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.

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.

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.

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 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.

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.

Device Description

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.

AI/ML Overview

The provided text describes several Medisign and Smart Diabetes Bluetooth Blood Glucose Monitoring Systems, all under K152534. The submission claims substantial equivalence to a predicate device (K111456 Medisign® Blood Glucose Monitoring System) and includes performance testing of the modified device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The text explicitly states that the modified devices aim to demonstrate substantial equivalence to the predicate device, implying that the performance of the modified device should align with that of the predicate. It then lists "Similarities" and "Differences" between the candidate device (the various Medisign and Smart Diabetes systems) and the predicate device (K111456). While it doesn't present a formal acceptance criteria table with numerical targets, it lists the characteristics that are considered "Same" as the predicate device.

Feature / Acceptance Criteria (Implied: Same as Predicate)	Reported Device Performance (as stated in "Similarities")
Intended Use	Same
Enzyme	Same (Glucose Oxidase (Aspergillus Niger))
Test Principle	Same (Electrochemical reaction)
Test Sample	Same (Fresh capillary whole blood)
Electrode Material	Same (Carbon)
Coding of Test Strip	Same (Auto coding)
Calibration	Same (Plasma equivalent)
Operating Temperature	Same (50 - 104°F)
Operating Humidity	Same (10 - 90%RH)
Hematocrit Range	Same (30 - 55%)
Alternate Site Testing Site	Same (Palm, Forearm)
Measuring Time	Same (5 seconds)
Sample Volume	Same (Minimum 0.5 microliter)
Measuring Range	Same (20 - 600 mg/dL)
Pre/Post-meal flagging	Same (Available)
Battery Life	Same (Approximately more than 1,000 tests)
Battery	Same (Two (2) 3.0V Lithium batteries (CR2032))
Test Strip Ejector	Same (Available)
Memory Capacity	Same (300 results with date, time and flags)
Averaging Results	Same (14 days)

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

The document mentions "verification tests were conducted" (page 16) but does not provide any specific details about the sample sizes used for these tests. There is also no explicit mention of data provenance (country of origin) or whether the studies were retrospective or prospective.

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

For a blood glucose monitoring system, the "ground truth" is typically an established laboratory reference method (e.g., using a YSI glucose analyzer) rather than expert consensus on images or clinical assessments. The document does not mention the involvement of experts for establishing ground truth in the context of radiologists or similar clinical reviewers. The ground truth for glucose measurements would be provided by a highly accurate laboratory instrument.

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

Given that the device measures a quantitative value (glucose concentration) against an established reference method, an adjudication method like 2+1 or 3+1 (which are typically used for qualitative or subjective assessments in imaging or pathology) is not applicable or mentioned in the context of this device. The comparison would be a direct quantitative comparison between the device reading and the reference method reading.

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

This type of study (MRMC, measuring improvement with AI assistance) is not relevant to a blood glucose monitoring system, which is a standalone diagnostic device, not an AI-assisted diagnostic imaging tool. Therefore, no such study was done or reported here.

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

Yes, the performance testing described implicitly as "verification tests" (page 16) would be a standalone performance evaluation of the device (meter and test strip system) measuring glucose concentrations. The device itself (the algorithm within the meter) provides the result without human interpretation of raw data, beyond operating the device. While "algorithm only" implies a pure software evaluation, this would be the closest analogue for a medical device that produces a direct numerical output.

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

For a blood glucose monitoring system, the ground truth is established by a reference laboratory method for glucose measurement, typically a highly accurate and precise enzymatic method often run on a laboratory analyzer (e.g., YSI glucose analyzer). While not explicitly stated, this is the standard for validating such devices. The document mentions "Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood equivalent test strips," which further indicates a comparison to a standardized laboratory method that often reports plasma glucose.

8. The sample size for the training set

The document describes a 510(k) submission for modified devices, claiming substantial equivalence. It refers to "verification tests" for the modified device based on its similarity to a predicate device. No mention is made of a "training set" as would be used for machine learning. The device operates based on established electrochemical principles, not a learnable algorithm that requires training data in the AI sense.

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

As there is no mention of a training set in the context of an AI/machine learning model, this question is not applicable. The device's operation relies on chemical reactions and electrical current measurements, calibrated against reference glucose values derived from a laboratory method.

Summary

{0}------------------------------------------------

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

{1}------------------------------------------------

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

{2}------------------------------------------------

510(k) Number (if known) K152534

Device Name

Medisign MM1000 BT Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Research Use (Part 21 CFR 201.3 Subject to Discretion)
	In-Vitro 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)

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.

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)

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.

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).

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 ( 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.

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)
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.

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.

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.

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.

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)
☑ 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.

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 SystemClass 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:

{11}------------------------------------------------

Tianjin Empecs Medical Device Co., Ltd.

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:

The Medisign MM1000 Blood Glucose Test Strips are to be used for monitoring glucose concentration

{12}------------------------------------------------

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.

{13}------------------------------------------------

{14}------------------------------------------------

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.

Similarities
Features	Predicate Device(K111456)	Candidate Device	SEDecision
Intended Use	Refer to the Intended UseSection	Same	SE
Enzyme	Glucose Oxidase (AspergillusNiger)	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:

{15}------------------------------------------------

Hematocrit Range	30 - 55%	Same	SE
Alternate Site TestingSite	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 1,000tests	Same	SE
Battery	Two(2) 3.0V Lithium batteries(CR2032)	Same	SE
Test Strip Ejector	Available	Same	SE
Memory Capacity	300 results with date, time andflags	Same	SE
Averaging Results	14 days	Same	SE
Differences
Data TransportingFeatures	USB Cable (RS232)	■ USB Cable (RS232)■ Wireless (Bluetooth 4.0)	-
Meter Exterior Color	-	Meter exterior color has beenchanged (refer to theDescription of theModification attached for themeter exterior colors).	-
Meter Display Icon	-	■ Modification of Mute icon■ Adding Bluetooth icon	-
New control solutiontrade name	-	■ Smart Diabetes GlucoseControl Solution for use withSmart Diabetes BluetoothBlood Glucose MonitoringSystem and Smart DiabetesBluetooth Pro Blood GlucoseMonitoring 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

{16}------------------------------------------------

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.

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.