ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM

K090057 · Acon Laboratories Co. · NBW · Apr 8, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090057
• Device Name: ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Acon Laboratories Co.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The On-Call® Plus Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in capillary whole blood from the fingertip, forearm, and/or palm by people with diabetes at home and by healthcare professionals as an aid in the monitoring the effectiveness of diabetes control programs. The On-Call® Plus 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® Plus Blood Glucose control solution is for use with the On-Call® Plus 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 sample (1 µL) applied to test strip containing glucose oxidase and mediator; meter measures electrical current generated by reaction; calculates glucose concentration; displays plasma-equivalent result. Used by patients at home or healthcare professionals in clinics. Provides quantitative blood glucose readings to monitor diabetes control programs. Includes memory for 300 records with time/date stamps. Data port allows transfer of stored records. System includes meter, test strips, and control solution for quality verification. Benefits include portable, rapid monitoring of glycemic status.

Clinical Evidence

Clinical study conducted with lay persons and trained technicians. Compared On-Call® Plus system accuracy against YSI Model 2300 STAT PLUS reference. Results demonstrated lay persons obtained readings comparable to trained technicians. Users reported satisfaction with ease of operation and performance. Bench testing included repeatability, intermediate precision, linearity, interference, hematocrit (30-55%), temperature, altitude, and sample volume effects. System met ISO 15197 accuracy requirements.

Technological Characteristics

Electrochemical enzymatic assay (glucose oxidase biosensor). Powered by 3.0V CR 2032 coin cell battery. Dimensions: 85mm x 54mm x 20.5mm. Weight: 49.5g. Data port: 9600 baud, 8 data bits, 1 stop bit, no parity. Operating range: 1.1-33.3 mmol/L (20-600 mg/dL). Hematocrit range: 30-55%. Plasma-equivalent calibration.

Indications for Use

Indicated for people with diabetes and healthcare professionals for quantitative glucose monitoring in capillary whole blood (fingertip, forearm, palm). Not for neonates, diabetes diagnosis, or screening. Contraindicated for patients who are dehydrated, 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

• One Touch Ultra Blood Glucose Monitoring System (K002134)

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 | k0910057 |
|-------------------------------|----------|
|-------------------------------|----------|

# Submitter's Identification:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel.: [phone] Fax: [phone]

Date Prepared: January 7, 2009

# Contact Person:

Richard Lenart Regulatory Affairs Manager

# Proprietary Name of the Device:

On-Call® Plus Blood Glucose Monitoring System

### Common Name:

Glucose Test System

### Classification Name:

Class II §862.1345 Glucose Test System (To be manufactured and marketed for consumer home and professional use)

# Predicate Device:

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

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| Proprietary Name | Classification | ProCode | Description | Common Name |
|----------------------------------------------------------------------------------------|----------------------|---------|-----------------------------------------------------|--------------------------------|
| On-Call® Plus Blood<br>Glucose Monitoring<br>System | 862.1345<br>Class II | 75 NBW | System, Test,<br>Blood Glucose,<br>Over The Counter | Glucose Test<br>System |
| On-Call® Plus Blood<br>Glucose Meter and<br>On-Call® Plus Blood<br>Glucose Test Strips | 862.1345<br>Class II | 75 CGA | Glucose Monitor | Glucose Meter &<br>Test Strips |
| On-Call® Plus Glucose<br>Control Solution | 862.1660<br>Class I | 75 JJX | Single Analyte<br>Control | Control Solution |
| On-Call® Plus Lancets and<br>On-Call® Plus Lancing<br>Device | 878.4800<br>Class I | 79 FMK | Lancet, Blood | Lancets |

Device Name: On-Call® Plus Blood Glucose Monitoring System

#### Description:

The On-Call® Plus Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm, and/or 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® Plus Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in capillary whole blood from the fingertip, forearm, and/or palm by people with diabetes at home and by healthcare professionals as an aid in the monitoring the effectiveness of diabetes control programs.

