ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM

K123010 · ACON Laboratories, Inc. · NBW · Dec 14, 2012 · Clinical Chemistry

Device Facts

• Record ID: K123010
• Device Name: ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: ACON Laboratories, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The On Call® Vivid Pro Blood Glucose Monitoring System is an electrochemical enzymatic assay. It is used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. The On Call® Vivid Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto-disabling lancing devices. The On Call® Vivid Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. The On Call® Vivid Pro Blood Glucose Test Strips are used with the On Call Vivid Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the finger. The On Call® Vivid Pro Blood Glucose Control Solutions are for use with the On Call® Vivid Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Story

System uses electrochemical enzymatic assay to measure glucose in capillary whole blood. Input: 0.8 µL blood sample applied to test strip containing glucose oxidase and mediator. Meter measures electrical current generated by reaction; calculates glucose concentration; displays result calibrated to plasma reference. Used in healthcare facilities by professionals for diabetes management. Output: quantitative blood glucose reading. Benefits: aids monitoring of diabetes control programs. Features auto-coding upon strip insertion. Quality control performed via aqueous glucose control solution.

Clinical Evidence

Clinical study conducted with lay persons and trained technicians comparing system results to YSI Model 2300 STAT PLUS reference. Results demonstrated that nonprofessional, inexperienced lay users obtained blood glucose readings comparable to trained technicians. Users reported satisfaction with ease of operation and performance. Bench testing included repeatability, intermediate precision, linearity, and environmental stress testing (temperature, humidity, altitude).

Technological Characteristics

Electrochemical enzymatic biosensor; glucose oxidase reagent. Measurement range 20-600 mg/dL. Sample: 0.8 µL capillary blood. Power: 2x CR 2032 3.0V batteries. Connectivity: Serial data port (9600 baud). Dimensions: 3.58" x 2.28" x 0.83". Operating range: 5-45°C, 10-90% RH. Hematocrit range: 20-70%. Auto-coding via strip recognition.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from the fingertip in patients requiring diabetes control monitoring. Intended for multiple patient use by healthcare professionals in clinical settings. Contraindicated for neonates and not intended for diabetes diagnosis or screening.

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

• One Touch® Ultra® Blood Glucose Monitoring System (K002134)

Submission Summary (Full Text)

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# DEC 1 4 2012

## 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 k123010

## Submitter's Identification:

ACON Laboratories, Inc.

10125 Mesa Rim Road

San Diego, California 92121

Tel.: [phone] Fax: [phone]

Date Prepared: December 14, 2012

## Contact Person:

Qiyi Xie Senior Staff, Clinical & Regulatory Affairs

#### Proprietary Name of the Device:

On Call Vivid Pro Blood Glucose Monitoring System

## Common Name:

Glucose Test System

### Classification Name:

Class II §862.1345 Glucose Test System

## Predicate Device:

One Touch® Ultra® Blood Glucose Monitoring System Lifescan, Inc., located at 1000 Gibraltar Dr., Milpitas, CA 95035, USA. 510(k) Number: K002134

Device Name: On Call Vivid Pro Blood Glucose Monitoring System

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| Proprietary Name | Classification | Product<br>Code | Description | Common Name |
|-----------------------------------------------------------------------------------------------------|----------------------|-----------------|-------------------------------------------------|--------------------------------|
| On Call® Vivid Pro<br>Blood Glucose<br>Monitoring System | 862.1345<br>Class II | 75 NBW | System, Test,<br>Blood Glucose,<br>Prescription | Glucose Tést<br>System |
| On Call® Vivid Pro<br>Blood Glucose<br>Meter and On Call®<br>Vivid Pro Blood<br>Glucose Test Strips | 862.1345<br>Class II | 75 CGA | Glucose Monitor | Glucose Meter &<br>Test Strips |
| On Call® Vivid Pro<br>Glucose Control<br>Solution | 862.1660<br>Class I | 75 JJX | Single Analyte<br>Control | Control Solution |

### Description:

The On Call" Vivid Pro Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. The glucose measurement is achieved by using the amperometric detection method.

The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.

The quality control of the On Call Vivid Pro Blood Glucose Monitoring System is performed by testing the test strip on meter with glucose control solution to confirm that the test strip and meter are working together properly. The glucose control solution contains a known concentration of glucose with preservatives in an aqueous based mixture. The control solution test result should fall within the predetermined control solution range for the given strip lot to confirm the accuracy of the On Call Vivid Pro Blood Glucose Monitoring System.

### Intended Use:

The On Call® Vivid Pro Blood Glucose Monitoring System is an electrochemical enzymatic assay. It is used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. The On Call® Vivid Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto-disabling lancing devices.

The On Call® Vivid Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.

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The On Call® Vivid Pro Blood Glucose Test Strips are used with the On Call Vivid Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the finger.

The On Call® Vivid Pro Blood Glucose Control Solutions are for use with the On Call® Vivid Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.

