LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM

K102751 · Ceragem Medisys, Inc. · NBW · Feb 11, 2013 · Clinical Chemistry

Device Facts

• Record ID: K102751
• Device Name: LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Ceragem Medisys, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The LabonaCheck® Gluppy Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The LabonaCheck® Gluppy Blood Glucose Test Strips are for use with the LabonaCheck® Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LabonaCheck® Gluppy Control Solution is for use with the LabonaCheck® Gluppy Blood Glucose Monitoring System as a quality control check to verify that the meter and test strips are working together properly.

Device Story

System measures glucose in fresh capillary whole blood; sample applied to test strip; blood drawn into reaction zone; reaction between glucose and glucose oxidase enzyme occurs. Device uses amperometry to quantify glucose levels. Used at home by patients with diabetes for self-monitoring. System includes test meter, test strips, code key, lancing device, lancets, battery, and carrying case. Output displayed on meter screen; helps patients track glucose levels and monitor diabetes control effectiveness. Control solution verifies system performance.

Clinical Evidence

User performance study (n=200) and system accuracy study (n=220, including 20 contrived samples) compared device results to YSI 2300 reference analyzer. Accuracy: 100% of results within ±15 mg/dL for glucose <75 mg/dL and 100% within ±20% for glucose ≥75 mg/dL. Linear regression (user vs. YSI) showed r=0.9922. Bench testing confirmed precision (CV 2.2-4.4%), linearity (20-600 mg/dL), and interference resistance.

Technological Characteristics

Amperometric glucose monitoring system. Uses Glucose Oxidase (Aspergillus niger) enzyme and Potassium ferricyanide mediator. Noble metal electrode. Powered by CR2032 battery. Test range 20-600 mg/dL. Temperature range 50-104°F. Hematocrit range 20-60%.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for self-testing by people with diabetes to monitor glycemic control. Contraindicated for neonatal use, diabetes screening/diagnosis, and use on critically ill, shock, 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

• RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K081451)

Submission Summary (Full Text)

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K102751

### FEB 1 1 2013

CERAGEM Medisys Inc. www.ceragemmedisys.com

### 510(k) Summary

In accordance with the requirements of 21 CFR.807.92, the following information about 510(k) safety and effectiveness is being submitted.

CERAGEM

MEDISYS

Submitter CERAGEM Medisys Inc. #103-703, SK Ventium, 522 Dangjeong-dong, Gunpo-si, Gyeonggi-do, 435-776, Republic of Korea Phone : [phone] Fax : [phone] Contact Person: Mi - Suk Park Date Prepared 2. February 11, 2013 3. Device Name Common name : LabonaCheck Gluppy Blood Glucose Monitoring System LabonaCheck Gluppy Control Solution Classification : Class II (Regulation: 21 CFR § 862.1345) Class I (Regulation: 21 CFR & 862.1660) Product Codes : NBW(Blood Glucose Test System, Over the Counter), CGA 11X Predicate Device 4. LabonaCheck® Gluppy Blood Glucose Monitoring System is substantially equivalent to The RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM described as below. (1) Device Name: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, (2) Model: GM 100 (3) Manufacturer: BIONIME CORPORATION (4) 510(K) Number: K081451 Device Description 5. The system consists of Test Meter, Test Strips, Code key, Lancing Device, lancets, 3V battery and Carrying Case.

The system measures the amount of glucose (sugar) in whole blood. Blood is applied to the

Total 3 pages

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absorbent hole of the test strip and automatically drawn into the reaction zone where reaction between reagent and glucose occurs.

6. Indication for use

MEDISYS

CERAGEN

The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The LabonaCheck® Gluppy Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The LabonaCheck® Gluppy Blood Glucose Test Strips are for use with the LabonaCheck® Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

The LabonaCheck® Gluppy Control Solution is for use with the LabonaCheck® Gluppy Blood Glucose Monitoring System as a quality control check to verify that the meter and test strips are working together properly.

| Comparison | | |
|-------------------|----------------------------------------|----------------------------------------|
| Item | Device | Predicate |
| Device Name | LabonaCheck® Gluppy | RIGHTEST GM100 |
| Similarities | | |
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase<br>(Aspergillus niger) | Glucose Oxidase<br>(Aspergillus niger) |
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
| Test range | 20~600 mg/dL | 20~600 mg/dL |
| Temperature range | 50~104°F<br>10~40°C | 50~104°F<br>10~40°C |

Comparison to Predicate Device ` 7.

Total 3 pages

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#### CERAGEM Medisys Inc. www.ceragemmedisys.com

| Sample Volume | 1.0 uL | 1.4 uL |
|-----------------------------|------------------------------------------------------|-----------------------------------------------------|
| Humidity range | Below 80% | 10~90% |
| Electrode | Noble metal electrode | Noble metal electrode |
| Warranty(Test Meter) | 3 years | 3 years |
| Power(Battery) | CR2032 | CR2032 |
| Differences | | |
| Open use time (Test Strips) | 4 months | 3 months |
| Coding | Code Key | No coding |
| Test Time | 5 second | 8 second |
| Hematocrit range | 20~60% | 30-55% |
| Memory | 500 blood glucose test results<br>with date and time | 10 blood glucose test results<br>with date and time |

#### Conclusion

As shown in the comparison table, the LabonaCheck® Gluppy Blood Glucose Monitoring System and the RIGHTEST GM100 have the same detection method, test range, temperature range, electrode and batteries. Furthermore, the LabonaCheck® Gluppy Blood Glucose Monitoring System also uses the same enzyme and mediator as the RIGHTEST GM100. To sum up the similarities, the LabonaCheck® Gluppy Blood Glucose Monitoring System is similar with the predicate device because most of the specifications deciding the characteristics of the device are the same. In conclusion, despite the differences such as open use time, coding, test time, etc. the LabonaCheck® Gluppy Blood Glucose Monitoring System is substantially equivalent to the predicate device.

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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 & Human Services. The logo consists of a stylized human figure with three arms or branches extending upwards, representing health and well-being. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the figure.

Public Health Service

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

February 11, 2013

Ceragem Medisys Inc. c/o Grace Kim Ceragem International Inc. 3699 Wilshire Blvd., Suite 930 Los Angeles, CA 90010

Re: k102751

Trade/Device Name: LabonaCheck Gluppy Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: January 28, 2013 Received: February 07, 2013

#### Dear Ms. Kim:

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. Iisting 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 Part 801); 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— Kim Grace

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 C. Benson 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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## Indications for Use Form

510(k) Number (if known): k102751

Device Name: LabonaCheck Gluppy Blood Glucose Monitoring System

Indications for Use:

The LabonaCheck Gluppy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LabonaCheck Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The LabonaCheck Gluppy Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The LabonaCheck Gluppy Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.

The LabonaCheck Gluppy Blood Glucose Test Strips are for use with the LabonaCheck Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

The LabonaCheck Gluppy Control Solution is for use with the LabonaCheck Gluppy Blood Glucose Monitoring System as a quality control check to verify that the meter and test strips are working together properly.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _ × (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

# Katherine Serrano

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) k102751

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