MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

K111456 · Tianjin Empecs Medical Device Co., Ltd. · NBW · Feb 28, 2012 · Clinical Chemistry

Device Facts

• Record ID: K111456
• Device Name: MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Tianjin Empecs Medical Device Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The systems are intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for self-testing by persons at home, is for single-patient use only, and should not be shared. It is intended for use outside the body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates. The alternative site testing (palm and forearm) in this system can only be used during steady-state blood glucose conditions. The Medisign MM1000, MM1100, and MM1200 test strips are to be used with the Medisign MM1000, MM1100, and MM1200 Blood Glucose Meters, respectively, to monitor glucose concentration of capillary whole blood. Medisign MM1000, MM1100, and MM1200 test strips and associated meters are for use in fingertip, forearm, and palm testing. The strips are intended for self-testing by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use. For over the counter use only. The systems are intended for the quantitative measurement of the concentration of glucose in 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 professional healthcare settings. It is intended for use outside of the body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates. The alternative site testing (palm and forearm) in this system can only be used during steady-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system. The Medisign MM1000 Multi, MM1100 Multi, and MM1200 Multi Blood Glucose Test strips are to be used with Medisign MM1000 Multi, MM1100 Multi, and MM1200 Multi Blood Glucose Meters, to monitor glucose concentration of capillary whole blood. Medisign MM1000 Multi, MM1100 Multi, and MM1200 Multi Blood Glucose Test strips and associated meters are for use in fingertip, forearm, and palm testing. The systems are intended for use for multiple-patient use by health care professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use. For prescription use only. Medisign Glucose Control Solutions are for use with Medisign Brand Blood Glucose Meters and Medisign Test Strips to check that the meter and test strips are working together properly. Medisign Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Medisign Glucose Control Solutions are for in vitro diagnostic use.

Device Story

System measures capillary whole blood glucose via amperometric test strips; glucose oxidase (A. Niger) reagent reacts with sample; meter processes signal to display concentration. Used by lay users at home or healthcare professionals in clinical settings. Input: 0.5 µL blood sample. Output: digital glucose reading on LCD. Includes meter, test strips, control solutions, and optional diabetes management software via USB cable. Multi-series models intended for multi-patient use with auto-disabling lancing devices to prevent cross-contamination. Aids diabetes management by providing real-time glucose data.

Clinical Evidence

Clinical performance evaluated via user performance study with 156 lay users (fingertip) and 104 subjects (palm/forearm). Compared against YSI-2300 reference method. Results showed high correlation (R² 0.975-0.981). Accuracy met ISO 15197 criteria: >95% of results within ±15 mg/dL (for <75 mg/dL) or ±15-20% (for ≥75 mg/dL) of reference values. Bench testing included precision, linearity (20-600 mg/dL), interference, hematocrit (30-55%), altitude, and temperature/humidity studies.

Technological Characteristics

Amperometric glucose oxidase (A. Niger) biosensor. Meter dimensions/form factor vary by model (MM1000/1100/1200). Energy source: DC 3V CR2032 Lithium battery. Connectivity: USB cable for data transfer. Sterilization: Not applicable (IVD). Software: Medisign Link-Diabetes Management Software. Calibration: Factory-calibrated (NIST SRM #917c traceable).

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood (fingertip, palm, forearm) to aid diabetes management. For single-patient home use or multi-patient clinical use (Multi-series). Not for neonates, diabetes diagnosis, or screening. Alternative site testing restricted to steady-state 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

• OneTouch Ultra 2 Blood Glucose Monitoring System (k053529)
• OneTouch Ultra Control Solution (k022769)

Submission Summary (Full Text)

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FEB 2 8 2012

Image /page/0/Picture/1 description: The image shows the logo for EMPECS MEDICAL DEVICE. The logo consists of a stylized graphic to the left of the text. The text is in a bold, sans-serif font. The logo is in black and white.

