GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM

K051285 · Infopia Co, Ltd. · CGA · Aug 2, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051285
• Device Name: GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Infopia Co, Ltd.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Aug 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GLUCOLAB™ Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings, including physician's office laboratories and point of care sites. The GLUCOLAB™ System provides plasma-equivalent results. The GLUCOLAB™ System is not intended to be used with neonatal blood samples. The GLUCOLAB™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh. GlucoLab™ control is used with GlucoLab™ Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly. It is very important that you do control solution tests routinely to make sure you are getting accurate results. Control Solutions are sold separately.

Device Story

GLUCOLAB™ is an in vitro diagnostic blood glucose monitoring system; utilizes electrochemical test strips; measures glucose concentration in whole blood samples; intended for home and clinical use; operated by patients or healthcare professionals; provides plasma-equivalent glucose results; aids in diabetes management; supports fingertip and alternate site testing (forearm, upper arm, palm, calf, thigh); includes control solution for system verification.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to predicate devices.

Technological Characteristics

Electrochemical glucose monitoring system; utilizes dehydrogenase glucose enzyme reaction on test strips; generates electrical current proportional to glucose concentration; supports fingertip and alternate site testing; standalone meter device.

Indications for Use

Indicated for quantitative blood glucose monitoring in patients with diabetes in home, clinical, and point-of-care settings. Contraindicated for use with neonatal blood samples.

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

• OneTouch® Ultra® (K024194)
• SURESTEP® (K984261)
• Accu-Chek Advantage (K021513)

Submission Summary (Full Text)

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Infopia, Co., Ltd.

510(k) for In Vitro Diagnostic Device

KOS/28)

#### 510(k) SUMMARY (As required by 21.CFR.807.92) According to the requirements of 21 CFR.807.92, the following Introduction: information provides sufficient data to understand the basis for a determination of substantial equivalence. Infopia Co., Ltd. Submitted By: No. 1603, Dongil Technotown A bldg., 889-3 Kwanyang2-dong, Dongan-gu, Anyang Kyunggi, 431-716 Korea Phone: [phone] Fax: [phone] Byeong Woo, Bae Contact Person: Phone: [phone] Fax: [phone] Date Summary, Prepared: May 16, 2005 Propriety Name: GLUCOLABTM Device Name: Common Name: Blood Glucose Test System Classification Name: Class II, 862.1345 Glucose Blood Tester Predicate Device: We claim substantial equivalence to the LifeScan, Inc., OneTouch® Ultra®. Device GLUCOLAB™ Monitor is an in vitro diagnostic device Description: The designed for measuring the concentration of glucose in whole blood, which is used with the GLUCOLAB™ Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result. The GLUCOLABTM Diabetes Monitoring System is used for the Intended Use: quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. GLUCOLABTM System is for

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### Infopia, Co., Ltd. 510(k) for In Vitro Diagnostic Device

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## 510(k) Summary, Continued

| | testing outside the body (in vitro diagnostic use only). Testing<br>sites include the traditional fingertip testing along with alternate<br>site testing on the arm, palm, and thigh giving it an attractive,<br>nearly painless alternative to the more painful fingertip site. . |
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| Comparison to<br>Predicate Device: | The Infopia Co., Ltd. GLUCOLAB™ Module is substantially<br>equivalent to the other products in commercial distribution<br>intended for similar use. The most notable, it is substantially<br>equivalent to the currently marketed item, the OneTouch® Ultra®<br>by LifeScan, Inc. |
| Conclusion: | The GLUCOLAB™ Blood Glucose Monitoring System is<br>substantially equivalent to the following predicate devices:<br>K024194 – LifeScan, Inc. OneTouch® Ultra®<br>K984261 – LifeScan, Inc. SURESTEP®<br>K021513 – Roche Diagnostics Corp. Accu-Chek Advantage |

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AUG 2 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Infopia Co., Ltd. C/O Edward Letko American Healthcare, Inc. 304 Park Avenue South Suite 218 New York, NY 10010

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Re: k051285

Trade/Device Name: Glucolab™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: May 16, 2005 Received: May 17, 2005

Dear Mr. Letko:

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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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,

Carol C. Benam

Carol C. Benson, M.A. Acting 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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### Infopia, Co., Ltd. 510(k) for In Vitro Diagnostic Device

# Indications for Use

K651285 510(k) Number:

Device Name: GLUCOLAB™

The GLUCOLAB™ Diabetes Monitoring System is used for the Indications For Use: Indications for ose. - The Occose level in whole blood as an aid in monitoring the quartitative "measurent in the home and in clinical settings., including physician's office laboratories and point of care sites . The GLUCOLAB™ System provides plasmaonlice laboratories and point of care System is not intended to be used with neonatal blood equivalent Tesalla. The OEM System is for testing outside the body (in vitro diagnostic use only). Samples. The GEOOOE.ID - Oyclorial is top tosting along with alternate site testing on the forearm, upper arm, palm, calf and thigh.

GlucoLab™ control is used with GlucoLab™ Brand System to check that the meter and test strips Oldcorab - online is a system and that you are performing the test correctly. It is very are working together as a system and that you are getting accurate results.

Control Solutions are sold separately

Prescription Use (Part 21 CFR 801 Subpart D)

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Over-The-Counter Use X (21 CFR 807 Subpart C)

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

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ffice of In Vitro Diagnostic Device valuation and Safety

10(k) 051285