The GluNEO™ Lite Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Glubert Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The GluNEO™ Lite Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It 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 GluNEO™ Lite Test Strips are for use with the GluNEO™ Lite Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The GluNEO™ Lite Control Solutions are for use with the GluNEO™ Lite Meter and GluNEO™ Lite Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

The GluNEO™ Lite Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The GluNEO™ Lite 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, singleuse lancing devices. The GluNEO™ Lite 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 GluNEO™ Lite Professional Test Strips are for use with the GluNEO™ Lite Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips. ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The GluNEO™ Lite Professional Control Solutions are for use with the GluNEO™ Lite Professional Meter and GluNEOTM Lite Professional Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Device Description

The GluNEO™ Lite / GluNEO™ Lite Professional Blood Glucose Monitoring System consists of a meter, test strips and control solutions (level 2 and level 3), a lancing device and sterile lancets. With the GluNEOTM Lite Professional Blood Glucose Monitoring System, only auto-disabling or single use lancing device must be used. This 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

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the GluNEO™ Lite / GluNEO™ Lite Professional Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to meeting the requirements of ISO 15197:2003 for performance. While the specific numerical acceptance criteria from ISO 15197:2003 are not explicitly listed in the summary, they are a well-established international standard for blood glucose monitoring systems. For the purpose of this response, I will state the criteria as per ISO 15197:2003 and then interpret the "reported device performance" based on the general statement in the document that the device "passed all of the tests based on pre-determined Pass/Fail criteria."

Implicit Acceptance Criteria (based on ISO 15197:2003 for glucose meters) and Reported Device Performance:

Acceptance Criteria (ISO 15197:2003 - general, actual ranges depend on glucose concentration)	Reported Device Performance (as stated or implied)
Accuracy (System Accuracy):	Met (Device passed all tests against pre-determined Pass/Fail criteria.)
- For glucose concentrations < 4.2 mmol/L (75 mg/dL): ≥ 95% of results within ± 0.83 mmol/L (± 15 mg/dL) of reference method.	The summary states the device passed all tests based on pre-determined Pass/Fail criteria, implying these accuracy metrics were met. The specific percentages or deviations are not provided.
- For glucose concentrations ≥ 4.2 mmol/L (75 mg/dL): ≥ 95% of results within ± 20% of reference method.
Precision (Repeatability/Intermediate Precision): (Typically assessed through coefficients of variation (CV%) at various glucose levels)	Met (Device passed all tests against pre-determined Pass/Fail criteria.)
Interfering Substances: (No significant interference from common substances)	Met (Implied by passing all tests, as interference studies are part of ISO 15197.)
Hematocrit Effects: (Accurate readings across a specified hematocrit range)	Met (Implied by passing all tests.)
Temperature and Humidity Effects: (Maintained performance across specified environmental conditions)	Met (Implied by passing all tests.)
Usability/User Performance: (Demonstrated acceptable results when used by lay-users)	Met (Clinical evaluation included user performance.)

Note: The 510(k) summary does not provide specific numerical results (e.g., percentages of results within limits) but rather a high-level statement that the device "passed all of the tests based on pre-determined Pass/Fail criteria" in accordance with ISO 15197:2003.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical evaluation included method comparison, matrix comparison. user performance and alternative-site blood glucose measurement." Standard practice for ISO 15197 usually involves a minimum number of subjects (e.g., ~100 subjects for system accuracy, with capillary and venous blood samples per subject). However, the exact number used in this specific study is not provided.
Data Provenance: Not explicitly stated. The applicant is Infopia Co., Ltd. from the Republic of Korea, but the location where the clinical evaluations were conducted is not mentioned. It is common for such studies to be conducted in a sponsor's home country or in clinical sites that meet regulatory requirements.
Retrospective or Prospective: Not explicitly stated. Clinical evaluations, especially user performance and method comparison studies, are typically prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the summary. For blood glucose monitoring systems, the "ground truth" (reference method) is typically established using a highly accurate laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar) which is operated and calibrated by trained laboratory personnel, rather than "experts" in the sense of clinicians establishing a diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of a blood glucose monitoring system's accuracy study. Adjudication methods (like 2+1, 3+1, etc.) are typically used in studies where human readers interpret medical images or clinical data, and their disagreements need to be resolved to establish ground truth or evaluate diagnostic performance. For glucose meters, the reference value is determined by a precise laboratory instrument.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. MRMC studies are designed to compare the diagnostic performance of different readers (human or AI) across multiple cases, often in radiology or pathology. This submission concerns the accuracy and performance of a blood glucose meter, which is a quantitative measurement device, not an interpretive diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, a standalone performance evaluation was done. The "Performance Data" section states, "Non-clinical performance evaluations were conducted to establish the performance, functionality and reliability characteristics of the GluNEO™ Lite / GluNEO™ Lite Professional Blood Glucose Monitoring System." This refers to evaluating the device itself (meter and strips) against reference methods in a laboratory setting, independent of human user interaction for measuring accuracy. Additionally, "Clinical evaluation included method comparison" directly assesses the device's numerical output against a reference method. The "user performance" study then evaluates the device's performance when used by humans.

