(266 days)
Not Listed
No
The description focuses on the electrochemical method of glucose measurement and does not mention any AI or ML components.
No.
This device is a blood glucose monitoring system, intended for monitoring blood glucose levels, not for directly treating a condition.
Yes
The device is described as an "in-vitro diagnostics use only" system, and its intended use is for "quantitative measurement of the glucose in fresh capillary whole blood" to help monitor the effectiveness of diabetes control. While it explicitly states it's "not to be used for the diagnosis of or screening of diabetes," the act of measuring and monitoring a physiological parameter to assess the effectiveness of a condition's control falls within the broader scope of diagnostic support, even if not for initial diagnosis.
No
The device is described as a "Blood Glucose Monitoring System" comprised of a "Blood Glucose Meter" and "Blood Glucose Test Strips," which are hardware components. While there is mention of optional software, the core system is hardware-based.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "It is intended for self-testing outside the body (invitro diagnostics use only)..."
- Nature of the Test: The device measures glucose in a biological sample (blood) outside of the body to provide information about a person's health status (diabetes control). This is the core definition of an in vitro diagnostic device.
- Device Description: The description details the chemical reaction and electrical current measurement used to determine glucose levels, which is a typical method for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Medisign GH81 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH81 Blood Glucose Monitoring System is comprised of the Medisign GH81 Blood Glucose Meter and Medisign GH81 Blood Glucose Test Strips.
The Medisign GH82 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH82 Blood Glucose Monitoring System is comprised of the Medisign GH82 Blood Glucose Meter and Medisign GH82 Blood Glucose Test Strips.
The Medisign GH83 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH83 Blood Glucose Monitoring System is comprised of the Medisign GH83 Blood Glucose Meter and Medisign GH83 Blood Glucose Test Strips.
The Medisign GH81 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH81 BT Blood Glucose Monitoring System is comprised of the Medisign GH81 BT Blood Glucose Meter and Medisign GH81 Blood Glucose Test Strips.
The Medisign GH82 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH82 BT Blood Glucose Monitoring System is comprised of the Medisign GH82 BT Blood Glucose Meter and Medisign GH82 Blood Glucose Test Strips.
The Medisign GH83 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH83 BT Blood Glucose Monitoring System is comprised of the Medisign GH83 BT Blood Glucose Meter and Medisign GH83 Blood Glucose Test Strips.
Product codes
NBW, LFR
Device Description
The Medisign GH81, GH82, GH83, GH81 BT, GH82 BT, and GH83 BT Blood Glucose Monitoring System quantitatively measures the glucose in the whole blood sample by using a harmless electrical current produced by a chemical reaction between the glucose in the blood and Flavin adenine dinucleotide-Glucose dehydrogenase (FAD-GDH) on the test strip. This current is proportionally converted to the amount of glucose in the blood sample to display as the blood glucose result. Glucose measurements from this system are reported as plasma equivalents.
The Medisign GH81, GH82, GH83, GH81 BT, GH82 BT, GH83 BT Blood Glucose Monitoring Systems are for over-the-counter use and systems' kit basically consist of a blood glucose meter, blood glucose test strips, a lancing device, sterile lancets, a carrying case, however some kits may not have test strips or a lancing device or sterile lancets. The Medisign GH81. GH82. GH83 Blood Glucose Monitoring System allows to transmit blood glucose test results to a PC via an external USB cable and Medisign GH81 BT, GH82 BT, GH83 BT Blood Glucose Monitoring System can transmit blood glucose test results to a PC via an external USB cable or a Bluetooth Low Energy transmitter in meter.
The Medisign GH81 Blood Glucose Test Strip is for the Medisign GH81 and GH81 BT Blood Glucose Meter. The Medisign GH82 Blood Glucose Test Strip is for the Medisign GH82 and GH82 BT Blood Glucose Meter. The Medisign GH83 Blood Glucose Test Strip is for the Medisign GH83 and GH83 BT Blood Glucose Meter.
Each of test strip box may contain 10 test strips or 25 test strips or 50 test strips with one vial or 50 test strips split into two vials. Also, test strip box may contain 25 or 50 test strips packed separately for each test strip.
