ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM

K111371 · ACON Laboratories, Inc. · CGA · Oct 6, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111371
• Device Name: ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: ACON Laboratories, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Oct 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The On Call® Chosen Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only when glucose is not changing rapidly. The On Call® Chosen Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only. The On Call® Chosen Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for use with neonates. The On Call® Chosen Test Strips are used with the On Call® Chosen Blood Glucose Meter in the quantitative measurement of glucose in fresh capillary blood from the fingertip, forearm and palm. The On Call® Chosen Control Solution is for use with the On Call® Chosen Blood Glucose Meter and Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

Device Story

System uses electrochemical enzymatic assay to measure glucose in capillary whole blood; input sample (0.8 µL) applied to test strip containing glucose oxidase and mediator; reagent reaction produces electrical current proportional to glucose concentration; meter calculates and displays plasma-equivalent glucose concentration. Used by patients at home for diabetes management; operated by single patient. Healthcare providers use displayed results to assess effectiveness of diabetes control programs. System includes meter, test strips, and control solution for quality verification. Provides quantitative glucose readings to aid patient self-monitoring.

Clinical Evidence

Clinical study conducted with lay persons and trained technicians comparing On Call Chosen system to YSI Model 2300 STAT PLUS. 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 precision, linearity, interfering agents, hematocrit, temperature, altitude, and software validation.

Technological Characteristics

Electrochemical enzymatic assay (glucose oxidase). Measurement range 20-600 mg/dL. Sample size 0.8 µL. Test time 5 seconds. Hematocrit range 20-70%. Power: two 3.0V CR 2032 batteries. Data port: serial (9600 baud). Compliance with EN ISO 15197:2003.

Indications for Use

Indicated for people with diabetes for quantitative glucose monitoring in fresh capillary whole blood (fingertip, forearm, palm) at home. Contraindicated for neonatal use, diabetes screening/diagnosis, critically ill patients, patients in shock, dehydrated patients, or hyper-osmolar patients.

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

• OneTouch Ultra Blood Glucose Monitoring System (k002134)
• OneTouch Select control solutions (k002134)

Submission Summary (Full Text)

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### 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 k111371 - .

### Submitter's Identification:

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

Tel.: [phone] Fax: [phone]

Date Prepared: May 14, 2011

### Contact Person:

Oivi Xie Senior Staff, Clinical & Regulatory Affairs

### Proprietary Name of the Device:

On Call Chosen 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

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

Device Name: On Call Chosen Blood Glucose Monitoring System

### Description:

The On Call "Chosen Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm, and forearm. 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.

### Intended Use:

The On Call® Chosen Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate (forearm and palm) testing sites should be used only when blood glucose level is not changing rapidly. The On Call® Chosen Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.

The On Call Chosen Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates.

The On Call Chosen Blood Glucose Test Strips are used with the On Call Chosen Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.

The On Call Chosen Blood Glucose Control Solution is for use with the On Call Chosen Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

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# Technological Characteristics:

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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 uL | |
| Test Time | 5 seconds | |
| Power Source | Two (2) CR 2032 3.0V coin cell batteries | |
| Battery Life | Minimum of 3,000 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 300 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<br>RelativeHumidity | 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" Chosen Blood Glucose Monitoring System is substantially equivalent to One Touch Ultra Blood Glucose Monitoring System, K002134.

| Features | On Call® Chosen Blood Glucose<br>Monitoring System | One Touch Ultra Blood<br>Glucose Monitoring System<br>(K002134) |
|------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Similarities | | |
| Assay Method | Glucose oxidase biosensor | Same |
| Strip Chemical<br>Composition | | 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 |
| Automatic Shutoff | Two minutes after last user action | Same |
| Measurement Range | 20 to 600 mg/dL (1.1-33.3 mmol/L) | Same |
| 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) |
| Alternative Sample<br>Site for Capillary | Palm and forearm in addition to<br>fingertip | Fingertip and forearm |
| Meter Memory | Up to 300 records with time and date | 150 blood glucose and control<br>solution tests |
| Battery Life | Minimum of 3,000 measurements<br>(without considering data transfer and<br>test reminder alarms) | 1,000 tests |
| Power Source | Two (2) CR 2032 3.0V coin cell<br>batteries | One (1) CR 2032 3.0V coin cell<br>battery |
| Meter Size | 3.58" x 2.28" x 0.83" | 3.12" x 2.25" x 0.85" |
| Meter Weight | Approx. 60 g (without battery<br>installed) | 1.5 ounces with battery<br>(Approximately 42 g) |

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The On Call " Chosen Blood Glucose Monitoring System Control Solution is substantially equivalent to One Touch Ultra Blood Glucose Monitoring System Control Solution, K002134.

| Features | On Call® Chosen Blood Glucose<br>Monitoring System<br>Control Solution | One Touch Ultra Blood Glucose<br>Monitoring System Control<br>Solution (K002134) |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | On Call® Chosen Control Solution<br>contains a known concentration of<br>glucose and it is used to confirm the<br>test strips and the blood glucose meter<br>are working together properly and<br>that you are performing the test<br>correctly. | To check that the meter and test<br>strips are working together as a<br>system and that you are<br>performing the test correctly. It is<br>very important that you do control<br>solution tests routinely to make<br>sure you are getting accurate<br>results. |
| Format | Liquid solution<br>On Call® Chosen Control solution 1<br>has less than 0.2% glucose (active<br>ingredient). Control Solution 2 has<br>less than 0.4% glucose (active<br>ingredient). Both solutions have<br>preservatives in water based mixture. | Liquid solution<br>OneTouch® Ultra™ Control<br>Solution is a red solution that<br>contains about 0.11% D-glucose.<br>It also contains: Sodium benzoate<br>0.2%; Disodium EDTA 0.1%;<br>FD&C red Dye 0.2%;<br>Viscosity-adjusting agent 8.0% |
| Stability | 6 Months after first opening | 3 Months after first opening |

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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 Chosen 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 Chosen Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On Call Chosen 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 Chosen 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 Chosen Blood Glucose Monitoring System.

### Conclusion:

The laboratory testing and clinical study results demonstrate that the On Call Chosen Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the On Call Chosen 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/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird with outstretched wings, which is a common symbol associated with the department.

Food and Druq Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Acon Laboratories Inc. c/o Mr. Qiyi Xie Sr. Staff Regulatory/Clinical Affairs 10125 Mesa Rim Rd., San Diego, CA 92121

OCT - 6 2011

રિણ: k111371

> Trade Name: On-Call Chosen Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: CGA, NBW, JJX Dated: September 21, 2011 Received: September 22, 2011

Dear Mr. 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 approvat 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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895, 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 ther requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (2) CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reportine of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

z

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known):

Device Name: On Call Chosen Blood Glucose Monitoring System

Indications for Use:

The On Call® Chosen Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate (forearm and palm) testing sites should be used only when blood glucose level is not changing rapidly. The On Call® Chosen Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.

The On Call Chosen Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates.

The On Call Chosen Blood Glucose Test Strips are used with the On Call Chosen Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.

The On Call Chosen Blood Glucose Control Solution is for use with the On Call Chosen Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

CARS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) | k11137 |
|--------|--------|
|--------|--------|

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