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# Technological Characteristics:

| Feature | Specification |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement Range | 1.1-33.3 mmol/L (20 to 600 mg/dL) |
| Result Calibration | Plasma-equivalent |
| Sample | Fresh capillary whole blood |
| Minimum Sample Size | 1 μL |
| Test Time | 10 seconds |
| Power Source | One (1) CR 2032 3.0V coin cell battery |
| Battery Life | 12 months or approximately 1,000 tests |
| Glucose Units of Measure | The meter is pre-set at time of manufacturing to either millimoles per<br>liter (mmol/L) or milligrams per deciliter (mg/dL) depending on the<br>country of use standard |
| Memory | Up to 300 records with time and date |
| Meter Size | 85 mm x 54 mm x 20.5 mm |
| Display Size | 35 mm x 32.5 mm |
| Weight | Approximately 49.5 g (with battery installed) |
| Operating Temperature | 5-45°C (41 - 113°F) |
| Operating Relative Humidity | 20-90% (non-condensing) |
| Hematocrit Range | 30-55% |
| Data Port | 9600 baud, 8 data bits, 1 stop bit, no parity |
| Sample Site | Fingertip, palm and forearm |

Specification of Blood Glucose Meter:

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### Comparison to Predicate Devices:

The On-Call® Plus Blood Glucose Monitoring System is substantially equivalent to the One Touch Ultra Blood Glucose Monitoring System, K002134.

| Features | On-Call® Plus Blood Glucose<br>Monitoring System | One Touch Ultra Blood<br>Glucose Monitoring<br>System (K002134) |
|-----------------------------|--------------------------------------------------|-----------------------------------------------------------------|
| Similarities | | |
| Measurement Range | 20 to 600 mg/dL (1.1-33.3 mmol/L) | Same |
| Result Calibration | Plasma-equivalent | Same |
| Sample | Fresh capillary whole blood | Same |
| Minimum Sample Size | 1 µL | Same |
| Assay Method | Glucose oxidase biosensor | Same |
| Power Source | One (1) CR 2032 3.0V coin cell battery | Same |
| Battery Life | 12 months or approximately 1,000 tests | Same |
| Glucose Units of Measure | mg/dL | Same |
| Hematocrit Range | 30-55% | Same |
| Automatic Shutoff | Two minutes after last user action | Same |
| Data Port | One data port | Same |
| Differences | | |
| Test Time | 10 seconds | 5 seconds |
| Memory | Up to 300 records with time and date | 150 blood glucose and control<br>solution tests |
| Meter Size | 85 mm x 54 mm x 20.5 mm | 3.12" x 2.25" x 0.85" |
| Weight | Approximately 49.5 g (with battery installed) | 1.5 ounces with battery<br>(Approximately 42 g) |
| Operating Temperature | 5-45°C (41 - 113°F) | 6-44°C (43 - 111°F) |
| Operating Relative Humidity | 20-90% (non-condensing) | 10-90% |
| Sample Site | Fingertip, palm and forearm | Fingertip and forearm |

# 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".

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#### Laboratory Testing:

The performance characteristics of the On-Call® Plus 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, 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® Plus Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the On-Call® Plus 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 non-professional, inexperienced lay persons were able to obtain comparable blood glucose readings when using the On-Call® Plus 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® Plus Blood Glucose Monitoring System.

#### Conclusion:

The laboratory testing and clinical study results demonstrate that the On-Call® Plus Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the On-Call® Plus Blood Glucose Monitoring System meets the accuracy requirements per 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Acon Laboratories Co. c/o Mr. Richard Lenart 4108 Sorrento Valley Blvd. San Diego, CA 92121

APR - 8 2009

Re: k090057 Trade/Device Name: On-Call Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: January 07, 2009 Received: January 08, 2009

Dear Mr. Lenart:

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 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page - 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

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

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# Indication for Use

510(k) Number (if known): k090057

Device Name: On-Call® Plus Blood Glucose Monitoring System

Indication For Use:

The On-Call® Plus Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in capillary whole blood from the fingertip, forearm, and/or palm by people with diabetes at home and by healthcare professionals as an aid in the monitoring the effectiveness of diabetes control programs.

The On-Call® Plus 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® Plus Blood Glucose control solution is for use with the On-Call® Plus Blood Glucose meter and strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use (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 Diagnostic Device Evaluation and Safety (OVD)

Rute Chelin

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

k090057 510(k)