The Medisign Link Diabetes Management Software is an optional software accessory and were previously cleared in K133260.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip, palm and forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
People with diabetes at home (self-testing)
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)
The clinical and non-clinical tests were conducted and demonstrated the performance of the candidate devices were satisfied with all pre-determined acceptance criteria. The candidate devices were compared with the YSI 2300 STAT Plus as a reference instrument to evaluate the system reliability and accuracy performance. No adverse events pertaining to the safety and effectiveness occurred during the tests.
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
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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2017
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. C/O PRISCILLA CHUNG LK CONSULTING GROUP USA, INC. 690 ROOSEVELT IRVINE, CA 92620
Re: K162564
Trade/Device Name: Medisign GH81 Blood Glucose Monitoring System Medisign GH82 Blood Glucose Monitoring System Medisign GH83 Blood Glucose Monitoring System Medisign GH81 BT Blood Glucose Monitoring System Medisign GH82 BT Blood Glucose Monitoring System Medisign GH83 BT Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345
Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: May 4, 2017 Received: May 5, 2017
Dear Priscilla 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
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 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162564
Device Name
Medisign GH81 Blood Glucose Monitoring System
Indications for Use (Describe)
The Medisign GH81 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH81 Blood Glucose Monitoring System is comprised of the Medisign GH81 Blood Glucose Meter and Medisign GH81 Blood Glucose Test Strips.
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)
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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162564
Device Name
Medisign GH82 Blood Glucose Monitoring System
Indications for Use (Describe)
The Medisign GH82 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH82 Blood Glucose Monitoring System is comprised of the Medisign GH82 Blood Glucose Meter and Medisign GH82 Blood Glucose Test Strips.
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)
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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162564
Device Name
Medisign GH83 Blood Glucose Monitoring System
Indications for Use (Describe)
The Medisign GH83 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH83 Blood Glucose Monitoring System is comprised of the Medisign GH83 Blood Glucose Meter and Medisign GH83 Blood Glucose Test Strips.
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)
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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
5
Indications for Use
510(k) Number (if known) K162564
Device Name
Medisign GH81 BT Blood Glucose Monitoring System
Indications for Use (Describe)
The Medisign GH81 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH81 BT Blood Glucose Monitoring System is comprised of the Medisign GH81 BT Blood Glucose Meter and Medisign GH81 Blood Glucose Test Strips.
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)
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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
Indications for Use
510(k) Number (if known) K162564
Device Name
Medisign GH82 BT Blood Glucose Monitoring System
Indications for Use (Describe)
The Medisign GH82 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH82 BT Blood Glucose Monitoring System is comprised of the Medisign GH82 BT Blood Glucose Meter and Medisign GH82 Blood Glucose Test Strips.
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)
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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
7
Indications for Use
510(k) Number (if known) K162564
Device Name
Medisign GH83 BT Blood Glucose Monitoring System
Indications for Use (Describe)
The Medisign GH83 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (invitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steadystate times (when glucose is not changing rapidly).
The Medisign GH83 BT Blood Glucose Monitoring System is comprised of the Medisign GH83 BT Blood Glucose Meter and Medisign GH83 Blood Glucose Test Strips.
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)
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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
8
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92
1.510(k) Number
2. Date Prepared
June 06, 2017
3. Applicant
Tianjin Empecs Medical Device Co., Ltd. No.35 and 37, Yingcheng street, Hangu, Binhai New Area, Tianjin, 300480 China Contact: Eric.Chae, Senior Regulatory Affairs Manager Phone: +86-22-2569-5007 Fax: +86-22-2569-4461 e-mail: eric@empecs.com
4. Correspondent
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92606 Tel. 714-202-5789 Email: juhee.c@lkconsultinggroup.com
5. Measurement
Glucose in fresh capillary whole blood
6. Type of Test
Quantitative, Amperometric detection, Flavin adenine dinucleotide-Glucose dehydrogenase (FAD-GDH)
7. Device Name
Medisign® GH81 Blood Glucose Monitoring System Medisign® GH82 Blood Glucose Monitoring System Medisign® GH83 Blood Glucose Monitoring System
Medisign® GH81 BT Blood Glucose Monitoring System Medisign® GH82 BT Blood Glucose Monitoring System Medisign® GH83 BT Blood Glucose Monitoring System
9
8. Common Classification Name
Blood Glucose Test System
9. Classification
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW - System, Test, Blood Glucose, | |||
| Over The Counter | Class II | 21 CFR § 862.1345 | 75-Chemistry |
| LFR - Glucose dehydrogenase, glucose | |||
| test system | Class II | 21 CFR § 862.1345 | 75-Chemistry |
10. Predicate Device Information
Device Name: OneTouch Verio Flex Blood Glucose Monitoring System 510(k) Number: K150214
11. Indications for Use
Medisign®GH81 Blood Glucose Monitoring System
The Medisign GH81 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH81 Blood Glucose Monitoring System is comprised of the Medisign GH81 Blood Glucose Meter and Medisign GH81 Blood Glucose Test Strips.
