Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System
Device Facts
| Record ID | K152534 |
|---|---|
| Device Name | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System |
| Applicant | Tianjin Empecs Medical Device Co., Ltd. |
| Product Code | NBW · Clinical Chemistry |
| Decision Date | Mar 21, 2017 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Medisign MM1000 BT, MM1100 BT, MM1200 BT Blood Glucose Monitoring Systems and the Smart Diabetes Bluetooth Blood Glucose Monitoring System are intended for single-patient use only and the Medisign MM 1000 BT MULTI, MM 1100 BT MULTI and MM 1200 BT MULTI Blood Glucose Monitoring Systems and the Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System are intended for multiple-patient use in a professional healthcare setting.
Device Story
System measures glucose in fresh capillary whole blood via electrochemical reaction; glucose oxidase on test strip reacts with blood glucose to produce electrical current; current proportional to glucose concentration. Devices include meter, test strips, control solutions, and lancing accessories. Models include single-patient home-use versions and multi-patient professional-use versions. Bluetooth wireless technology transfers results to mobile app; USB cable (RS232) also available for data transport. Healthcare providers or patients use output to monitor glucose levels and manage diabetes. System provides quantitative results; aids in clinical decision-making for diabetes management. Benefits include convenient, rapid glucose monitoring at home or in clinical settings.
Clinical Evidence
Bench testing only. Verification tests conducted to confirm that modifications (Bluetooth integration, cosmetic changes) did not impact performance, safety, or effectiveness compared to the predicate device.
Technological Characteristics
Electrochemical glucose test system using glucose oxidase (Aspergillus Niger). Carbon electrode material. Measuring range 20-600 mg/dL; 5-second measurement time. Sample volume 0.5 µL. Connectivity via Bluetooth 4.0 and USB (RS232). Powered by two 3.0V CR2032 lithium batteries. Auto-coding. Complies with FCC Part 15 for RF capability.
Indications for Use
Indicated for quantitative glucose measurement in fresh capillary whole blood from fingertip, palm, or forearm as an aid in diabetes management. For single-patient home use or multi-patient professional healthcare use. Not for diabetes diagnosis, screening, or neonatal use. Alternative site testing restricted to steady-state glucose conditions.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Medisign MM1000 Blood Glucose Monitoring System (k111456)
- Medisign MM1100 Blood Glucose Monitoring System (k111456)
- Medisign MM1200 Blood Glucose Monitoring System (k111456)
- Medisign MM1000 Multi Blood Glucose Monitoring System (k111456)
- Medisign MM1100 Multi Blood Glucose Monitoring System (k111456)
- Medisign MM1200 Multi Blood Glucose Monitoring System (k111456)
Related Devices
- K142785 — PRODIGY iConnect Blood Glucose Monitoring System · Ok Biotech Co., Ltd. · Dec 17, 2015
- K133509 — EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO · Biotest Medical Corp. · Feb 21, 2014
- K191657 — Bioland Blood Glucose Monitoring System · Bioland Technology, Ltd. · Mar 20, 2020
- K103116 — AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM · Bestgen Biotech Corp. · Mar 13, 2012
- K080283 — IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM · Taidoc Technology Corporation · Jun 27, 2008
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 21, 2017
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. C/O JIGAR SHAH MDI CONSULTANTS, INC. 55 NORTHERN BLVD., SUITE 200 GREAT NECK NY 11021
Re: K152534
Trade/Device Name: Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT Multi Blood Glucose Monitoring System. Medisign MM 1100 BT Multi Blood Glucose Monitoring System, Medisign MM 1200 BT Multi Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: March 17, 2017 Received: March 20, 2017
Dear Jigar Shah:
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
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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 (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/Resourcesfor You/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 Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K152534
#### Device Name
Medisign MM1000 BT Blood Glucose Monitoring System
#### Indications for Use (Describe)
Medisign MM1000 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 by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Medisign MM1000 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1000 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Type of Use (Select one or both, as applicable)
| | Research Use (Part 21 CFR 201.3 Subject to Discretion) |
|--|------------------------------------------------------------------|
| | <i>In-Vitro</i> Control Use (21 CFR 201.3 Subject to Discretion) |
| | 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 Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
{3}------------------------------------------------
510(k) Number (if known) K152534
#### Device Name
Medisign MM1100 BT Blood Glucose Monitoring System
#### Indications for Use (Describe)
Medisign MM1100 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 by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Medisign MM1100 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1100 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <span style="margin-right: 5px;">☐</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="margin-right: 5px;">❌</span> 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
{4}------------------------------------------------
510(k) Number (if known) K152534
Device Name MM1200 BT Blood Glucose Monitoring System
#### Indications for Use (Describe)
Medisign MM1200 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 by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Medisign MM1200 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1200 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
### 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
{5}------------------------------------------------
510(k) Number (if known) K152534
#### Device Name
Smart Diabetes Bluetooth Blood Glucose Monitoring System
#### Indications for Use (Describe)
Smart Diabetes Bluetooth Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Smart Diabetes Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Smart Diabetes Glucose Control Solutions are intended for use with the Smart Diabetes Bluetooth meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.
| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|--------------------------------------------------------------|-----------------------------------------------|
| <span></span> ☐ 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
{6}------------------------------------------------
510(k) Number (if known) K152534
#### Device Name
Medisign MM1000 BT MULTI Blood Glucose Monitoring System
#### Indications for Use (Describe)
Medisign MM1000 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (in-vitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Medisian MM1000 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1000 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
### 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
{7}------------------------------------------------
510(k) Number (if known) K152534
#### Device Name
Medisign MM1100 BT MULTI Blood Glucose Monitoring System
#### Indications for Use (Describe)
Medisign MM1100 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (in-vitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Medisian MM1100 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1100 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
| 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
{8}------------------------------------------------
510(k) Number (if known) K152534
#### Device Name
Medisign MM1200 BT MULTI Blood Glucose Monitoring System
#### Indications for Use (Describe)
Medisign MM1200 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (in-vitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Medisian MM1200 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1200 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
| 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
{9}------------------------------------------------
510(k) Number (if known) K152534
#### Device Name
Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System
#### Indications for Use (Describe)
Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (in-vitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Smart Diabetes Pro Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Pro Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Smart Diabetes Glucose Control Solutions are for use with both the Smart Diabetes Bluetooth Pro meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="display:inline-block;"> <span style="display:inline-block;">☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> | <span style="display:inline-block;"> <span style="display:inline-block;">☑</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> |
### 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
{10}------------------------------------------------
# 510(K) SUMMARY
The assigned 510(k) number is: K152534
Date Summary Prepared: March 9, 2016
# 1. Submitter's Identification:
Tianjin Empecs Medical Device Co., Ltd. No.35 and 37, Yingcheng Street, Hangu, Binhai New Area, 300480 Tianjin China
Tel: +86(0)22-2569-6839
### Contact Person:
Jigar Shah MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
### 2. Name of the Device:
### Proprietary Names:
- Medisign® MM1000 BT Blood Glucose Monitoring System
- Medisign® MM1100 BT Blood Glucose Monitoring System
- Medisign® MM1200 BT Blood Glucose Monitoring System
- Smart Diabetes Bluetooth Blood Glucose Monitoring System
- . Medisign® MM1000 BT MULTI Blood Glucose Monitoring System
- . Medisign® MM1100 BT MULTI Blood Glucose Monitoring System
- Medisign® MM1200 BT MULTI Blood Glucose Monitoring System ●
- Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System .
#### Common or Usual Name: Glucose Test System
| Classification Name: | Class II, 21 CFR 862.1345, Glucose Test System<br>Class I, 21 CFR 862.1660, Quality Control Material |
|----------------------|------------------------------------------------------------------------------------------------------|
| Product code: | NBW, CGA and JJX |
### 3. Predicate Device Information:
K111456 Medisign® Blood Glucose Monitoring System
# 4. Device Description:
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Tianjin Empecs Medical Device Co., Ltd.
Medisign® Blood Glucose Monitoring System measures the glucose in the fresh capillary whole blood sample by using a small electrical current produced by chemical reaction between glucose in the blood and glucose oxidase 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 are reported as plasma equivalents. Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood equivalent test strips.
Medisign® MM 1000 BT Blood Glucose Monitoring System, Medisign® MM 1100 BT Blood Glucose Monitoring System, Medisign® MM1200 BT and Smart Diabetes Bluetooth Blood Glucose Monitoring System are basically provided with a blood glucose meter and a carrying bag including user manual, quick reference manual and log book. Blood glucose test strips (10T, 25T, 50T), blood glucose control solutions (Level 1, Level 3), lancing device, lancets, batteries (CR2032), diabetes management software, and data transporting cable are sold separately.
Medisign® MM1000 BT MULTI Blood Glucose Monitoring System, Medisign® MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign® MM1200 BT MULTI and Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System are basically provided with a blood glucose meter and a carrying bag including user manual, quick reference manual. Disposable lancing device, blood glucose test strips (10T, 25T, 50T), blood glucose control solutions (Level 1, Level 3), batteries (CR2032) diabetes management software, and data transporting cable are sold separately.
