The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm. The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Veri-Q self-testing MGD-1001 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 to monitor the effectiveness of diabetes control. The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The Veri-Q self-testing MGS-01 test strips are for use with the Veri-Q self-testing MGD-1001 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips. palm. or forcarm.

The Veri-Q self-testing Glucose Control Solutions are for use with the Veri-Q self-testing MGD-1001 meter and the Veri-Q self-testing MGS-01 test strips to check that the meter and test strips are working together properly and providing accurate results.

The Veri-Q plus MGD-1001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose (sugar) in fresh capillary whole blood drawn from fingertips, palm, or forearm. The Veri-Q plus MGD-1001 Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). The Veri-Q plus MGD-1001 Blood Glucose Monitoring System is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. The Veri-Q plus MGD-1001 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Veri-Q plus MGS-01 test strips are for use with the Veri-Q plus MGD-1001 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm. The Veri-Q plus Glucose Control Solutions are for use with the Veri-Q plus MGD-1001 meter and the Veri-Q plus MGS-01 test strips to check that the meter and test strips are working together properly and providing accurate results.

Device Description

The proposed Veri-Q self-testing / plus MGD-1001 Blood Glucose Monitoring System consists of a meter, test strips, control solutions (3 levels), a lancing device and sterile lancets. The blood glucose test system is an in vitro diagnostic device designed for measuring the The orded gracess in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement. The Veri-Q self-testing / plus MGD-1001 meter is a no-code meter, so the responsibility of coding has been removed from the user. Each individual test strip contains technology that allows it to automatically calibrate and code the meter once it is inserted.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Veri-Q self-testing / plus MGD-1001 Blood Glucose Monitoring System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that the device was tested in accordance with ISO 15197:2003. This standard defines the acceptance criteria for blood glucose monitoring systems. However, the specific numerical acceptance criteria and the detailed reported performance results are not explicitly provided in the given text. The summary only generally states:

"The device passed all of the tests based on pre-determined Pass/Fail criteria."

To accurately complete this table, one would need to refer to the full ISO 15197:2003 standard and the detailed performance report submitted for the 510(k). As a general reference for ISO 15197:2003, common criteria include:

Acceptance Criteria (Based on ISO 15197:2003, typical)	Reported Device Performance (Not specified in provided text)
System Accuracy (within ±15% or ±0.83 mmol/L):
- For glucose concentrations < 4.2 mmol/L (75 mg/dL)	(e.g., X% of results within ±0.83 mmol/L of reference)
- For glucose concentrations ≥ 4.2 mmol/L (75 mg/dL)	(e.g., Y% of results within ±15% of reference)
Repeatability/Precision:
- Coefficient of Variation (CV) for various glucose	(e.g., CV at low, mid, high concentrations)
levels
Intermediate Precision:
- CV across multiple days, operators, etc.	(e.g., CV at low, mid, high concentrations)
Linearity:	(e.g., demonstrates linearity across measuring range)
Interferences (e.g., hematocrit, common substances):	(e.g., no significant interference from tested substances)
Usability/Human Factors:	(e.g., passed usability studies)

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

Sample Size for Test Set: Not explicitly stated in the provided 510(k) summary. The summary mentions "Clinical evaluation" and "Non-clinical testing" but does not give the number of samples or subjects.
Data Provenance: Not specified. The submitter is MiCoBioMed Co., Ltd. from Republic of Korea, but there is no information about the country of origin of the data or whether it was retrospective or prospective.

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

Number of Experts: This is a blood glucose monitoring system. Ground truth for blood glucose is typically established using a laboratory reference method (e.g., hexokinase, glucose oxidase method on a high-precision analyzer), not by human experts. Therefore, the concept of "experts establishing ground truth" as it applies to image analysis or diagnostic interpretation by radiologists is not applicable here.
Qualifications of Experts: N/A (as explained above).

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. For blood glucose meters, the reference method provides the "ground truth," and there is no human adjudication process involved in comparing meter readings to expert consensus.

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

MRMC Study: No. This type of study (MRMC) is typically relevant for diagnostic imaging devices where human readers interpret cases. For a blood glucose monitoring system, the performance is assessed against a laboratory reference method, and improvement in human reader performance is not a relevant metric.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: For a blood glucose meter, the "standalone performance" is essentially the system accuracy and precision testing conducted. The device (meter and test strip) acts as the algorithm, providing a quantitative measurement. The clinical evaluation mentioned in the summary, which includes "method performance," falls under this category. The results are compared directly to a laboratory reference method.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for blood glucose monitoring systems is established using a laboratory reference method (e.g., YSI analyzer, hexokinase method). This method is considered the highly accurate standard against which the performance of the point-of-care device is measured.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. Blood glucose monitoring systems are generally designed and calibrated during their development (internal "training") using a set of known glucose concentrations. The 510(k) summary does not mention a separate "training set" in the context of machine learning, as this is not an AI/ML-based diagnostic imaging or pattern recognition device. The "training" would be part of the manufacturing calibration process.