Medisign®GH82 Blood Glucose Monitoring System
The Medisign GH82 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and It is intended for self-testing outside the body (in-vitro diagnostics use only) by people forearm. with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH82 Blood Glucose Monitoring System is comprised of the Medisign GH82 Blood Glucose Meter and Medisign GH82 Blood Glucose Test Strips.
Medisign®GH83 Blood Glucose Monitoring System
The Medisign GH83 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis
10
of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH83 Blood Glucose Monitoring System is comprised of the Medisign GH83 Blood Glucose Meter and Medisign GH83 Blood Glucose Test Strips.
Medisign® GH81 BT Blood Glucose Monitoring System
The Medisign GH81 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH81 BT Blood Glucose Monitoring System is comprised of the Medisign GH81 BT Blood Glucose Meter and Medisign GH81 Blood Glucose Test Strips.
Medisign® GH82 BT Blood Glucose Monitoring System
The Medisign GH82 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH82 BT Blood Glucose Monitoring System is comprised of the Medisign GH82 BT Blood Glucose Meter and Medisign GH82 Blood Glucose Test Strips.
Medisign® GH83 BT Blood Glucose Monitoring System
The Medisign GH83 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH83 BT Blood Glucose Monitoring System is comprised of the Medisign GH83 BT Blood Glucose Meter and Medisign GH83 Blood Glucose Test Strips.
12. Device Description
The Medisign GH81, GH82, GH83, GH81 BT, GH82 BT, and GH83 BT Blood Glucose Monitoring System quantitatively measures the glucose in the whole blood sample by using a harmless electrical current produced by a chemical reaction between the glucose in the blood and Flavin adenine dinucleotide-Glucose dehydrogenase (FAD-GDH) on the test strip. This current is
11
proportionally converted to the amount of glucose in the blood sample to display as the blood glucose result. Glucose measurements from this system are reported as plasma equivalents.
The Medisign GH81, GH82, GH83, GH81 BT, GH82 BT, GH83 BT Blood Glucose Monitoring Systems are for over-the-counter use and systems' kit basically consist of a blood glucose meter, blood glucose test strips, a lancing device, sterile lancets, a carrying case, however some kits may not have test strips or a lancing device or sterile lancets. The Medisign GH81. GH82. GH83 Blood Glucose Monitoring System allows to transmit blood glucose test results to a PC via an external USB cable and Medisign GH81 BT, GH82 BT, GH83 BT Blood Glucose Monitoring System can transmit blood glucose test results to a PC via an external USB cable or a Bluetooth Low Energy transmitter in meter.
The Medisign GH81 Blood Glucose Test Strip is for the Medisign GH81 and GH81 BT Blood Glucose Meter. The Medisign GH82 Blood Glucose Test Strip is for the Medisign GH82 and GH82 BT Blood Glucose Meter. The Medisign GH83 Blood Glucose Test Strip is for the Medisign GH83 and GH83 BT Blood Glucose Meter.
Each of test strip box may contain 10 test strips or 25 test strips or 50 test strips with one vial or 50 test strips split into two vials. Also, test strip box may contain 25 or 50 test strips packed separately for each test strip.
The Medisign Link Diabetes Management Software is an optional software accessory and were previously cleared in K133260.