7. The Type of Ground Truth Used

The ground truth used would be a laboratory reference method for glucose measurement (e.g., a hexokinase-based enzymatic method on a high-precision analyzer like a YSI analyzer). The summary states "method comparison," which implies comparing the device's readings against such a reference method.

8. The Sample Size for the Training Set

This information is not applicable/provided. Blood glucose monitoring systems like the GluNEO™ Lite typically do not use a "training set" in the machine learning sense. Their calibration and algorithms are established during the manufacturing and development phase using controlled experiments and chemical principles, not through machine learning on large datasets that require separate training and test sets.

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

This information is not applicable/provided for the reasons stated in point 8. The calibration of the device's algorithm (how it converts the electrical signal from the test strip into a glucose reading) is established during development, likely using precisely prepared glucose solutions and reference measurement techniques to define the relationship between the electrical signal and glucose concentration.

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: 11/25/2013

1. Applicant / Submitter:

Infopia Co., Ltd 891. Hogye-Dong. Dongan-Gu, Anyang, Kyunggi, Republic of Korea 431-080

Phone +82 31 460 0300 Fax +82 31 460 0401

2. Submission Correspondent:

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

DEC 0 5 2013

3. Device:

· Device's Trade Name:
· Device's Common Name:
· Device's Classification Name:

GluNEOTM Lite Glucose Monitoring System GluNEO™ Lite Professional Glucose Monitoring System

Blood Glucose Test System Quality control material (assayed and unassayed)

Glucose Dehydrogenase Single (specified) analyte controls Calculator/data processing module for clinical use

Classification Regulation: 21CFR 862.1345 21CFR 862.1660
· Classification Product Code: LFR, NBW, JJX

Infopia Co., Ltd.

510k summary Page 1٠٠٠٠ بَرَبَنِ 1

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4. Predicate Device:

GluNEO™ / GluNEO™ Professional Blood Glucose Monitoring System (K13018) by Infopia Co., Ltd.

5. Description:

6. Indications for use:

GluNEO™ Lite Blood Glucose Monitoring System

The GluNEO™ Lite Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The GluNEO™M Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

GluNEOTM Lite Professional Blood Glucose Monitoring System

The GluNEO™ Lite Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The GluNEO™ Lite 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 GluNEO™ Lite Professional Blood Glucose Monitoring System should not be used for

Infopia Co., Ltd.

510k summary Page 2

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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 GluNEOTM Lite Professional Test Strips are for use with the GluNEO™ Lite Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips. ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

7. Technological Characteristics:

The GluNEOTM Lite / GluNEOTM Lite Professional Blood Glucose Monitoring System has the same fundamental scientific technology as the predicate device and has similar performance specifications and features.

8. Performance Data:

The performance tests for the GluNEOTM Lite / GluNEOTM Lite Professional Blood Glucose Monitoring System were performed in accordance with ISO 15197:2003 and some other international standards. Clinical evaluation included method comparison, matrix comparison. user performance and alternative-site blood glucose measurement. Non-clinical performance evaluations were conducted to establish the performance, functionality and reliability characteristics of the GluNEO™ Lite / GluNEO™ Lite Professional Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria.

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 cvcles designed to simulate 3 years of device use.

9. Conclusions:

Infopia Co., Ltd. concludes that the GluNEO™ Lite / GluNEOT™ Lite Professional Blood Glucose Monitoring System is safe and effective and also substantially equivalent to the predicate device. GluNEOTM Lite / GluNEOTM Lite Professional Blood Glucose Monitoring System (K130181) by Infopia Co., Ltd.

Infopia Co., Ltd.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Public Health Service

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

December 5, 2013

INFOPIA CO., LTD C/O PRISCILLA CHUNG 1515 E KATELLA AVE UNIT 2115 ANAHEIM CA 92805

Re: K132966

Trade/Device Name: GluNEO Lite Blood Glucose Monitoring System Gluneo Lite Professional Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: September 13, 2013 Received: September 20, 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, listing 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132966

Device Name

GluNEO™ Lite Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

tavce Beck

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132966

Device Name

Device Name: GluNEO™ Lite Professional Blood Glucose Monitoring System

Indications for Use (Describe)

The GluNEO™ Lite Professional Test Strips are for use with the GluNEO™ Lite Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Stavce Beck

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.