GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM

K061234 · Glucoplus, Inc. · NBW · Oct 30, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061234
• Device Name: GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Glucoplus, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Glucoplus™ Blood Glucose Test System is comprised of Control Solutions and Test Strip biosensors for use only with the Glucoplus™ Blood Glucose Meter. It is for quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingerstick by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

GlucoPlus Blood Glucose Monitoring System measures glucose in capillary whole blood. System includes hand-held meter, test strips, and control solutions. User inserts strip, applies finger-tip blood, and meter performs electrochemical assay using glucose oxidase and potassium ferricyanide. Meter software converts electrical current increase into plasma-equivalent glucose concentration, displaying result on LCD. Used at home by patients or in clinical settings by healthcare professionals. Provides quantitative glucose values to aid diabetes management. Benefits include rapid monitoring of blood glucose levels to assess treatment effectiveness.

Clinical Evidence

Performance validated via bench testing and clinical studies. Precision evaluated per CLSI EP5-T2; within-run CV 2.1-3.9%, between-day CV 2.5-3.3%. Linearity confirmed (R=0.999) across 44-596 mg/dL. Consumer study (n=120) and POC study (n=100) compared GlucoPlus to YSI reference and predicate; results showed high correlation (r=0.985-0.997). Interference testing identified potential positive bias for L-dopa, tetracycline, and uric acid.

Technological Characteristics

Electrochemical biosensor using glucose oxidase enzyme. Power: 3V lithium battery (CR 2032). Connectivity: RS232 or USB interface for data download. Measuring range: 40-600 mg/dL. Hematocrit range: 30-55%. Sample volume: 1.5 µL. Test time: <15 seconds.

Indications for Use

Indicated for quantitative measurement of glucose concentration in capillary whole blood from fingersticks by people with diabetes at home or by healthcare professionals in clinical settings to monitor diabetes control effectiveness. Not for diagnosis or screening of diabetes mellitus. Not for use on neonates.

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

• GLUCOMETER ELITE Blood Glucose meter (k964630)

Submission Summary (Full Text)

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# 510(k) Summary

This summary of the 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92

510(k) Number K061234

Sponsor:

GlucoPlus Inc. 2323 Halpern Ville St-Laurent, Quebec Canada H4S 1S3

Contact Information:

### Jeffrey Fleishman Official Correspondent 215 815-0897 Fax 215 – 860-1071 [e-mail]

Date Prepared: April 25, 2006

Proprietary Name: GlucoPlus™ Blood Glucose Monitoring System

Common Name: Blood Glucose Monitoring System

| Classification Name: | Product Code | Device Class | Regulatory<br>Numbers |
|--------------------------------------------------------------------------------------------|--------------|--------------|-----------------------|
| Test, Blood Glucose System Over<br>the Counter | NBW | 2 | 21 CFR 862.1345 |
| Glucose Oxidase | CGA | 2 | |
| Single (Specified) analyte controls<br>(assayed and unassayed)<br>Quality Control Material | JJX | 1 | 21 CFR 862.1345 |

Panel: (75) Chemistry

Predicate Device: GLUCOMETER ELITE Blood Glucose meter

Manufacturer: Bayer Corporation

510(k) Number k964630

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- Device Description: GlucoPlus™ Blood Glucose Monitoring System is comprised of an electrchemical biosensor glucose reagent test strip, a hand held meter, quality control solutions, a user manual, a check strip, a lancet, lancets and a logbook for recording test results. When the user inserts a test strip , the meter turns on. The user acquires a blood sample by touching the aperture of the test strip to the finger tip blood drop to fill the chamber on the strip. The meter sounds a beep to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its LCD.
#### Similarities with Predicate Device:

| Feature / Claim | Detail |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The GlucoplusTM Blood Glucose Test System is comprised<br>of Control Solutions and Test Strip biosensors for use only<br>with the GlucoplusTM Blood Glucose Meter. It is for<br>quantitative measurement of the concentration of glucose in<br>capillary whole blood taken from the fingerstick by people<br>with diabetes at home and/or by healthcare professionals in<br>a clinical setting as an aid to monitor the effectiveness of<br>diabetes control.<br><br>It is not intended for the diagnosis of or screening for<br>diabetes mellitus, and is not intended for use on neonates. |
| Test Principle | GlucoPlusTM Blood Glucose Monitoring System utilizes a<br>test strip that contains the enzyme glucose oxidase and a<br>glucose meter. After the blood is drawn into the test strip,<br>glucose in the sample reacts with potassium ferricyanide in<br>the test strip producing potassium ferrocyanide. Potassium<br>ferrocyanide is produced in proportion to the glucose<br>concentration in the blood sample. Oxidation of the<br>potassium ferrocyanide produces an electrical current<br>which is then converted by the meter to display the glucose<br>concentration of the blood sample. |
| Warnings and<br>Precautions | For in vitro diagnostic use. |
| Sample Types | Fresh capillary whole blood samples from a fingerstick. |
| Hematocrit Range | 30 – 55% |
| Power Source | 3 V lithium battery (CR 2032) |
| Battery Use Life | More than 1000 tests |

