(270 days)
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.
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.
The GlucoPack™ Meter device is used along with the GlucoPack™ Test Strip to measure the glucose level in whole blood.
The provided document describes the GlucoPack™ Blood Glucose Test System (K052469) and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods.
This 510(k) summary focuses on general device description, intended use, and comparison to predicate devices for substantial equivalence determination. Performance data, if present in the original submission, is not included in this extract.
Therefore, I cannot provide the requested information based on the given input. The requested details typically reside in the performance data section of a 510(k) submission, which is absent here.
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K052.469
| 510(k) SUMMARY(As required by 21.CFR.807.92) | |
|---|---|
| Introduction: | According to the requirements of 21 CFR.807.92, the followinginformation provides sufficient data to understand the basis for adetermination of substantial equivalence. |
| Submitted By: | Healthpia America Corp.211 Warren Street, #209Newark, NJ 07103 |
| Contact Person: | Steven KimPhone: 973-286-7676Fax: 212-202-5173JUN - 5 2006 |
| Date Summary,Prepared: | February 16th, 2006 |
| Device Name: | Propriety Name: GlucoPack™Common Name: Blood Glucose Test SystemClassification Name: Class II, 862.1345 Glucose Blood Tester |
| Predicate Device: | We claim substantial equivalence to the LifeScan, Inc.,OneTouch® Ultra®, EasyGluco™ |
| DeviceDescription: | The GlucoPack™ Meter device is used along with theGlucoPack™ Test Strip to measure the glucose level in wholeblood. |
| Intended Use: | The GlucoPack™ Diabetes Monitoring System is used for thequantitative measurement of glucose level in whole blood as an aidin monitoring the effectiveness of diabetes management in thehome and in clinical settings. GlucoPack™ System is for testingoutside the body (in vitro diagnostic use only). Testing sitesinclude the traditional fingertips only. |
| Comparison toPredicate Device: | The Healthpia Corp. GlucoPack™ Module is substantiallyequivalent to the other products in commercial distributionintended for similar use. The most notable, it is substantiallyequivalent to the currently marketed item, the OneTouch® Ultra®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: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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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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
ZIC(K) K052469
Confidential Healthpia America Corp. Page 3
4/11/2006
§ 862.1345 Glucose test system.
(a)
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.(b)
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.