ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM

K132086 · ACON Laboratories, Inc. · NBW · Dec 19, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132086
• Device Name: ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: ACON Laboratories, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The On Call® Express Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearn and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative should be done only during steady-state times (when blocd glucose level is not changing rapidly). The On Callo Express 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® Express Blood Glucose Monitoring System in not intended for the diagnosis of or diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm. The On Call® Express Blood Glucose Control Solutions are for use with the On Call® Express Blood Glucose Meter and On Call® Express Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

Device Story

System measures glucose in capillary whole blood via amperometric detection; test strips contain glucose oxidase and mediator; meter calculates concentration from electrical current; displays plasma-equivalent results. Used by patients at home for diabetes management. Meter features auto-coding, 300-record memory, 4-second test time, 0.4 µL sample volume. Data port allows transfer. Benefits include convenient, rapid self-monitoring of blood glucose levels to aid in diabetes control.

Clinical Evidence

Clinical study conducted with lay persons and trained technicians comparing system performance to YSI Model 2300 STAT PLUS (K913806). Results demonstrated that nonprofessional, inexperienced lay users obtained blood glucose readings comparable to trained technicians. Users reported satisfaction with ease of operation and system performance. Bench testing included repeatability, precision, accuracy, linearity, and environmental stress testing per ISO 15197:2003.

Technological Characteristics

Electrochemical biosensor; FAD-Glucose Oxidase enzyme. No-code meter. Sample volume 0.4 uL. Measuring range 20-600 mg/dL. Connectivity: None (standalone). Sterilization: Not applicable (meter); test strips terminally sterilized. Standards: ISO 15197, EN 61010-1, EN 61326-1, EN 62304, ISO 14971.

Indications for Use

Indicated for people with diabetes for quantitative measurement of glucose in fresh capillary whole blood from fingertips, forearm, and palm as an aid in monitoring diabetes control programs. Not for neonates, screening, or diagnosis of diabetes. Not for critically ill, shock, severely dehydrated, 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

• On Call® Vivid Blood Glucose Monitoring System (K112653)

Submission Summary (Full Text)

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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 K132086 .

### Submitter's Identification:

ACON Laboratories, Inc.

10125 Mesa Rim Road

San Diego, California 92121

Tel.: [phone] Fax: [phone]

Date Prepared: August 21, 2013

### Contact Person:

Oiyi Xic Senior Staff, Clinical & Regulatory Affairs

## Proprietary Name of the Device:

40 On Call Express Blood Glucose Monitoring System

### Common Name:

Glucose Test System

### Classification Name:

Class II §862.1345 Glucose Test System

### Predicate Device:

On Call® Vivid Blood Glucose Monitoring System ACON Laboratories, Inc., located at 10125 Mesa Rim Road, CA 92121, USA. 510(k) Number: K112653

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

Device Name: On Call Express Blood Glucose Monitoring System

# Description:

The On Call Express 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* Express 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 by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steady-state times (when blood glucose level is not changing rapidly). The On Call ' Express 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 * Express Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabctes, nor intended for use on neonates.

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

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The On Call" Express Blood Glucose Control Solution is for use with the On Call" Express 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 | 0.4 µL |
| Test Time | 4 seconds |
| Power Source | One (1) CR 2032 3.0V coin cell battery |
| Battery Life | 1,000 tests for glucose testing (not considering data<br>transfer) |
| Glucose Units of<br>Measure | The meter is preset to mg/dL when sold in the<br>United States. |
| Memory | Up to 300 records with time and date |
| Automatic Shutoff | 2 minutes after last action |
| Meter Size | 3.46" x 1.93" x 0.65" |
| Display Size | 1.38" x 1.26" |
| Weight | Approximately 50 g (with battery installed) |
| Operating Temperature | 41-113°F (5-45°C) |
| Operating Relative<br>Humidity | 10-90% (non-condensing) |
| Hematocrit Range | 30-55% |
| Data Port | 9600 baud, 8 data bits, 1 stop bit, no parity |

