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.