The GlucoVitaal H1A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, thigh, or calf. The GlucoVitaal H1A Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GlucoVitaal H A 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 controls. The Gluco Vitaal H1 A Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GlucoVitaal H1A Blood Glucose Test Strips are for use with the Glood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf.

The GlucoVitaal H1A Glucose Control Solution is for use with the GlucoVitaal H1A Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

Device Description

The GlucoVitaal H1A Blood Glucose Monitoring System consists of GlucoVitaal H1A Blood Glucose Test Meter, GlucoVitaal H1A Blood Glucose Test Strips, GlucoVitaal H1A Glucose Control Solution 1 and Control Solution 2, a Lancing device. Control Solution 1 and Control Solution 2 are required but not included with the meter. Control Solution 1 and Control Solution 2 are always provided as a set.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GlucoVitaal H1A Blood Glucose Monitoring System, seeking substantial equivalence to a predicate device (CERA-CHEK 1070 Blood Glucose Monitoring System).

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a regulated performance standard. Instead, it aims to demonstrate substantial equivalence to a predicate device by comparing various specifications. The "reported device performance" is not given as numerical results against predefined criteria, but rather as statements of identical or similar specifications to the predicate device.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (GlucoVitaal H1A)
Detection Method	Amperometry (Same as Predicate)
Enzyme	Glucose dehydrogenase (FAD-GDH) (Same as Predicate)
Test Time	5 seconds (Same as Predicate)
Memory	1000 blood glucose test results with date and time (Same as Predicate)
Sample Volume	0.5 uL (Same as Predicate)
Humidity range	10-85% (Same as Predicate)
Temperature range	50-104°F (10-40°C) (Same as Predicate)
Power (Battery)	One 3-volt lithium battery (CR2032) (Same as Predicate)
Test range	20-600 mg/dL (Same as Predicate)
Level of QC	2 Levels (Control 1, Control 2) (Same as Predicate)
Dimensions	94mm(H) x 53.6(W) x 14.9mm(T) (Same as Predicate)
Weight	35g (Same as Predicate)
Hematocrit range	10-70% (Same as Predicate)
Code Setting	No code (Predicate device required a code key; candidate device has one built-in)
Language	English, Spanish and Portuguese (Predicate device only had English)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for any test set or the data provenance. It focuses on comparing specifications and features for substantial equivalence, rather than presenting a performance study with detailed results from a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The submission is for a blood glucose monitoring system, which typically relies on laboratory reference methods (e.g., YSI analyzer) for ground truth, not expert human readers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document given the nature of the device and the substantial equivalence claim. Adjudication methods are typically relevant for image-based diagnostic systems where human interpretation can vary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not applicable and not mentioned in the document. This type of study is relevant for AI-assisted diagnostic tools involving human interpretation, which is not the case for a blood glucose monitoring system.

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

While the device itself operates "standalone" in measuring glucose, the document does not describe a specific performance study in terms of an algorithm-only evaluation. Instead, it asserts that the modification of code setting (from code key to no code) would have "no effect on the performance test," implying that prior performance data (likely from the predicate device) is considered relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for any performance evaluation. However, for blood glucose monitoring systems, the ground truth is typically established using a highly accurate laboratory reference method, such as a YSI glucose analyzer.

8. The sample size for the training set

The document does not mention a training set or its sample size. This is a 510(k) submission focused on substantial equivalence to an existing device, not the development and training of a novel algorithm from scratch.

9. How the ground truth for the training set was established

Since no training set is mentioned, the method for establishing its ground truth is not provided.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked one behind the other.

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

September 30, 2014

CERAGEM MEDISYS INC. HAK-SUNG KIM 16 JEONGJA1-GIL, SEONGGEO-EUP, SEOBUK-GU, CHEONAN-SI, CHUNGCHEONGNAM-DO, 331-833 KOREA

Re: K141829

Trade/Device Name: GlucoVitaal H1A Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR, JJX Dated: September 24, 2014 Received: September 24, 2014

Dear Mr. Hak-Sung Kim:

This letter corrects our substantially equivalent letter of September 24, 2014.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809 ), please contact the Division of Industry and Consumer Education 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 Industry and Consumer Education 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.

Sincerely yours,

Courtney H.Lias -S

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

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Indications for Use

510(k) Number (if known) K141829

Device Name

GlucoVitaal H1A 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) Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the logo for CERAGEM MEDISYS. The word "CERAGEM" is in large, bold, red letters. Below that, the word "MEDISYS" is in smaller, gray letters. To the right of the words is an orange geometric shape that looks like a stylized letter C.

510(k) Summary

In accordance with the requirements of 21 CFR.807.92, the following information about 510(k) safety and effectiveness is being submitted.

1. Submitter

CERAGEM Medisys Inc.

