GLUCOPACK

K052469 · Healthpia America Corp. · NBW · Jun 5, 2006 · Clinical Chemistry

Device Facts

• Record ID: K052469
• Device Name: GLUCOPACK
• Applicant: Healthpia America Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GlucoPack™ 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. GlucoPack™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertips only.

Device Story

GlucoPack™ is a blood glucose monitoring system consisting of a meter and test strips. It measures glucose levels in whole blood samples obtained from the fingertip. The device is intended for use by patients with diabetes at home or by healthcare professionals in clinical settings to monitor diabetes management effectiveness. The system performs in vitro diagnostic testing outside the body. Users apply a blood sample to the test strip, which is inserted into the meter; the meter processes the sample to provide a quantitative glucose reading. This output allows patients and clinicians to assess glycemic control and adjust diabetes management strategies accordingly.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

In vitro diagnostic blood glucose monitoring system. Uses test strips for whole blood glucose measurement. Class II device, product codes NBW and CGA. Regulation 21 CFR 862.1345.

Indications for Use

Indicated for quantitative blood glucose measurement in patients with diabetes mellitus. For home (OTC) or clinical use. Not for use on neonates. Testing site: fingertip.

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)

Submission Summary (Full Text)

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K052.469

| | 510(k) SUMMARY<br>(As required by 21.CFR.807.92) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Introduction: | According to the requirements of 21 CFR.807.92, the following<br>information provides sufficient data to understand the basis for a<br>determination of substantial equivalence. |
| Submitted By: | Healthpia America Corp.<br>211 Warren Street, #209<br>Newark, NJ 07103 |
| Contact Person: | Steven Kim<br>Phone: [phone]<br>Fax: [phone]<br>JUN - 5 2006 |
| Date Summary,<br>Prepared: | February 16th, 2006 |
| Device Name: | Propriety Name: GlucoPack™<br>Common Name: Blood Glucose Test System<br>Classification Name: Class II, 862.1345 Glucose Blood Tester |
| Predicate Device: | We claim substantial equivalence to the LifeScan, Inc.,<br>OneTouch® Ultra®, EasyGluco™ |
| Device<br>Description: | The GlucoPack™ Meter device is used along with the<br>GlucoPack™ Test Strip to measure the glucose level in whole<br>blood. |
| Intended Use: | The GlucoPack™ Diabetes Monitoring System is used for the<br>quantitative measurement of glucose level in whole blood as an aid<br>in monitoring the effectiveness of diabetes management in the<br>home and in clinical settings. GlucoPack™ System is for testing<br>outside the body (in vitro diagnostic use only). Testing sites<br>include the traditional fingertips only. |
| Comparison to<br>Predicate Device: | The Healthpia Corp. GlucoPack™ 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. |

:

6/1/2006

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## Healthpia America Corp.

510(k) for In Vitro Diagnostic Device

| Conclusion: | | The FREEDOM™ Blood Glucose Monitoring System is | |
|-------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--|
| | substantially equivalent to the following predicate devices:<br>K024194 - LifeScan, Inc. OneTouch® Ultra® | | |
| | | | |
| | K984261 -- LifeScan, Inc. SURESTEP® | | |
| | | K021513 – Roche Diagnostics Corp. Accu-Chek Advantage | |
| | | | |

·

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUN - 5 2006

Mr. Steven Kim President HealthPia America Corp. 211 Warren Street, # 209 Newark, NJ 07103

Re: k052469

Trade/Device Name: GlucoPack Regulation Number: 21 CFR& 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: May 24, 2006 Received: May 24, 2006

Dear Mr. Steven 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, 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,

Alberto Gutierrez, Ph.D.

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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# Indications for Use

510(k) Number:K052469

Device Name: GlucoPack™

Indications For Use: The GlucoPack Diabetes Monitoring System is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates.

Prescription Use_X (Part 21 CFR 801 Subpart D)

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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)

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Carol C Benson
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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

ZIC(K) K052469

Confidential Healthpia America Corp. Page 3

4/11/2006