CONFIDENTIAL

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | K111456 |
|--------------------------------|---------|
|--------------------------------|---------|

Submitted By: Tianjin Empecs Medical Device Co., Ltd. Binhe Rd. Hangu Economic Development Zone, Hangu District, Tianiin, 300480, China Registration Number: 9616530 Contact Person: CQMS Co., Ltd. (Mr. HL Jung)

> Room 1301, Gyeonggi Venture Anyang Science University Center, 572-5, Anyang 8-dong, Manan-gu, Anyang-si, Gyeonggi-do, 430-731, Republic of Korea Tel: [phone] Fax: [phone]

Date Summary, Prepared:

Feb. 10. 2012

Device Name:

Proprietary Name: Medisign MM1000 Blood Glucose Monitoring System Medisign MM1100 Blood Glucose Monitoring System Medisign MM1200 Blood Glucose Monitoring System Medisign MM1000 Multi Blood Glucose Monitoring System Medisign MM1100 Multi Blood Glucose Monitoring System Medisign MM1200 Multi Blood Glucose Monitoring System Common Name: Glucose Test System Classification Name: Class II, 21 CFR 862.1345, Glucose Test System Class I, 21 CFR 862.1660, Quality Control Material NBW, CGA and JJX

> OneTouch Ultra 2 Blood Glucose Monitoring System (K053529) OneTouch Ultra Control Solution (K022769)

#### Device Description:

Predicate Devices:

Produce code:

Medisign MM1000 Blood Glucose Monitoring System, MM1100 Blood Glucose Monitoring System, and Medisign MM1200 Blood Glucose Monitoring System are basically provided with a blood glucose meter, blood glucose test strips (10T), and a carrying bag including user manual, quick reference manual and log book. Blood glucose test strips (25T, 50T), blood glucose control solutions (Level A, Level B), check strip, diabetes management software, and data

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# ECS MEDICAL DEVICE

transporting cable are sold separately.

Medisign MM1000 Multi Blood Glucose Monitoring System, Medisign MM1100 Multi Blood Glucose Monitoring System, and Medisign MM1200 Multi Blood Glucose Monitoring System are basically provided with a blood glucose meter, blood glucose test strips (107), and a carrying bag including user manual, quick reference manual and log book. Disposable lancing device, blood glucose test strips (25T, 50T), blood glucose control solutions (Level A, Level B), check strip, 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 - 32.3µg and buffer & non-reactant - 50.5µg.

Each box of control solutions (Level A and Level B) contains one vial of aqueous control solution (4ml each): Level A contains 0.11% concentrations of glucose (approximately 120 mg/dL) and Level B contains 0.23% concentrations of glucose (approximately 320 mg/dL).

Only the difference among six blood glucose monitoring systems above is the appearance of the top cases of the meters. Six blood glucose monitoring systems use the same PCB, the same LCD, the same Software, the same test strip, and the same control solution.

#### Intended Use:

Medisign MM1000 Blood Glucose Monitoring System, MM1100 Blood Glucose Monitoring System, and Medisign MM1200 Blood Glucose Monitoring System are intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for selftesting by persons at home, is for single-patient use only, and should not be shared. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in the systems can only be used during steady-state blood glucose conditions.

The Medisign™ MM1000 test strip is to be used with Medisign™ MM1000 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1000 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

The Medisign™ MM1100 test strip is to be used with Medisign™ MM1100 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1100 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

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#### CONFIDENTIAL

# EMPECS MEDICAL DEVICE

The Medisign™ MM1200 test strip is to be used with Medisign™ MM1200 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1200 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign MM1000 Multi Blood Glucose Monitoring System, Medisign MM1100 Multi Blood Glucose Monitoring System, and Medisign MM1200 Multi Blood Glucose Monitoring System are intended for the quantitative measurement of the concentration of glucose in 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 clinical settings. It is intended for use outside of the body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in the systems can only be used during steady-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system.

The Medisign™ MM1000 Multi Blood Glucose Test strip is to be used with Medisign™ MM1000 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1000 Multi Test strips and associated meters are for use in 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 to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

The Medisign™ MM1100 Multi Blood Glucose Test strip is to be used with Medisign™ MM1100 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1100 Multi Test strips and associated meters are for use in 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 to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

The Medisign™ MM1200 Multi Blood Glucose Test strip is to be used with Medisign™ MM1200 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1200 Multi Test strips and associated meters are for use in 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 to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign™ Glucose Control Solutions are for use with Medisign™ Brand Blood Glucose Meters and Medisign™ Test Strips to check that the meter and test strips are working together properly.

Section 5: Page 3 of 4

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# EMPECS MEDICAL DEVICE

### CONFIDENTIAL

Medisign™ Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mesisign™ Glucose Control Solutions are for in vitro diagnostic use.

