(79 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
Explanation: The device is a Blood Glucose Monitoring System intended for measurement of glucose, not for treatment or therapy. It acts as an aid to monitor the effectiveness of diabetes controls.
No
The provided text explicitly states that "The GlucoVitaal H1 A Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use." It is intended for monitoring purposes by people already diagnosed with diabetes, not for initial diagnosis.
No
The device description explicitly lists hardware components such as a Blood Glucose Test Meter, Test Strips, Glucose Control Solution, and a Lancing device. This indicates it is a system with physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The GlucoVitaal H A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)..."
- Nature of the Test: The system measures glucose in blood samples outside the body, which is the definition of an in vitro diagnostic test.
- Components: The system includes test strips and control solutions, which are typical components of IVD systems used for chemical analysis of biological samples.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, forearm, upper arm, palm, thigh, or calf.
Indicated Patient Age Range
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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
2
Indications for Use
510(k) Number (if known) K141829
Device Name
GlucoVitaal H1A Blood Glucose Monitoring System
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
-
- Date Prepared
September 24, 2014
- Date Prepared
-
- Device Name
Common name : GlucoVitaal H1A Blood Glucose Monitoring System
- Device Name
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
4
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 Glucose | |
| Monitoring System | GlucoVitaal Blood Glucose | |
| Monitoring 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
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.
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).
5
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.
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.
| Table2. Comparison Table | ||
|---|---|---|
| Comparison | ||
| Item | Predicate Device (K131727) | Candidate Device |
| Device Name | CERA-CHEK 1070 Blood | |
| Glucose Monitoring System | GlucoVitaal H1A Blood | |
| Glucose 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 results | |
| with date and time | 1000 blood glucose test results | |
| with date and time | ||
| Sample Volume | 0.5 uL | 0.5 uL |
| Humidity range | 10-85% | 10-85% |
| Temperature range | 50-104°F | |
| 10-40°C | 50-104°F | |
| 10-40°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) x | |
| 14.9mm(T) | 94mm(H) x 53.6(W) x | |
| 14.9mm(T) | ||
| Weight | 35g | 35g |
7. Comparison to Predicate Device
Section 009
6
| Hematocrit range | 10-70% | 10-70% |
|---|---|---|
| Difference | ||
| Name of System | ||
| device | CERA-CHEK 1070 Blood | |
| Glucose Monitoring System | GlucoVitaal Blood Glucose | |
| Monitoring System | ||
| Code Setting | Code key required | No code |
| Language | Only English | English, Spanish and |
| Portuguese |
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.