The Healthpro™ Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The Healthpro™ Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The Healthpro™ Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Healthpro™ Professional test strips are for use with the Healthpro™ Professional meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The Healthpro™ Professional Control Solutions are for use with the Healthpro™ Professional meter and Healthpro™ Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Prescription Use (Part 21CFR 801Subpart D)

Device Description

The Healthpro™ Professional Blood Glucose System consists of a meter, test strips and control solutions (Level 1, Level 2 and level 3). The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

AI/ML Overview

The provided text is a 510(k) summary for the Healthpro™ Professional Blood Glucose Monitoring System. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria.

The section "8. Performance Data" states: "Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the Healthpro™ Professional Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria."

This statement confirms that performance data exists, and the device passed tests based on criteria, but it does not provide the actual acceptance criteria or the specific results of those tests. Therefore, I cannot generate the requested table and detailed study information based on the input text.

To answer your request, the provided document is missing the following crucial information:

Specific Acceptance Criteria: What were the "pre-determined Pass/Fail criteria"? For a blood glucose meter, this would typically involve accuracy metrics like ISO 15197 standards (e.g., percentage of results within a certain range of a reference method).
Reported Device Performance: The actual measured accuracy, precision, or other performance statistics obtained during the validation studies.
Study Design Details: Sample size, data provenance, ground truth establishment methods, number/qualifications of experts, adjudication methods for any accuracy studies mentioned.
Training Set Details: Sample size and ground truth establishment for any training data (though for a blood glucose meter, the "training" would be more about calibration and internal algorithms, not typically a machine learning training set in the AI sense).

Without these details, I cannot fulfill your request for a table of acceptance criteria and proven performance, nor can I elaborate on the study specifics.

Summary

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510(k) Summary

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 09/06/2013

Applicant / Submitter

Infopia Co., Ltd. 891 Hogye-dong, Dongan-Gu, Anyang, Kyunggi, 431-080. Korea Phone: +82-31-460-0300 Fax: +82-31-460-0401

2. Submission Correspondent

LK Consulting Group USA, Inc. 1515 E Katella Ave. Unit 2115. Anaheim, CA 92805 Priscilla Chung Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

· Trade Name: Healthpro™ Professional Blood Glucose System
· Classification Name: Glucose test system. Quality control material (assayed and unassaved)
· Classification regulation: 21 CFR Part 862.1345, 21 CFR Part 862.1660
· Product Code: NBW, CGA, JJX
1. Predicate Device:

Healthpro TM Blood Glucose Test System (K113192), Infopia Co., Ltd.

1. Description:
  The Healthpro™ Professional Blood Glucose System consists of a meter, test strips and control solutions (Level 1, Level 2 and level 3). The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
1. Indications for use:
  The Healthpro™ Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The Healthpro™ Professional Blood Glucose Monitoring System is intended for testing outside

510(k) Submission

510(k) summary . 1 / 2 page

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the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The Healthpro™ Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

Comparison to the Cleared Device

The modifications are adding prescription use claim to the indications of use, adding a Patient ID function and modifying graphic design of the strip cover. With the added ID function, the user can save a test result with a unique ID number assigned for each patient.

Other than these modifications, the modified meter has the following similarities to the cleared device:

· has the same intended use,
· uses the same operating principle,
· adopts the same use environment and calibration method.

8. Performance Data

Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the Healthpro™ Professional Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria.

Disinfection Study: Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of live virus of use with the meter and the reusable lancing device. There was also no change in performance or in the external materials of the meter and the lancing device after 10,980 cleaning/disinfection cycles designed to simulate 3 years of device use.

Conclusion

The conclusion drawn from the validation tests is that the Healthpro™ Professional Blood Glucose Monitoring System is as safe, as effective and performs as well as the legally marketed predicate device, Healthpro TM Blood Glucose Test System (K113192).

510(k) Submission

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, placed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. The logo is printed in black ink.

Public Health Service

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

December 12, 2013

INFOPIA CO., LTD C/O PRISCILLA CHUNG LK CONSULTING GROUP USA INC 1515 E KATELLA AVE UNIT 2115 ANAHEIM CA 92805

Re: K132862

Trade/Device Name: Healthpro Professional Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: November 6, 2013 Received: November 12, 2013

Dear Ms. Chung:

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 Parts 801 and 809); 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-Ms. Chung

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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Sincerely yours,

Carol Benson -S 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

510{k) Number: K132862

Healthpro™ Professional Blood Glucose Monitoring System Device Name:

Indication for use:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Healthpro™ Professional Control Solutions are for use with the Healthpro 14 Professional meter and Healthpro™ Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

AND/OR

Prescription Use (Part 21CFR 801Subpart D)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OJR)

Stayce Beck

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)

Regulation Number and Section

§ 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.