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## Differences with Predicate Device:

:

| Feature | GlucoPlus TM | Glucometer Elite™ |
|------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Blood Sampling<br>Into Strip | Double Sided<br>(Right or Left) | Sip- in Sampling<br>Front end only |
| Sample Volume | 1.5 µL | 2.0 µL |
| Strip Packaging | 25 Strips stored in a vial | Single strip in foil package. |
| Measuring time | Within 15 seconds | Within 30 seconds |
| Measuring Range | 40 - 600 mg/dL | 20 - 600 mg / dL |
| Measuring Unit | Test results are displayed in<br>either mg/dl or mmol/L<br>depending on the meter setting. | mg/dl or mmol/L |
| Buttons | 3 Buttons<br>Center Button: Power<br>Left Button: Setting Functions<br>Right Button: Memory Functions | No Buttons |
| Setting Functions | Date, Time, Unit of Measure | None |
| Calibration | Built in Button | Calibration Strip |
| Data Download | Test Results can download by<br>RS232 or USB interface | N/A |
| Average Display | Calculate mean results within<br>1,7,14,21 and 28 days | Total mean results only. |
| Control Test Mode | N/A | The Control solution test<br>result will not store into<br>memory. |
| Flashing Strip<br>Symbol | Flashing Strip Symbol will display<br>when meter is powered on. | N/A |
| Ready to Test<br>Symbol | User can apply blood to strip<br>after the display on LCD appears | The Function Number (F#)<br>and the previous test result<br>begin flashing alternately. |

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Data Demonstrating Substantial Equivalence:

The results of the consumer and point of care studies demonstrate good correlation (R>0.98) between ~40 - ~550 mg/dl in capillary whole blood specimens. The regression analysis of the data supports the Substantial Equivalency claim with the predicate device.

## Consumer Study

## Linear regression between GlucoPlus™ and YSI for lay users and technician

| Accuracy of lay users compared to<br>YSI using capillary whole blood on<br>120 specimens at clinical centers | N=120<br>$Y=0.96X-7.90$<br>R=0.985<br>Sy.x= 12.90<br>Range=57-481 mg/dL |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Accuracy of technician compared to<br>YSI using capillary whole blood on<br>120 specimens at clinical centers | N=120<br>$Y=0.95X-6.60$<br>R=0.989<br>Sy.x=10.75<br>Range=57-481 mg/dL |

### Point of Care Study Linear regression between GlucoPlus™ and GLUCOMETER ELITE® for test on department of Home Medical, Internal, and Metabolism

| Home Medical | Metabolism | Internal | Total |
|--------------------|--------------------|--------------------|--------------------|
| N=58 | N=62 | N=80 | N=200 |
| Y=1.054X-6.34 | Y= 1.031X-6.06 | Y=1.046X-4.83 | Y= 1.045X-5.81 |
| R=0.990 | R=0.986 | R=0.997 | R= 0.994 |
| Sy.x=11.93 | Sy.x=15.87 | Sy.x=11.98 | Sy.x=13.30 |
| Range=59-341 mg/dL | Range=56-392 mg/dL | Range=38-548 mg/dL | Range=38-548 mg/dL |

### System accuracy results.

| | Glucose concentration < 75 mg/dL | |
|----------------|----------------------------------|-----------------|
| Within 5 mg/dL | Winthin 10 mg/dL | Within 15 mg/dL |
| 14/28 (50%) | 25/28 (89.3%) | 28/28 (100% |
| | Glucose concentration □ 75 mg/dL | |

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| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
|----------------|-----------------|---------------|-----------------|
| 58/172 (33.7%) | 130/172 (75.6%) | 160/172 (93%) | 170/172 (98.8%) |

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## Conclusion:

The description and data comparing the GlucoPlus™ and GLUCOMETER ELITE® system functions, intended use, hardware and software, laboratory and clinical evaluations supports the substantial equivalency claim to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

GlucoPlus Inc. c/o Mr. Jeffrey Fleishman Plasma Services Group, Inc. 315 Parkview Way Newtown, PA 18940

OCT 3 0 2006

Re: k061234 Trade/Device Name: Glucoplus™ Blood Glucose Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: October 2, 2006 Received: October 4, 2006

Dear Mr. Fleishman:

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/industry/support/index.html.

Sincerely yours,

Alberto Garcia

Alberto Gutierrez, 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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# Indication of Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Glucoplus™ Blood Glucose Test System

Indications for Use:

The Glucoplus™ Blood Glucose Test System is comprised of Control Solutions and Test Strip biosensors for use only with the Glucoplus™ Blood Glucose Meter. It is for quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingerstick by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Prescription Use X (Part 21 CFR §801 Subpart D)

AND / OR

Over-the-Counter Use X (21 CFR §807 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)

FC

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