### Comparison to Predicate Devices:

| Items | Subject Devices | Predicate Devices |
|-----------------------------|-------------------------------------------------|-------------------------------------------------------|
| Detection method | Amperometry | Same |
| Enzyme | Glucose Oxidase<br>(Aspergillus niger) | Same |
| Mediator | Hexaammineruthenium(III)<br>Chloride | Potassium ferricyanide |
| Electrod | Carbon electrode | Same |
| Measurement Range | 20~600mg/dL | Same |
| Hct. Range | 30-55% | Same |
| Reagent Form | Test Strip | Same |
| Sample Site | Fingertip, Palm, and Forearm | Same |
| Minimum Sample Size | 0.5 ul | 1 ul |
| Measurement Time | 5 sec | Same |
| Memory Capability | 300 test results (including date<br>and time) | 500 blood glucose or control<br>solution test results |
| Coding | Auto Coding | Manual Type |
| Operating Temperature Range | 10~40°C | 43~111°F |
| Operating Humidity Range | 10-90% | Same |
| Power | DC 3V CR2032 Lithium battery | Same |
| External Output | Data transporting cable<br>(USB type) | One Touch Interface Cable<br>(USB format) |
| Software | Medisign Link - Diabetes<br>Management Software | OneTouch Diabetes<br>Management Software |

Data demonstrating:

The clinical data demonstrate the performance of the subject devices well with the laboratory glucose reference test equipment. All predetermined acceptance criteria were satisfied. The data also demonstrate that the subject devices are substantially equivalent to the predicate devices.

Conclusion:

The subject devices are substantially equivalent to the following predicate devices:

OneTouch Ultra 2 Blood Glucose Monitoring System (K053529) and OneTouch Ultra Control Solution (K022769).

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, serif font. The text is centered horizontally in the image. The background of the image is white.

Image /page/4/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Tianjin Empecs Medical Device Co., Ltd. c/o HL Jung Room 1301 Room 1501 572-5 Anyang 8-dong, Manan-gu Anyang-si, Gyeonggi-do, 430-731, Republic of Korea

FEB 2 8 2012

Re: k111456

Re: Medisign MM1100 Blood Glucose Monitoring System Medisign MM1200 Blood Glucose Monitoring System Mcdisign MM1000 Multi Blood Glucose Monitoring System Medisign MM1100 Multi Blood Glucose Monitoring System Medisign MM1200 Multi Blood Glucose Monitoring System Medisign Glucose Control Solutions

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: February 10, 2012 Received: February 16, 2012

### Dear HL Jung:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premained is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosite) to legally managed profite Americal Device Amendments, or to commerce prior to May 28, 1976, the enactinent and of the Federal Food. Drug, Drug, Drug, devices that have been reclassified in according approval of a premarket application
and Cosmetic Act (Act) that do not require approval of a proval controls provisions and Cosmetic Act (Act) that do not require approvince to the general controls provisions of the
(PMA). You may, therefore, market the device, subject to the general control (PMA). You may, therefore, inalice the Act include requirements for annual registration, Act. The general controls provisions of the Fice Herade requeent in the mainst misbranding in and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), (PMA), If your device is classified (SEE above) into chile controls. Existing your device
it may be subject to such additional controls. Existing major regulations a 895 In add it may be subject to such additional controls. Lations (CFR), Parts 800 to 895. In addition,
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to Regis can be found in Title 21, Code of Federal Regulations (21 %) = 1. = 1.
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 Please be advised that FDA s Issualice of a substantial equivalies with other requirements of

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Page 2 -

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### KIII456 510(k) Number (if known):

Device Name: Medisign™ MM1000 Blood Glucose Monitoring System

#### Indications for Use:

The system is intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for self-testing by persons at home, is for single-patient use only, and should not be shared. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in this system can only be used during stead-state blood glucose conditions.

The Medisign™ MM1000 test strip is to be used with Medisign™ MM1000 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1000 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign™ Glucose Control Solutions are for use with Medisign™ Brand Blood Glucose Meters and Medisign " Test Strips to check that the meter and test strips are working together properly. Medisign™ Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home, Mesisign™ Glucose Control Solutions are for in vitro diagnostic use.

Prescription Use (Part 21 CFR 801 Subpart D)

#### AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 411456 510(k) _

Page 1 of 6

Tianjin Empecs Medical Device Co., Ltd.

