(247 days)
Not Found
No
The document describes a standard blood glucose monitoring system based on electrochemical measurement and associated software for data management. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a diagnostic tool used for measuring blood glucose levels, aiding in the monitoring of diabetes control. It does not provide therapy or treatment.
No
The document explicitly states: "The Medisign® MM3000 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use."
No
The device description explicitly includes hardware components such as a blood glucose meter, test strips, lancing device, and lancets. While it mentions "Medisign Link Diabetes Management Software," this software is described as PC-based and intended for data review and analysis, not as the primary medical device itself. The core function of glucose measurement relies on the hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Medisign® MM3000 Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)..." and "The Medisign® Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use)..."
- Definition of IVD: An in vitro diagnostic device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This device measures glucose in a blood sample.
- Purpose: The system is used to quantitatively measure glucose in blood samples to aid in monitoring the effectiveness of diabetes control. This is a diagnostic purpose performed outside the body.
N/A
Intended Use / Indications for Use
The Medisign® MM3000 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Medisign® MM3000 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Medisign® MM3000 meter contains some speaking functions but is not intended for use by the visually impaired.
The Medisign® MM3000 Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Medisign® MM3000 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Medisign® MM3000Test Strips are for use with the Medisign® MM3000 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The Medisign® Glucose Control Solutions are intended for use with the Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.
The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, and evaluation of glucose test results for effective controlling and managing blood glucose.
The Medisign® MM3000 Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) fresh capillary whole blood from fingertip, palm, or forearm. The Medisign® MM3000 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The Medisign® MM3000 Multi meter contains some speaking functions but is not intended for use by the visually impaired.
The Medisign® MM3000 Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Medisign® MM3000 Multi Blood Glucose Test Strips are for use with the Medisign® MM3000 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The Medisign® MM3000 Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.
The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, and evaluation of glucose test results for effective controlling and managing blood glucose.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX, JQP
Device Description
Medisign Blood Glucose Monitoring System measures the glucose in the whole blood sample by using a small electrical current produced by chemical reaction between glucose in the blood and glucose oxidase (GOD) 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 referenced test strips.
Medisign MM3000 Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, a lancing device, sterile lancets, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Blood glucose test strips, blood glucose control solutions (1, 2, 3 levels), diabetes management software, and data transporting cable are sold separately.
Medisign MM3000 Multi Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Disposable lancing device, blood glucose test strips, blood glucose control solutions (1,2,3 levels), 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. Also, each box may contain 25 test strips packed with single aluminum foiled pack or 50 test strips packed with single aluminum foiled pack. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) -2.5 units, redox mediator - 32.3ug and buffer & non-reactant - 50.5uq.
Each box of control solutions (1, 2, 3 levels) contains one vial of aqueous control solution (4ml each): Level 1 contains 0.03% concentrations of glucose (approximately 40 mg/dL) and 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by a single person for self-testing at home.
Multiple-patient use in professional healthcare settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modified device has the same intended use, fundamental scientific technology and performance characteristics as the predicate device. Therefore, the performance, safety and effectiveness have not been changed from the predicate device. However, to confirm these changes have not brought any unexpected functional failure or adverse effect, a system performance test including human factor study was conducted. The test procedures were all the same as those applied to the predicate device submission. As a result, all tests have been proved satisfactory according to the predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
JUN 2 7 2014
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
-
- Type of 510(k): Traditional 510(k)
-
- Prepared Date:
May 2, 2014
3. Submission Sponsor:
Tianjin Empecs Medical Device Co., Ltd.
4. Address:
No.35 and 37, Yingcheng street, Hangu, Binhai New Area, Tianjin, 300480 China
5. Contact:
Eric.Chae, Regulatory Affairs Manager Phone: +82-70-7124-0474 Fax: +82-31-776-4496
-
- Registration Number: 9616530
7. Measurement:
Whole blood glucose
8. Type of Test:
Quantitative, utilizing Glucose Oxidase technology
9. Device Name:
Medisign MM3000 Blood Glucose Monitoring System Medisign MM3000 Multi Blood Glucose Monitoring System
510k Summary
1
10. Common Classification Name:
Blood Glucose Test System
11. Classification:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW - System, Test, Blood | |||
| Glucose, Over The Counter | Class II | 21 CFR 862.1345 | 75-Chemistry |
| CGA - Glucose Oxidase, | |||
| Glucose | Class II | 21 CFR 862.1345 | 75-Chemistry |
| JJX - Quality Control | |||
| Material | Class I | 21 CFR 862.1660 | 75-Chemistry |
| JQP - Calculator/data | |||
| processing module for | |||
| clinical use. | Class I | 21 CFR 862.2100 | 75-Chemistry |
12. Predicate Device Information:
| Device Name: | Medisign MM1100 Blood Glucose Monitoring System,
Medisign MM1100 Multi Blood Glucose Monitoring System |
|----------------|-----------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K111456 |
13. Intended Use
Medisign* MM3000 Blood Glucose Monitoring System
The Medisign® MM3000 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Medisign® MM3000 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Medisign® MM3000 meter contains some speaking functions but is not intended for use by the visually impaired.
