ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS

K112653 · ACON Laboratories, Inc. · JJX · Apr 9, 2012 · Clinical Chemistry

Device Facts

• Record ID: K112653
• Device Name: ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
• Applicant: ACON Laboratories, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The On Call® Vivid 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 during steady-state times (when blood glucose level is not changing rapidly). The On Call® Vivid Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. It is for in vitro diagnostic use only. The On Call® Vivid Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus or for neonatal use. The On Call® Vivid Blood Glucose Test Strips are used with the On Call Vivid Blood Glucose Meter in the quantitative measurement of glucose in fresh capillary blood from the fingertip, forearm, and palm. The On Call® Vivid Blood Glucose Control Solution is for use with the On Call® Vivid 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 measures capillary whole blood glucose via amperometric enzymatic assay; glucose oxidase chemistry generates electrical current proportional to glucose concentration. User applies 0.8 μL blood sample to test strip; meter displays quantitative result. Used at home by single patient; not for shared use. Includes meter, test strips, control solution, lancing device. Meter features automatic control solution recognition to prevent storage of control results as patient data. Provides monitoring aid for diabetes management; supports alternate site testing (fingertip, forearm, palm) during steady-state glucose conditions.

Clinical Evidence

No clinical data provided; device performance established via bench testing.

Technological Characteristics

Electrochemical enzymatic assay using glucose oxidase. Measurement range 20-600 mg/dL. Sample size 0.8 µL; test time 5 seconds. Powered by two 3.0V CR 2032 coin cell batteries. Dimensions 3.58" x 2.28" x 0.83". Data port: 9600 baud, 8 data bits, 1 stop bit, no parity. Hematocrit range 20-70%.

Indications for Use

Indicated for people with diabetes for quantitative glucose detection in fresh capillary whole blood (fingertip, forearm, palm) to monitor diabetes control programs. Not for neonates, diabetes diagnosis/screening, or critically ill/dehydrated/shock/hyper-osmolar patients.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• OneTouch Ultra Blood Glucose Monitoring System (k002134)

Submission Summary (Full Text)

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K112653

# APR - 9 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 _ _ _ _ _ ______________________________________________________________________________________________________________________________________

## 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:

Qiyi Xie Senior Staff, Clinical & Regulatory Affairs

#### Proprietary Name of the Device:

On Call" Vivid 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® Vivid<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® Vivid<br>Blood Glucose<br>Meter and On Call®<br>Vivid Blood<br>Glucose Test Strips | 862.1345<br>Class II | 75 CGA | Glucose Monitor | Glucose Meter &<br>Test Strips |
| On Call® Vivid<br>Glucose Control<br>Solution | 862.1660<br>Class I | 75 JJX | Single Analyte<br>Control | Control Solution |
| On Call® Lancets<br>and On Call®<br>Lancing Device | 878.4800<br>Class I | 79 FMK | Lancet, Blood | Lancets |

Device Name: On Call Vivid Blood Glucose Monitoring System

### Description:

The On Call Vivid 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 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® Vivid 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. Fingertip, forearm and palm testing sites should be used alternately only when blood glucose level is not changing rapidly. The On Call® Vivid 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.

- · This device is not indicated for the diagnosis or screening of diabetes.
- · Alternative site testing can be used only during steady-state blood glucose conditions.
- · Alternative site testing (AST) should not be used to calibrate continuous glucose monitors (CGMs) nor for use in insulin dose calculations.
- · The On Call Vivid Blood Glucose Meter and Strips are to be used with the On Call Vivid Blood Glucose Monitoring System; it measures glucose in capillary whole blood from the fingertip, forearm and palm.
- · For In Vitro Diagnostic Use

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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 µL |
| 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 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a human figure with three arms or wings extending upwards.

#### Public Health Service

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

Acon Laboratories, Inc. c/o Qiyi Xie 10125 Mesa Rim Rd. San Diego, CA 92121

k112653 Re:

APR - 9 2012

KT12055
Trade Name: On Call Vivid Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: CGA, NBW, JJX Dated: March 17, 2012 Received: March 19, 2012

Dear Dr. Xie:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave leviewed your Section STO(s) promised is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the enclosers, to teenactment date of the Medical Device interstate commerce prior to May 20, 1970, cases as the est receives approval of a premarket Amendments, or to devices that have been reculties that require approval of a premaint the Federal Food, Drug, and Costient Act (rec) market the device, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the ge approval application (f MA). Tou may, increase of the Act include controls provisions of the Act. The gential of devices, good manufacturing practice, increases for labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III If your device is classified (ec above) into controls. Existing major regulations affecting (PMA), it may be subject to Such adultional Collections (CFR), Patis 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 800 your device can be found in Title ZT, Code of Pederal Regulation (1 - 1)
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 Please be advised that FDA s Issualite of a substitives with other requirements
mean that FDA has made a determination that your devices with other Federal agencies, mean that FDA has made a delemination that your and regulations by other Federal agencies.
of the Act or any Federal statutes and regulations and regulations gencies. of the Act or any Federal statues and reginations and limited to: registration
You must comply with all the Act's requirements, including, but not ical device You must comply with an the Act 3 requirently and 809); medical device
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and go and listing (21 CFK Part 807), labeling (21 Creates events) (21 CFR 803); and good
reporting (reporting of medical device-related adverse events) (21 CFR 803); and good reporting (reporting of medical device-related adverse evensy (2008) 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 Vitro 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 reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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,

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

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): _ 510(k) Number (if known): _ 5 10(k) Number (if known): 3 5 2

Device Name:

On Call® Vivid Blood Glucose Monitoring System

The On Call® Vivid 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 during steady-state times (when blood glucose level is not changing rapidly). The On Call® Vivid Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. It is for in vitro diagnostic use only.

The On Call® Vivid Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus or for neonatal use.

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

The On Call® Vivid Blood Glucose Control Solution is for use with the On Call® Vivid 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

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

Signature

Division Sign-off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k) 12112653