Section 4: Page 1 of 6

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5111456 510(k) Number (if known):

Device Name: Medisign™ MM1100 Blood Glucose Monitoring System

#### Indications for Use:

The system is intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for self-testing by persons at home, is for single-patient use only, and should not be shared. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in this system can only be used during stead-state blood glucose conditions.

The Medisign™ MM1100 test strip is to be used with Medisign™ MM1100 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1100 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign™ Glucose Control Solutions are for use with Medisign™ Brand Blood Glucose Meters and Medisign The Test Strips to check that the meter and test strips are working together properly. Medisign " Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home, Mesisign "" Glucose Control Solutions are for in vitro diagnostic use.

Prescription Use (Part 21 CFR 801 Subpart D)

#### AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety KII145 510(k) _______________________________________________________________________________________________________________________________________________________________________

Page 2 of 6

Tianjin Empecs Medical Device Co., Ltd.

Section 4: Page 2 of 6

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#### KIII456 510(k) Number (if known):

Device Name: Medisign™ MM1200 Blood Glucose Monitoring System

#### Indications for Use:

The system is intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for self-testing by persons at home, is for single-patient use only, and should not be shared. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in this system can only be used during stead-state blood glucose conditions.

The Medisign™ MM1200 test strip is to be used with Medisign™ MM1200 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1200 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign TM Glucose Control Solutions are for use with Medisign™ Brand Blood Glucose Meters and Medisign The Test Strips to check that the meter and test strips are working together properly. Medisign™ Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home, Mesign" Glucose Control Solutions are for in vitro diagnostic use.

Prescription Use (Part 21 CFR 801 Subpart D)

#### AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

CARS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) = | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Page 3 of 6

Tianjin Empecs Medical Device Co., Ltd.

Section 4: Page 3 of 6

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KIII456 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

### Device Name: Medisign™ MM1000 Multi Blood Glucose Monitoring System

Indications for Use:

The system is intended for the quantitative measurement of the concentration of glucose in 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 professional healthcare settings. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in this system can only be used during stead-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system.

The Medisign™ MM1000 Multi Blood Glucose Test strip is to be used with Medisign™ MM1000 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1000 Multi Test strips and associated meters are for use in 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 to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign 10 Glucose Control Solutions are for use with Medisign™ Brand Blood Glucose Meters and Medisign™ Test Strips to check that the meter and test strips are working together properly. Medisign™ Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mesisign™ Glucose Control Solutions are for in vitro diagnostic use.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety KII1456 510(k)

Tianjin Empecs Medical Device Co., Ltd.

MM1000 series

Page 4 of 6

20

Section 4: Page 4 of 6

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#### KIII456 510(k) Number (if known):

Device Name: Medisign™ MM1100 Multi Blood Glucose Monitoring System

#### Indications for Use:

The system is intended for the quantitative measurement of the concentration of glucose in 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 professional healthcare settings. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in this system can only be used during stead-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system.

The Medisign™ MM1100 Multi Blood Glucose Test strip is to be used with Medisign™ MM1100 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1100 Multi Test strips and associated meters are for use in 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 to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign 100 Glucose Control Solutions are for use with Medisign™ Brand Blood Glucose Meters and Medisign 10 Test Strips to check that the meter and test strips are working together properly. Medisign " Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mesisign™ Glucose Control Solutions are for in vitro diagnostic use.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

CARS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 6111456 510(k)

Page 5 of 6

Tianjin Empecs Medical Device Co., Ltd.

MM1000 series

Section 4: Page 5 of 6

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KIJI456 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Medisign™ MM1200 Multi Blood Glucose Monitoring System

#### Indications for Use:

The system is intended for the quantitative measurement of the concentration of glucose in 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 professional healthcare settings. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.

The alternative site testing (palm and forearm) in this system can only be used during stead-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system.

The Medisign™ MM1200 Multi Blood Glucose Test strip is to be used with Medisign™ MM1200 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1200 Multi Test strips and associated meters are for use in 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 to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.

Medisign™ Glucose Control Solutions are for use with Medisign™ Brand Blood Glucose Meters and Medisign Th Test Strips to check that the meter and test strips are working together properly. Medisign™ Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mesisign™ Glucose Control Solutions are for in vitro diagnostic use.

Prescription Use (Part 21 CFR 801 Subpart D)

### AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) _______________________________________________________________________________________________________________________________________________________________________ K 111456

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Tianjin Empecs Medical Device Co., Ltd.

MM1000 series

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