(162 days)
No
The description focuses on standard electrochemical glucose measurement technology and does not mention any AI or ML components.
No
The device is a diagnostic tool used for monitoring glucose levels, not for treating a condition, which is the purpose of a therapeutic device.
Yes
The device is intended for the quantitative measurement of glucose in blood and aids in monitoring the effectiveness of diabetes control, which are diagnostic purposes for managing a disease.
No
The device description explicitly lists hardware components such as a Test Meter, Test Strips, Lancing Device, lancets, 3V battery, and Carrying Case, indicating it is a hardware-based system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..."
- Function: The device measures glucose in a biological sample (blood) outside the body to provide information about a person's health status (diabetes control). This is the core function of an IVD.
N/A
Intended Use / Indications for Use
The LabonaCheck® Gluppy 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. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The LabonaCheck® Gluppy 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 LabonaCheck® Gluppy Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use.
The LabonaCheck® Gluppy Blood Glucose Test Strips are for use with the LabonaCheck® Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
Product codes
NBW, CGA
Device Description
The system consists of Test Meter, Test Strips, Lancing Device, lancets, 3 V battery and Carrying Case.
The system measures the amount of glucose (sugar) in whole blood. Blood is applied to the absorbent hole of the test strip and automatically drawn into the reaction zone where reaction between reagent and glucose occurs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
The LabonaCheck® Gluppy Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use.
Intended User / Care Setting
self testing outside the body (in vitro diagnostic use) by people with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KC140141
JUL Q 3 2014
CERAGEM Medisys Inc. www.ceragemmedisys.com
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.
CERAGEM®
C
MEDISYS
| 1. | Submitter | ||
|---|---|---|---|
| CERAGEM Medisys Inc. | |||
| 16, Jeongjal-gil, Seonggeo-eup, Scobuk-gu, | |||
| Cheonan-si, Chungcheongnam-do, 331-833, Republic of Korea | |||
| Phone : (82) 41-529-8427 | |||
| Fax : (82) 41-551-0767 | |||
| Contact Person: Dana Moon | |||
| ' 2. | Date Prepared | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| July 3, 2014 | |||
| 3 | Device Name, | ||
| Common name : LabonaCheck® Gluppy Blood Glucose Monitoring System | |||
| Classification : Class II | |||
| (Regulation: 21 CFR § 862.1345) | |||
| Product Code : NBW, CGA(Blood Glucose Test System, Over the Count) | |||
| 4. | Predicate Device | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| ﮯ ۔۔۔۔۔۔۔۔۔۔۔۔ | |||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |||
| The difference between Predicate device (K102751) and Candidate device is shape of the test | |||
| strip Coding and Manufacturer Address. The rest of the device is substantially equivalent to | |||
| existing device described as below. | |||
| (1) Device Name: LabonaCheck® Gluppy Blood Glucose Monitoring System | |||
| (2) Model: MG 200 | |||
| (3) Manufacturer: CERAGEM Medisys Inc. | |||
| (4) 510(K) Number: K102751 | |||
| 5. | Device Description | ||
| The system consists of Test Meter, Test Strips, Lancing Device, lancets, 3 V battery and | |||
| Carrying Case. | |||
| Section08 | Page 1 of 4 | Total 4pages |
1
The system measures the amount of glucose (sugar) in whole blood. Blood is applied to the absorbent hole of the test strip and automatically drawn into the reaction zone where reaction between reagent and glucose occurs.
| Indication for use | ||
|---|---|---|
| il (1) = (1) = (1) = (1) = (1) = (1) = (1) = (1) = (1) = (1) = (1) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = |
The LabonaCheck® Gluppy 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. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The LabonaCheck® Gluppy 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 LabonaCheck® Gluppy Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use.