16 Jeongja1-gil, Seonggeo-eup, Seobuk-gu,

Cheonan-si, Chungcheongnam-do, 331-833, Republic of Korea

Phone : (+82) 41-529-8422 Fax : (+82) 41-551-0767

Contact Person: Hak-Sung Kim

1. Date Prepared
  September 24, 2014
1. Device Name
  Common name : GlucoVitaal H1A Blood Glucose Monitoring System

Classification : Class II

(Regulation: 21 CFR § 862.1345)

Product Code :

NBW - Blood glucose test system, over the count

LFR - Glucose, Glucose dehydrogenase, glucose test system

JJX, Single (specified) analyte controls

4. Predicate Device

The difference between Predicate device (K131727) and Candidate device is name of test system, code setting and adding languages (Spanish and Portuguese) on the labeling.

The name of K131727 test system is CERA-CHEK 1070 Blood Glucose Monitoring System, while candidate device is GlucoVitaal H1A Blood Glucose Monitoring System.

Regarding the code setting, predicate device can select the coding the built-in code in meter. On the contrary, candidate device is no need to set coding because only one setting code was built-in the meter. Both of them are identical including electrode, contact port size and reactants in test strip. Therefore modification of code setting is no effect on the performance test.

Section 009

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Image /page/4/Picture/0 description: The image shows the logo for CERAGEM MEDISYS. The word "CERAGEM" is in red, and the word "MEDISYS" is in gray. To the right of the words is an orange geometric shape.

For further information, see table below for references:

	Predicate Device (K131727)	Candidate Device
Name of System device	CERA-CHEK 1070 Blood GlucoseMonitoring System	GlucoVitaal Blood GlucoseMonitoring System
Code Setting	Code key required	No code
Language	Only English	English, Spanish and Portuguese

GlucoVitaal H1A Blood Glucose Monitoring System is substantially equivalent to CERA-CHEK 1070 Blood Glucose Monitoring System described as below.

(1) Device Name: CERA-CHEK 1070 Blood Glucose Monitoring System
(2) Manufacturer: CERAGEM Medisys Inc.
(3) 510(K) Number: K131727

5. Device Description

6. Intended Use

The GlucoVitaal H1A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The GlucoVitaal H1A Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GlucoVitaal H1A 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 controls. The GlucoVitaal H1A 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).

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Image /page/5/Picture/1 description: The image contains the logo for CERAGEM MEDISYS. The word "CERAGEM" is in orange, and the word "MEDISYS" is in gray and located below the word "CERAGEM". To the right of the words is an orange geometric shape.

The GlucoVitaal H1A Blood Glucose Test Strips are for use with the GlucoVitaal H1A Blood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf.

Table2. Comparison Table
Comparison
Item	Predicate Device (K131727)	Candidate Device
Device Name	CERA-CHEK 1070 BloodGlucose Monitoring System	GlucoVitaal H1A BloodGlucose Monitoring System
Same
Detection Method	Amperometry	Amperometry
Enzyme	Glucose dehydrogenase(FAD-GDH)	Glucose dehydrogenase(FAD-GDH)
Test Time	5 seconds	5 seconds
Memory	1000 blood glucose test resultswith date and time	1000 blood glucose test resultswith date and time
Sample Volume	0.5 uL	0.5 uL
Humidity range	10-85%	10-85%
Temperature range	50-104°F10-40°C	50-104°F10-40°C
Power(Battery)	One 3-volt lithium battery(CR2032)	One 3-volt lithium battery(CR2032)
Test range	20-600 mg/dL	20-600 mg/dL
Level of QC	2 Levels (Control 1, Control 2)	2 Levels (Control 1, Control 2)
Dimensions	94mm(H) x 53.6(W) x14.9mm(T)	94mm(H) x 53.6(W) x14.9mm(T)
Weight	35g	35g

7. Comparison to Predicate Device

Section 009

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Hematocrit range	10-70%	10-70%
Difference
Name of Systemdevice	CERA-CHEK 1070 BloodGlucose Monitoring System	GlucoVitaal Blood GlucoseMonitoring System
Code Setting	Code key required	No code
Language	Only English	English, Spanish andPortuguese

Conclusion

As the comparison table, both of Candidate and Predicate device have same detection method, test time, memory, sample volume, Humidity range, temperature range, battery, test range, level of QC, dimensions, weight and hematocrit range. Furthermore Candidate device is also using same enzyme and mediator. To sum up with table, the GlucoVitaal H1A Blood Glucose Monitoring System (candidate device) is similar with the predicate device because most of the specifications deciding the characteristic of the device are same. In conclusion, despite of the difference such as mentioned above, the GlucoVitaal H1A Blood Glucose Monitoring System is substantially equivalent as compared to the predicate device.

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.