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

How Ground Truth for Training Set was Established: Not applicable/Not specified. As with the test set, during the development and calibration of the device, known glucose concentrations (prepared using highly accurate reference substances or measured by laboratory reference methods) would be used to calibrate the meter and test strips. This is an engineering calibration process, not "ground truth establishment" in the AI/ML sense.

Summary

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K123007

510(k) Summary

JUN 1 9 2013

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

05/27/2013 Date: _

1. Submitter:

MiCoBioMed Co., Ltd. 55-13, Singeonji-Dong, Anseong-Si, Gyenggi-Do, 456-781, Republic of Korea Tel : +82-31-8056-5940 Fax : +82-31-8056-5518

Submission Correspondent: 2.

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

Device:

Proprietary Name:	Veri-Q self-testing MGD-1001 Blood Glucose Monitoring SystemVeri-Q plus MGD-1001 Blood Glucose Monitoring System
Common Name:	Blood Glucose Test System
Classification Name:	System, Test, Blood Glucose, Over The CounterGlucose OxidaseSingle(specified) analyte controls
Classification:	Class II, 21 CFR 862.1345
Classification Product Code:	NBW
Subsequent Product Codes	CGA, JJX

4. Predicate Device:

CareSens N(K083468) by i-SENS, Inc.

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પં Description:

6. Indications for use:

6.1 Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System

The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm. The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Veri-Q self-testing MGD-1001 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 to monitor the effectiveness of diabetes control. The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Veri-O self-testing Glucose Control Solutions are for use with the Veri-Q self-testing MGD-1001 meter and the Veri-Q self-testing MGS-01 test strips to check that the meter and test strips are working together properly and providing accurate results.

6.2 Veri-Q plus MGD-1001 Blood Glucose Monitoring System

510k summary Page 2 of 3

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The Veri-Q plus Glucose Control Solutions are for use with the Veri-Q plus MGD-1001 meter and the Veri-Q plus MGS-01 test strips to check that the meter and test strips are working together properly and providing accurate results.

7. Technological Characteristics:

The Veri-Q self-testing / plus MGD-1001 Blood Glucose Monitoring System has the same fundamental scientific technology as the predicate device. The indications for use, technology, design of glucose meter, and strips are almost the same. The major difference is that for the Veri-Q meter, non coding is required on user side but the predicate device employs autocoding method. There are also minor difference such as shelf life and memory capacity.

8. Performance Data:

The testing for the Veri-Q self-testing / plus MGD-1001 Blood Glucose Monitoring System was performed in accordance with ISO 15197:2003. Clinical evaluation included method was performous in arrormance and alternative-site blood glucose measurement. Non-clinical compulsion, asor perform were conducted to establish the performance, functionality and reliability characteristics of the Veri-Q self-testing / plus MGD-1001 Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria.

Conclusions: 9.

MiCoBioMed Co., Ltd. concludes that the Veri-Q self-testing / plus MGD-1001 Blood Glucose Monitoring System is safe and effective also, substantially equivalent to the predicate device.

510k summary Page 3 of 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, resembling a human figure or a symbol representing health and well-being. The logo is black and white.

Public Health Service

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

· June 19, 2013

MiCoBioMed Co., Ltd. C/O Priscilla Chung C/O LK Consulting Group 1515 E. Katella Ave, Unit 2115 ANAHEIM CA 92805

Re: K123007

Trade/Device Name: Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System Veri-Q plus MGD-1001 Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: May 28, 2013 Received: May 30, 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 Part 801); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.

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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Indications for Use

510(k) Number K 123007

Device Name: Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System

Indication for use:

The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm. The Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Veri-Q self-testing MGD-1001 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 to monitor the effectiveness of diabetes control. The Veri-O self-testing MGD-1001 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

Prescription Use------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21CFR801 Subpart D)	AND/OR Over-The-Counter Use(Part 21CFR807 Subpart C)
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Katherine Serrano -S

Division Sign-Off Office of In Vitro and Radiological Health Evaluation and Safety

510(k) K123007 Page I of 2

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Indications for Use

510(k) Number K 123007

Device Name: Veri-Q plus MGD-1001 Blood Glucose Monitoring System

Indication for use:

Prescription Use (Part 21CFR801 Subpart D) Over-The-Counter (Part 21CFR807 Subpart C)

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

AND/OR

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

Katherine Serrano -S

Division Sign-Off Office of In Vitro and Radiological Health Evaluation and Safety

510(k) K123007 Page 2 of 2

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.