The Element ™ plus Blood Glucose Monitoring System is for the quantitative measurement of glucose in capillary whole blood taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. Element ™ plus Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Element "M plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Element ™ plus 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 in the management of diabetes. Alternative site Testing (ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh) should be done during steady- state times when glucose is not changing rapidly.

The Element Plus Test strip are for use with the Element Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in capillary whole blood samples drawn from ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

This meter contains some speaking functions but has not been validated for use by the visually impaired.

Device Description

Element ™ plus Blood Glucose Monitoring System is comprised of test meter, test strip and control solutions. Element "" plus blood glucose test meter is substantially identical with the predicate device (Evolution "M: K072369). The minor difference is that Element "M plus test meter has voice function, which Evolution "" test meter does not have. The voice function can be used as an aid for the users to hear the test results, setting conditions and warning messages. This added function is intended to aid users' convenience.

Element 1 1 plus blood glucose test strip is identical with the predicate device (Evolution 1M. K072369) except the cover design of the test strip. Element "1" plus glucose control solutions are also exactly same as Evolution "M control solutions.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Element™ plus Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative or numerical format, nor does it provide specific reported device performance metrics (e.g., accuracy percentages, bias, precision values).

Instead, the document makes a general statement of equivalence:

Acceptance Criteria Category	Reported Device Performance
Clinical Performance	"Test results showed substantial equivalence."
Non-clinical Performance	"The device passed all of the tests based on pre-determined Pass/Fail criteria."
Disinfection Studies	"CaviWipes™ Disinfecting Towelettes... was validated demonstrating complete inactivation of live virus for 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 lancing device after 1,095 cleaning/disinfection cycles designed to simulate 3 years of device use."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Test Set: Not explicitly stated. The document only mentions "clinical performance evaluation using the Element™ plus Blood Glucose Monitoring System components were conducted for purpose of validating the consumer use for the user and the professional accuracy."
Data Provenance: Not explicitly stated. There is no mention of country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The general nature of the "substantial equivalence" statement for clinical performance suggests that a direct evaluation against a clinical ground truth might not have been performed in the same way an AI-driven diagnostic would be evaluated. For a blood glucose monitoring system, the ground truth is typically a laboratory reference method.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a blood glucose monitoring system where results are quantitative and compared against a reference method, an adjudication method for experts (like 2+1 or 3+1) is typically not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done?: No, an MRMC comparative effectiveness study was not done.
Effect Size (AI vs. without AI assistance): Not applicable, as this is a standalone device without an AI assistance component for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance evaluation was conducted for the device itself. The clinical performance evaluation and non-clinical verification/validation activities described relate to the device's inherent performance.

7. Type of Ground Truth Used

While not explicitly stated as "ground truth," for blood glucose monitoring systems, the reference standard is typically a laboratory reference method (e.g., YSI analyzer) for glucose measurement. The clinical evaluation would compare the device's readings against this reference method.

8. Sample Size for the Training Set

This information is not provided. Blood glucose monitoring systems are typically engineered devices with established biochemical principles, not machine learning algorithms that require a "training set" in the common sense (i.e., for model training). Their development involves calibration and validation, but not typically a "training set" for AI.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable in the context of device development for a blood glucose monitoring system, as it's not an AI/ML-driven device that requires a training set and associated ground truth for model development.

Summary

{0}------------------------------------------------

NOV - 4 2

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: 09/08/2011

Submission Sponsor

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

1. Submission Correspondent
  LK Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Chung Phone: 714-844-2612 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com

3. Device

· Trade Name: Element™ plus Blood Glucose Monitoring System (IGM-0021B)
· Classification Name: Glucose test system, Quality control material (assayed and unassayed)
· Classification regulation: 21 CFR Part 862.1345, 21 CFR Part 862.1660
· Product Code: NBW, CGA, JJX
1. Predicate Device:

Evolution "M Blood Glucose Test System (K072369), Infopia Co., Ltd.

1. Description:
  Element ™ plus Blood Glucose Monitoring System is comprised of test meter, test strip and control solutions. Element "" plus blood glucose test meter is substantially identical with the predicate device (Evolution "M: K072369). The minor difference is that Element "M plus test meter has voice function, which Evolution "" test meter does not have. The voice function can be used as an aid for the users to hear the test results, setting conditions and warning messages. This added function is intended to aid users' convenience.

Element 1 1 plus blood glucose test strip is identical with the predicate device (Evolution 1M. K072369) except the cover design of the test strip. Element "1" plus glucose control solutions are

510(k) Submission

{1}------------------------------------------------

also exactly same as Evolution "M control solutions.

Indications for use:

The Element™ plus Blood Glucose Monitoring System is for the quantitative measurement of glucose in capillary whole blood taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. Element™ plus Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Element™ plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Element™ plus 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 in the management of diabetes. Alternative site Testing (ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh) should be done during steady- state times when glucose is not changing rapidly.

This meter contains some speaking functions but has not been validated for use by the visually impaired.

1. Comparison to the Cleared Device
  The modified device has the same technological characteristics as the current legally marketed predicate device, Evolution TM (K072369).

8. Performance Data

Clinical: The clinical performance evaluation using the Element "M plus Blood Glucose Monitoring System components were conducted for purpose of validating the consumer use for the user and the professional accuracy. Test results showed substantial equivalence.

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

Disinfection Studies: CaviWipes™ Disinfecting Towelettes (EPA Reg. No: 46781-8) was validated demonstrating complete inactivation of live virus for 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 lancing device after 1,095 cleaning/disinfection cycles designed to simulate 3 years of device use.

{2}------------------------------------------------

9. Conclusion

The conclusion drawn from the clinical and nonclinical tests is that the Element ™ plus Blood Glucose Monitoring System is as safe, as effective and performs as well as the legally marketed predicate device, the Evolution TM (K072369).

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around an emblem. The emblem is a stylized representation of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Image /page/3/Picture/4 description: The image shows a date, "NOV 04 2011". The date is written in a simple, sans-serif font. The letters and numbers are bolded and evenly spaced. The image appears to be a close-up of the date.

Infopia Co., Ltd c/o Priscilla Chung LK Consulting Group 951 Starbuck St. Unit J Fullerton, CA 92833 US

K103021 Re:

Trade Name: Element plus Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW. CGA Dated: October 4, 2011 Received: October 7, 2011

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, 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{4}------------------------------------------------

Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please noase the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indication for Use

510(k) Number (if known): K103021

Device Name: Element TM plus Blood Glucose Monitoring System

(For single patient-home use)

Indication For Use:

The Element ™ plus Blood Glucose Monitoring System is for the quantitative measurement of glucose in capillary whole blood taken from the fingertip, ventral palm, dorsal hand, upper arm, forcarm, calf and/or thigh. Element ™ plus Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Element "M plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Element ™ plus 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 in the management of diabetes. Alternative site Testing (ventral palm, dorsal hand, upper arm, calf and/or thigh) should be done during steady - state times when glucose is not changing rapidly.

The Element The plus Test Strips are for use with the Element™ plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

This meter contains some speaking functions but has not been validated for use by the visually impaired.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

C. Davis, Jr.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K10302 |

510(k) Submission

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.