The Medisign® MM3000 Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Medisign® MM3000 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Medisign® MM3000Test Strips are for use with the Medisign® MM3000 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the
2
fingertips, forearm or palm.
The Medisign® Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.
The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective controlling and managing blood glucose.
Medisign® MM3000 Multi Blood Glucose Monitoring System
The Medisign® MM3000 Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) fresh capillary whole blood from fingertip, palm, or forearm. The Medisign® Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The Medisign® MM3000 Multi meter contains some speaking functions but is not intended for use by the visually impaired.
The Medisign® MM3000 Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Medisign® MM3000 Multi Blood Glucose Test Strips are for use with the Medisign® MM3000 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The Medisign® MM3000 Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.
The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their
3
healthcare professionals in the review, analysis and evaluation of glucose test results for effective controlling and managing blood glucose.
14. Device Description
Medisign Blood Glucose Monitoring System measures the glucose in the whole blood sample by using a small electrical current produced by chemical reaction between glucose in the blood and glucose oxidase (GOD) 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 referenced test strips.
Medisign MM3000 Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, a lancing device, sterile lancets, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Blood glucose test strips, blood glucose control solutions (1, 2, 3 levels), diabetes management software, and data transporting cable are sold separately.
Medisign MM3000 Multi Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Disposable lancing device, blood glucose test strips, blood glucose control solutions (1,2,3 levels), 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. Also, each box may contain 25 test strips packed with single aluminum foiled pack or 50 test strips packed with single aluminum foiled pack. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) -2.5 units, redox mediator - 32.3ug and buffer & non-reactant - 50.5uq.
Each box of control solutions (1, 2, 3 levels) contains one vial of aqueous control solution (4ml each): Level 1 contains 0.03% concentrations of glucose (approximately 40 mg/dL) and 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).
4
15. Device Modifications
The modified Medisign MM3000Blood Glucose Monitoring System and Medisign MM3000 Multi Blood Glucose Monitoring System have the following that are identically same as the predicate device:
- = Intended use
- □Operation principle
- · []Fundamental scientific technology
- = □Raw materials
- = [Operation environment
- = □Measuring range
The modifications from the predicate device are as follows:
- ■Meter shape
- · [] Type of a battery
- = □Change to the memory capacity
- Change to the expiration date of the test strip 트
- I Change to assigned Glucose Control Solutions level title(from A,B to 2,3)
- Addition of an Glucose Control Solution low level (level title: Level 1) .