The LabonaCheck® Gluppy Blood Glucose Test Strips are for use with the LabonaCheck® Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
Comparison with predicate
| Comparison | ||
|---|---|---|
| Item | Candidate Device | Predicate (K102751) |
| Device Name | LabonaCheck® Gluppy | LabonaCheck® Gluppy |
| (existing device) | ||
| Similarities | ||
| Indications for Use | Same | Quantitative measurement of glucose in |
| capillary whole blood | ||
| Testing Site | Same | Fingertip only |
| Detection Method | Same | Amperometry |
| Enzyme | Same | Glucose Oxidase |
Section08
cerngem
MEDISYS
2
CERAGEM MEDISYS
CERAGEM Medisys Inc.
| Mediator | Same | Potassium ferricyanide |
|---|---|---|
| Test range | Same | 20~600 mg/dL |
| Temperature range | Same | 50~104°F |
| 10~40°C | ||
| Sample Volume | Same | 1.0 uL |
| Operating Humidity | ||
| range | Same | 10- 80% |
| Electrode | Same | Noble metal electrode |
| Warranty | ||
| (Test Meter) | Same | 3 years |
| Power(Battery) | Same | CR2032 |
| Open use time | ||
| (Test Strips) | Same | 4 months |
| Reaction Time | Same | 5 second |
| Hematocrit range | Same | 20~60% |
| Interference | Same | Uric acid > 8.0mg/dL |
| Triglycerides > 400 mg/dL | ||
| Sodium fluoride > 500mg/dL | ||
| Memory | Same | 500 results with date and time |
| Performance | ||
| Characteristics | Same | Refer to N. Performance Characteristics |
| on 6 page | ||
| Differences | ||
| Coding | No code | Code key required |
| Shape of the test | ||
| strip | Image: test strip 1 | Image: test strip 2 |
Total 4pages
3
Image /page/3/Picture/0 description: The image contains the logo for CERAGEM MEDISYS. The text "CERAGEM" is displayed in a bold, sans-serif font on the top line. Below it, the word "MEDISYS" is printed in a smaller, sans-serif font. To the right of the text is a geometric design that appears to be a stylized representation of a medical device or technology.
CERAGEM Medisys Inc. www.ceragemmedisys.com
16, Jeongja 1-gil, Seonggeo-eup, 103-703, Sk Ventium, 522 Manufacturer Seobuk-gu, Cheonan-si, Dangjeong-dong, Gunpo-si, 435-77, Address Chungcheongnam-do, 331-833, Korea Korea
Conclusion
As the comparison table, Both of Candidate and predicate device have same test site, detection method, test range, temperature range, sample volume, operating humidity range, electrode, warranty, power, open use time, reaction time, hematocrit range, interference, memory, and performance characteristics. Furthermore Candidate Device is also using enzyme and mediator. To sum up with the similarities, candidate device is similar with the predicate device because most of the specifications deciding the characteristic of the device are same. Only the shape of the test strip and manufacturer address has been changed. In conclusion, despite of the difference such as mentioned above, the LabonaCheck® Gluppy Blood Glucose Monitoring System is substantially equivalent as compared to the predicate device.
Section08
Total 4pages
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings, rendered in a thick, black line.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2014
CERAGEM MEDISYS INC. DANA MOON 16 JEONGLAL-GIL, SEONGGEO-EUP, SEOBUK-GU CHEONAN, CHUNGCHEONGNAM-DO 331-833 KOREA
Re: K140141
Trade/Device Name: LabonaCheck® Gluppy Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: June 05, 2014 Received: June 16, 2014
Dear Dana Moon:
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 (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2-Mr. Moon
If you desire specific advice for your device on our labeling regulations (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" (21 CFR 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.goy/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
Enclosure
6
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140141
Device Name
LabonaCheck® Gluppy Blood Glucose Monitoring System
Indications for Use (Describe)
The LabonaCheck® Gluppy 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 fingertips. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The LabonaCheck® Gluppy 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 LabonaCheck® Gluppy Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The LabonaCheck® Gluppy Blood Glucose Test Strips are for use with the LabonaCheck® Gluppy Blood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
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)
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) (Signalure)
and the been and the
Stayce Beck -S
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