Each box of test strips contains one vial of 10 test strips, one vial of 25 test strips, one vial of 50 test strips, or two vials of 25 test strips. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) -2.5 units, redox mediator - 32.3 µg and buffer & non-reactant - 50.5µg
Each box of control solutions (Level 1, Level 2 and Level 3) contains one vial of aqueous control solution (4ml each): Level 1 contains 0.03% concentrations of glucose (approximately 40 mg/dL), Level 2 contains 0.11% concentrations of glucose (approximately 85 mg/dL) and Level 3 contains 0.23% concentrations of glucose (approximately 260 mg/dL).
The system contains Bluetooth wireless technology. This device complies with U.S. federal guidelines, Part 15 of the FCC Rules for devices with RF capability. Operation is subject to the following two conditions:
- This device may not cause harmful interference.
- · This device must accept any interference received, including interference that may cause undesirable operation.
The Bluetooth wireless technology is used to transfer meter test results to a mobile APP.
# 5. Intended Use:
### <For single patient use>
Medisign MM1000 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 by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Medisign MM1000 Blood Glucose Test Strips are to be used for monitoring glucose concentration
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of fresh capillary whole blood with Medisign MM1000 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Medisign MM1100 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 by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Medisign MM1100 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1100 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Medisign MM1200 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 by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Medisign MM1200 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1200 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Smart Diabetes Bluetooth Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (invitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Smart Diabetes Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
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Smart Diabetes Glucose Control Solutions are intended for use with Smart Diabetes Bluetooth meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.
### <For multiple patient use>
Medisign MM1000 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Medisign MM1000 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1000 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only autodisabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Medisign MM1100 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Medisign MM1100 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1100 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only autodisabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Medisign MM1200 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Medisign MM1200 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1200 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only auto
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disabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Smart Diabetes Pro Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Pro Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Smart Diabetes Glucose Control Solutions are for use with the Smart Diabetes Bluetooth Pro meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.
| Similarities | | | |
|-----------------------|----------------------------------------|------------------|----------------|
| Features | Predicate Device<br>(K111456) | Candidate Device | SE<br>Decision |
| Intended Use | Refer to the Intended Use<br>Section | Same | SE |
| Enzyme | Glucose Oxidase (Aspergillus<br>Niger) | Same | SE |
| Test Principle | Electrochemical reaction | Same | SE |
| Test Sample | Fresh capillary whole blood | Same | SE |
| Electrode Material | Carbon | Same | SE |
| Coding of Test Strip | Auto coding | Same | SE |
| Calibration | Plasma equivalent | Same | SE |
| Operating Temperature | 50 - 104°F | Same | SE |
| Operating Humidity | 10 - 90%RH | Same | SE |
# 6. Comparison to Predicate Devices:
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| Hematocrit Range | 30 - 55% | Same | SE |
|------------------------------------|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|
| Alternate Site Testing<br>Site | Palm, Forearm | Same | SE |
| Measuring Time | 5 seconds | Same | SE |
| Sample Volume | Minimum 0.5 micro liter | Same | SE |
| Measuring Range | 20 - 600 mg/dL | Same | SE |
| Pre/Post-meal flagging | Available | Same | SE |
| Battery Life | Approximately more than 1,000<br>tests | Same | SE |
| Battery | Two(2) 3.0V Lithium batteries<br>(CR2032) | Same | SE |
| Test Strip Ejector | Available | Same | SE |
| Memory Capacity | 300 results with date, time and<br>flags | Same | SE |
| Averaging Results | 14 days | Same | SE |
| Differences | | | |
| Data Transporting<br>Features | USB Cable (RS232) | ■ USB Cable (RS232)<br>■ Wireless (Bluetooth 4.0) | - |
| Meter Exterior Color | - | Meter exterior color has been<br>changed (refer to the<br>Description of the<br>Modification attached for the<br>meter exterior colors). | - |
| Meter Display Icon | - | ■ Modification of Mute icon<br>■ Adding Bluetooth icon | - |
| New control solution<br>trade name | - | ■ Smart Diabetes Glucose<br>Control Solution for use with<br>Smart Diabetes Bluetooth<br>Blood Glucose Monitoring<br>System and Smart Diabetes<br>Bluetooth Pro Blood Glucose<br>Monitoring System | - |
# 7. Discussion of Performance Tests:
The modified device has the same intended use, fundamental scientific technology and performance characteristics as the predicate device. Therefore, the performance, safety and
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effectiveness have not been changed from the predicate device. However, to confirm these changes have not brought any unexpected functional failure or adverse effect, verification tests were conducted as mentioned in Design Control Activity Summaries.
# 8. Conclusions:
Based on the outcome of the verification testing conducted, the modified subject device is substantially equivalent to the predicate device.
