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

K181527 · ACON Laboratories, Inc. · NBW · Oct 3, 2018 · Clinical Chemistry

Device Facts

• Record ID: K181527
• Device Name: On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
• Applicant: ACON Laboratories, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

System measures glucose in fresh capillary whole blood (fingertip, forearm, palm) using amperometric electrochemical detection. Test strips contain glucose dehydrogenase (FAD-GDH) and a mediator; reaction produces electrical current proportional to glucose concentration. Meters are auto-coding; display results calibrated to plasma reference. On Call Sure Sync model includes Bluetooth 4.2 Low Energy module for wireless data transfer to mobile devices; both models include inactive USB port. Used by patients at home for self-monitoring; single-patient use only. Healthcare providers use results to assess diabetes control program effectiveness. Benefits include convenient, rapid (5-second) glucose monitoring to support glycemic management.

Clinical Evidence

User evaluation study (n=366) compared patient-obtained capillary results (fingertip, palm, forearm) against YSI 2300 STAT PLUS. Results showed 100% of fingertip samples within ±20% of reference for all concentrations. Extreme glucose study (n=149) confirmed performance at <80 mg/dL and >250 mg/dL ranges. Bench testing validated hematocrit (10-70%), altitude (up to 10,000 ft), and environmental robustness.

Technological Characteristics

Amperometric electrochemical glucose test system. Uses FAD-GDH enzyme. Auto-coding. Measurement range 40-600 mg/dL. Sample volume 0.6 µL. Test time 5 seconds. Connectivity: Bluetooth 4.2 LE (Sync model), USB (inactive). Power: 2x CR2032 3.0V batteries. Hematocrit range 10-70%.

Indications for Use

Indicated for self-testing by people with diabetes at home to monitor glucose levels in fresh capillary whole blood (fingertip, forearm, palm) as an aid in diabetes control programs. Not for neonates, diabetes diagnosis, or screening. Not for patients who are dehydrated, hypotensive, in shock, critically ill, or in a hyperosmolar state.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• On Call Sharp Blood Glucose Monitoring System (k130284)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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).

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

| <span> <input type="checkbox"/> For activities identified in 33 CFR 151.207, including lightering </span> | <span> <input checked="checked" type="checkbox"/> In areas other than those identified in 33 CFR 151.207, including lightering </span> |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|

| | 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:

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"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)

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).

| 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.*

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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## 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.: [phone] Fax: [phone]

Date Prepared: October 1, 2018

## Contact Person:

Qiyi Xie Senior Officer, Clinical & Regulatory Affairs Email: [e-mail]

## 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 | Product<br>Code | Description | Common Name |
|-------------------------------------------------------------------------------------------|-------------------|-----------------|-----------------------------------------------------|------------------------|
| <i>On Call Sure</i> and<br><i>On Call Sure Sync</i><br>Blood Glucose<br>Monitoring System | 862.1345 Class II | NBW | System, Test,<br>Blood Glucose,<br>Over the Counter | Glucose Test<br>System |

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#### 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.

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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.

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).

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

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 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 Relative<br>Humidity | 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 capillary<br>whole blood | Yes | Same |
| AST - Palm | Yes | Same |
| AST - Forearm | Yes | Same |
| Meter Memory | Up to 1000 records with time and<br>date | 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 cell<br>batteries | Same |
| Battery Life | 3,000 glucose tests | 3,000 glucose tests (not<br>considering Bluetooth data<br>transfer) |
| Strip Ejector | Yes | Same |
| Wireless Frequency<br>(On Call Sure Sync Meter) | Not applicable | 2.4 GHz worldwide ISM<br>band(Instrumentation,<br>Scientific and Medical);<br>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 Sync<br>Blood Glucose Monitoring System | On Call Sharp Blood Glucose<br>Monitoring System (K132084) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The On Call Sure and On Call Sure<br>Sync Blood Glucose Monitoring<br>Systems are comprised of the On Call<br>Sure or On Call Sure Sync Blood<br>Glucose Meter and On Call Sure Blood<br>Glucose Test Strips. The On Call Sure<br>and On Call Sure Sync Blood Glucose<br>Monitoring Systems are intended to be<br>used for the quantitative measurement<br>of glucose in fresh capillary whole<br>blood from the fingertips, forearm and<br>palm. The On Call Sure and On Call<br>Sure Sync Blood Glucose Monitoring<br>Systems are intended for self-testing<br>by people with diabetes at home as an<br>aid to monitoring the effectiveness of<br>diabetes control programs. The On<br>Call Sure and On Call Sure Sync<br>Blood Glucose Monitoring Systems<br>are intended for single-patient use and<br>should not be shared.<br><br>The On Call Sure and On Call Sure<br>Sync Blood Glucose Monitoring<br>Systems are for in vitro diagnostic use.<br>The On Call Sure and On Call Sure<br>Sync Blood Glucose Monitoring<br>Systems are not intended for the<br>diagnosis of or screening for diabetes,<br>nor intended for use on neonates.<br>Alternative site testing should be done<br>only during steady-state times (when<br>glucose is not changing rapidly). | The On Call Sharp Blood Glucose<br>Monitoring System is an<br>electrochemical enzymatic assay for<br>the quantitative detection of glucose<br>in fresh capillary whole blood from<br>the fingertip, forearm, and palm by<br>people with diabetes at home as an<br>aid in monitoring the effectiveness of<br>diabetes control programs. Forearm<br>and palm testing sites should be used<br>alternately only when blood glucose<br>level is not changing rapidly. The On<br>Call Sharp Blood Glucose<br>Monitoring System is intended to be<br>used by a single patient and should<br>not be shared. It is for in vitro<br>diagnostic 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 of<br>Measure | mg/dL | Same |
| Feature | On Call Sure / On Call Sure Sync<br>Blood Glucose Monitoring System | On Call Sharp Blood Glucose<br>Monitoring System (K132084) |
| Operating<br>Temperature | 41-113°F (5-45°C) | 50-113°F (10-45°C) |
| Operating Relative<br>Humidity | 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<br>(without considering data transfer and<br>test reminder alarms) | Minimum of 1,000 measurements<br>(without considering data transfer<br>and 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 Deviation<br>mg/dL or<br>Coefficient of<br>Variation (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) or<br>Coefficient 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 % |

{13}------------------------------------------------

#### 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)<br>Plasma YSI Value |
|-------|---------------------------------------------------------|
|…