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# Comparison to Predicate Devices:

| The On Call® Express Blood Glucose Monitoring System is substantially equivalent to |
|-------------------------------------------------------------------------------------|
| The On Call® Vivid Blood Glucose Monitoring System, K112653. |

| Features | On Call® Vivid Blood Glucose<br>Monitoring System (K112653) | On Call® Express Blood<br>Glucose Monitoring System |
|--------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Similarities | | |
| Result Calibration | Plasma-equivalent | Same |
| Sample Type | Fresh capillary whole blood | Same |
| Assay Method | Glucose oxidase | Same |
| Glucose Units of<br>Measure | mg/dL | Same |
| Operating Relative<br>Humidity | 10-90% | Same |
| Data Port | One Serial data port | Same |
| Measurement<br>Range | 20 to 600 mg/dL (1.1-33.3<br>mmol/L) | Same |
| Automatic Shutoff | Two minutes after last user action | Same |
| Battery Life | Minimum of 1,000 measurements<br>(without considering data transfer<br>and test reminder alarms) | Same |
| Coding | Auto Coding by meter automatic<br>recognition of the intended coding<br>after strip insertion | Same |
| Differences | | |
| Hematocrit Range | 25-70% | 30-55% |
| Operating<br>Temperature | 10-45°C (50-113°F) | 41-113°F (5-45°C) |
| Test Time | 5 seconds | 4 seconds |
| Minimum Sample<br>Size | 0.8 µL | 0.4 uL |
| Meter Memory | Up to 500 records with time and<br>date | Up to 300 records with time and<br>date |
| 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) | 3.46" x 1.93" x 0.65" |
| Meter Weight | Approx. 60 g (with battery<br>installed) | Approx. 50 g (with battery<br>installed) |
| Meter Display<br>Backlight | Yes | No |
| Meter Strip Port<br>Light | Yes | No |

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## Discussions 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 tcst 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:

(B) The performance characteristics of the On Call Express Blood Glucose Monitoring System were evaluated by performing the following safety and reliability testing per ISO 15197:2003, Section 6: repeatability precision, intermediate precision, accuracy evaluation, user performance, linearity, interfering agents, , altitude effect, system traceability, validation of calibration control materials, hematocrit effect, tcmperature effect evaluation - blood & control solution, low battery effect evaluation, , sample volume, temperature effect evaluation (blood and control solution), humidity offect, simulated shipping studies - test strip & control solution, accelerated Use Life (control & strip), 65° Accelerated Stability (Strip & Control), packaging, vibration, drop tests, temperature exposure, and humidity exposure, control value assignment, virucidal, efficacy validation, meter cleaning and disinfection, meter testing, software validation testing, electromagnetic compatibility and clectrical safety testing (per EN/IEC 61010-1 & 61010-2-101) 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 Express Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On Call Express 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 lau persons were able to obtain comparable blood glucose readings when using the On Call Express Blood Glucose Monitoring System as compared to the results obtained by the trained tcchnicians. 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 Express Blood Glucosc Monitoring System.

## Conclusion:

The laboratory testing and clinical study results demonstrate that the On Call Express Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the On

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®

Call Express Blood Glucose Monitoring System mets the accuracy requirements per EN ISO
I S197:2003 and as such is substantially equivalent to the On Call® Vivi Monitoring System, currently sold on the U.S. market (K 1 12653).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2013

ACON LABORATORIES, INC. QIYI XIE, M.D., MPH SR. STAFF (RA/CA) 10125 MESA RIM ROAD SAN DIEGO CA 92121

Re: K132086

Trade/Device Name: On Call Express Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: November 05, 2013 Received: November 06, 2013

Dear Dr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); 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-Dr. Xie

1f you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Carol G. Benson -S for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) k132086

#### Device Name

On Call® Express Blood Glucose Monitoring System

Indications for Use (Describe)

The On Call® Express Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearn and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative should be done only during steady-state times (when blocd glucose level is not changing rapidly).

The On Callo Express 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® Express Blood Glucose Monitoring System in not intended for the diagnosis of or diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

The On Call® Express Blood Glucose Control Solutions are for use with the On Call® Express Blood Glucose Meter and On Call® Express Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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