## Technological Characteristics:

Specification of Blood Glucose Meter:

| Feature | Specification |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement Range | 20 to 600 mg/dL (1.1-33.3 mmol/L) |
| Result Calibration | Plasma-equivalent |
| Sample | Fresh capillary whole blood |
| Minimum Sample Size | 0.8 µL |
| Test Time | 5 seconds |
| Power Source | Two (2) CR 2032 3.0V coin cell batteries |
| Battery Life | Minimum of 1,000 measurements (without considering data<br>transfer and test reminder alarms) |
| Glucose Units of<br>Measure | The meter is pre-set at time of manufacturing to either<br>millimoles per liter (mmol/L) or milligrams per deciliter<br>(mg/dL) depending on the standard of your country. The meter<br>will be set to mg/dL by default when sold in the United States. |
| Memory | Up to 500 records with time and date |
| Meter Size | 3.58" x 2.28" x 0.83" |
| Display Size | 1.58" x 1.42" |
| Weight | Approximately 60 g (without battery installed) |
| Operating<br>Temperature | 5-45°C (41-113°F) |
| Operating Relative<br>Humidity | 10-90% (non-condensing) |
| Hematocrit Range | 20-70% |
| Data Port | 9600 baud, 8 data bits, 1 stop bit, no parity |

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## Comparison to Predicate Devices:

The On Call" Vivid Pro Blood Glucose Monitoring System is substantially equivalent to One Touch Ultra Blood Glucose Monitoring System, K002134.

| Features | On Call® Vivid Pro Blood Glucose<br>Monitoring System | One Touch Ultra Blood Glucose<br>Monitoring System (K002134) |
|--------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Similarities | | |
| Assay Method | Glucose oxidase biosensor | Same |
| Result Calibration | Plasma-equivalent | Same |
| Test Time | 5 seconds | Same |
| Sample Type | Fresh capillary whole blood | Same |
| Glucose Units of<br>Measure | mg/dL | Same |
| Operating Relative<br>Humidity | 10-90% | Same |
| Data Port | One Serial data port | Same |
| Measurement Range | 20 to 600 mg/dL (1.1-33.3 mmol/L) | Same |
| Automatic Shutoff | Two minutes after last user action | Same |
| Battery Life | Minimum of 1,000 measurements<br>(without considering data transfer and<br>test reminder alarms) | 1,000 tests |
| Differences | | |
| Minimum Sample<br>Size · | 0.8 µL | 1.0 µL |
| Hematocrit Range | 20-70% | 30-55% |
| Operating<br>Temperature | 5-45°C (41-113°F) | 6-44°C (43-111°F) |
| Coding | Auto Coding by meter automatic<br>recognition of the intended coding<br>after strip insertion | Manual Coding by manually<br>selecting code by pressing button |
| Meter Memory | Up to 500 records with time and date | 150 blood glucose and control<br>solution tests |
| Power Source | Two (2) CR 2032 3.0 V coin cell<br>batteries | One (1) CR 2032 3.0V coin cell<br>battery |
| Meter Size | 3.53" x 2.28" x 0.85"<br>(89.6mm x 58mm x 21.7mm) | 3.12" x 2.25" x 0.85" |
| Meter Weight | Approx. 60 g (with battery installed) | 1.5 ounces with battery<br>(Approximately 42 g) |

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## Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Guidance documents included the "FDA Guidance for Industry In Vitro Diagnostic Glucose Test System" and "FDA Guidance for Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems" as well as "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Compliance to applicable voluntary standards includes EN ISO 15197:2003 "In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus."

## Laboratory Testing:

The performance characteristics of the On Call Vivid Pro Blood Glucose Monitoring System were evaluated by performing 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.

## Discussion of Clinical Tests Performed:

Clinical studies were conducted with lay persons and trained laboratory technicians using the On Call Vivid Pro Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On Call Vivid Pro 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 nonprofessional, inexperienced lay persons were able to obtain comparable blood glucose readings when using the On Call Vivid Pro Blood Glucose Monitoring System as compared to the 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 "Vivid Pro Blood Glucose Monitoring System.

## Conclusion:

The laboratory testing and clinical study results demonstrate that the On Call Vivid Pro Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the On Call Vivid Pro Blood Glucose Monitoring System meets the accuracy requirements per EN ISO 15197 and as such is substantially equivalent to the One Touch Ultra Blood Glucose Monitoring System, currently sold on the U.S. market (K002134).

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes extending from its head, representing the department's commitment to health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle symbol.

## DEPARTMENT OF HEALTH & HUM AN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### December 14, 2012

ACON Laboratories, Inc. c/o Qivi Xie 10125 Mesa Rim Road San Diego, CA 92121

Re: k123010

Trade/Device Name: On Call® Vivid Pro Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: September 26, 2012 Received: September 27, 2012

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Qiyi Xie ·

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at [phone]. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

#### Carol C. Benson for

Courtney H. Lias, Ph.D. Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K123010

Device Name: On Call® Vivid Pro Blood Glucose Monitoring System

Indications for Use:

The On Call® Vivid Pro Blood Glucose Monitoring System is an electrochemical enzymatic assay. It is used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. The On Call® Vivid Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, autodisabling lancing devices.

The On Call® Vivid Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.

The On Call® Vivid Pro Blood Glucose Test Strips are used with the On Call Vivid Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the finger.

The On Call® Vivid Pro Blood Glucose Control Solutions are for use with the On Call® Vivid Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _x (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Kothaus

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123010

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