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| 13. Comparison with the Predicate Device
| Similarities | ||
|---|---|---|
| Features | Predicate Device (K150214) | |
| OneTouch Verio Flex Blood | ||
| Glucose Monitoring System | Subject Device (K162564) | |
| Medisign GH81, GH82, GH83 | ||
| Intended Use | Intended to quantitatively | |
| measure glucose (sugar) in fresh | ||
| capillary whole blood samples | ||
| drawn from fingertip, palm or | ||
| forearm and in venous whole | ||
| blood as an aid in monitoring the | ||
| effectiveness of glucose control. | Refer to the aforementioned | |
| Intended Use | ||
| Enzyme | FAD-GDH | Same |
| Test Principle | Amperometry | Same |
| Calibration | Plasma equivalent | Same |
| Test Sample | Capillary whole blood | Same |
| Operating Temperature | $50 ~ 104°F$ | Same |
| Operating Humidity | $10 ~ 90%RH$ | Same |
| Hematocrit Range | $20 ~ 60%$ | Same |
| Measuring Range | $20 ~ 600 mg/dL$ | Same |
| Memory Capacity | 500 test result | Same |
| Differences | ||
| Measuring Time | 5 seconds | 6 seconds |
| Battery | One 3.0V Lithium | |
| batteries(CR2032) | Two 3.0V Lithium | |
| batteries(CR2032) | ||
| Coding of Test Strip | Non-Coding | Auto coding |
| Sample Volume | $0.4 \u03bcl$ | $0.5 \u03bcl$ |
| Averaging Results | 7,14,30 and 90 days | 7,14 and 30 days |
| Alternative Site | Not Available | Palm and forearm |
| Pre/Post-meal flagging | Not available | Available |
| Test Strip Ejector | Not available | Available |
| Range Indicator | Available | Not available |
| Data Download | USB or Bluetooth Low Energy | USB |
13. Comparison with the Predicate Device
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| Similarities | ||
|---|---|---|
| Features | Predicate Device (K150214) | |
| OneTouch Verio Flex Blood | ||
| Glucose Monitoring System | Subject Device (K162564) | |
| Medisign GH81 BT, GH82 BT, | ||
| GH83 BT | ||
| Intended Use | Intended to quantitatively | |
| measure glucose (sugar) in fresh | ||
| capillary whole blood samples | ||
| drawn from fingertip, palm or | ||
| forearm and in venous whole | ||
| blood as an aid in monitoring the | ||
| effectiveness of glucose control. | Refer to the aforementioned | |
| Intended Use | ||
| Enzyme | FAD-GDH | Same |
| Test Principle | Amperometry | Same |
| Calibration | Plasma equivalent | Same |
| Test Sample | Capillary whole blood | Same |
| Operating Temperature | 50 ~ 104°F | Same |
| Operating Humidity | 10 ~ 90%RH | Same |
| Hematocrit Range | 20 ~ 60% | Same |
| Measuring Range | 20 ~ 600 mg/dL | Same |
| Memory Capacity | 500 test result | Same |
| Data Download | USB or Bluetooth Low Energy | Same |
| Differences | ||
| Measuring Time | 5 seconds | 6 seconds |
| Battery | One 3.0V Lithium | |
| batteries(CR2032) | Two 3.0V Lithium | |
| batteries(CR2032) | ||
| Coding of Test Strip | Non-Coding | Auto coding |
| Sample Volume | 0.4 $\mu$ l | 0.5 $\mu$ l |
| Averaging Results | 7,14,30 and 90 days | 7,14 and 30 days |
| Alternative Site | Not Available | Palm and forearm |
| Pre/Post-meal flagging | Not available | Available |
| Test Strip Ejector | Not available | Available |
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| Range Indicator | Available | Not available |
|---|---|---|
| ----------------- | ----------- | --------------- |
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14. Performance Test Summary
The clinical and non-clinical tests were conducted and demonstrated the performance of the candidate devices were satisfied with all pre-determined acceptance criteria. The candidate devices were compared with the YSI 2300 STAT Plus as a reference instrument to evaluate the system reliability and accuracy performance. No adverse events pertaining to the safety and effectiveness occurred during the tests.
15. Performance Test Summary
Design verification and validation tests for the candidate devices having the same intended use, fundamental scientific technology and performance characteristics as the predicate device have demonstrated and confirmed that the performance, safety and effectiveness are satisfied with those of the predicate device. Therefore, the candidate devices can be considered substantially equivalent to the predicate device cleared under K150214.