- ■Addition of an alarm function
- □ Addition of the hypoglycemic indicator
- = [ Addition of average results for 7,28 days
- = □Addition of a lancing device to the meter set for single user
- = []Addition of a voice function feature
- Addition of a single test strip package ■
- □Exclude a check strip as the optional components (Control Solutions are enough to cover the check strip function of the control test)
16. Comparison to the Predicate Device
| Similarities | |||||
|---|---|---|---|---|---|
| Features | Predicate Device | ||||
| (K111456) | Candidate Device | SE | |||
| Decision | |||||
| Intended Use | Refer to the Intended Use | ||||
| Section | Same | SE | |||
| Enzyme | Glucose Oxidase (Aspergillus | ||||
| Niger) | Same | SE |
5
| Test Principle | Electrochemical reaction | Same | SE | |
|---|---|---|---|---|
| Test Sample | 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 | |
| Hematocrit Range | 30 - 55% | Same | SE | |
| Alternate Site Testing | ||||
| 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 | Yes | Same | SE | |
| Battery Life | Approximately | |||
| more | ||||
| than | ||||
| 1,000 tests | Same | SE | ||
| Test Strip Ejector | Available | Same | SE | |
| Differences | ||||
| Battery | Two(2) 3.0V Lithium | |||
| batteries(CR2032) | Two(2) 1.5V Alkaline | |||
| batteries(LR03, AAA) | - | |||
| Memory Capacity | 300 results with date, time | |||
| and flag | 500 results with date, time | |||
| and flag | - | |||
| Test Strip Expiration | ||||
| Date | 18 months | |||
| (3 months after first opening) | 24 months | |||
| (3 months after first opening) | - | |||
| Glucose Control | ||||
| Solution Level Title | Level A | |||
| Level B | Level 1 | |||
| Level 2 | ||||
| Level 3 | - | |||
| Alarm Function | N/A | Three(3) different interval | ||
| settings available | - | |||
| Hypoglycemic | ||||
| indicator | N/A | Available | - | |
| Averaging Results | 14 days | 7,14 and 28 days | - |
510k Summary
6
| Lancing Device for
single user | N/A | Included to the single user
system(for Over the count use
only) | - |
|-----------------------------------|--------------------|--------------------------------------------------------------------------------------------|---|
| Voice Function | N/A | Available | - |
| Test Strip Packaging | Desiccant vial | • Desiccant vial or
• Waterproof aluminum foil
pack for single test strip
packing | - |
| Check Strip | Optional Component | N/A | - |
17. Performance Evaluation of Modified Device
The modified device has the same intended use, fundamental scientific technology and performance characteristics as the predicate device. Therefore, the performance, safety and effectiveness have not been changed from the predicate device. However, to confirm these changes have not brought any unexpected functional failure or adverse effect, a system performance test including human factor study was conducted. The test procedures were all the same as those applied to the predicate device submission. As a result, all tests have been proved satisfactory according to the predetermined acceptance criteria. Refer to section #13 for the procedures and results.
18. Summary of Design Control Activities
13.1 Risk analysis
The Risk assessment was conducted and The risk analysis method used to assess the impact of the modification was a Failure Modes and Effects Analysis(FMEA). Detected risks were assessed and controlled as low as possible.
13.2 Disinfection Study
Disinfectant CaviWipes® with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of the live virus inoculated on the materials of the meter and the reusable lancing device. The result showed that the disinfectant in preventing the spread of blood born pathogens, particularly hepatitis B virus(HBV).
A robustness performance test for a reusable lancing device also demonstrated that with 200 precleanings and 200 disinfection cycles, which is equivalent to 1 times use per a week for 3 years for the lay user at home. As a result, there was no deterioration on the performance or external materials of the lancing device.
A robustness performance test for the meter demonstrated that with 1,100 pre-cleanings and 1,100 disinfection cycles, which is equivalent to 10 times use per day for 3 years in a professional
7
setting. The number of the cycle also includes those for the lay user at home. As a result, there was no deterioration on the performance or external materials of the meter.
13.3 Verification Activities for Modified Features
Verification activities were successfully executed to validate the modification and all test results fell within the acceptance criteria.(see attachment section #24)
8
Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing-like shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Scrvice
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. C/O PRISCILLA CHUNG 2651 E CHAPMAN AVE STE 100 FULLERTON CA 92831
June 27, 2014
Re: K133260
Trade/Device Name: Medisign MM3000 Blood Glucose Monitoring System, Medisign MM3000 Multi Blood Glucose Monitoring System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX, JQP Dated: May 20, 2014 Received: May 20, 2014
Dear Ms. Priscilla Chung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of 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.
9
Page 2-Ms. Chung
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
10
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133260
Device Name
Medisign MM3000 Blood Glucose Monitoring System
Indications for Use (Describe)
The Medisign® MM3000 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forcarm or palm. The Medisign® MM3000 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Medisign® MM3000 meter contains some speaking functions but is not intended for use by the visually impaired.
The Medisign® MM3000 Blood Glucose Monitoring System is intended for self-lesting outside the body (in vitro diagnosic use) by people with diabetes at home as an aid to monitor the effectivencs of diabeles control. The Medisign® MM3000 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Medisign® MM3000Test Strips are for use with the Medisign® MM3000 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The Medisian® Glucose Control Solutions are intended for use with the Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.
The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, and evaluation of glucose test results for effective controlling and managing blood glucose.
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)
..
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
11
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
12
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (it known) K133260
Device Name
Medisign MM3000 Multi Blood Glucose Monitoring System
Indications for Use (Describe)
The Medisign® MM3000 Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) fresh capillary whole blood from fingertip, palm, or forearm. The Mecisign® MM30001 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The Medisign® MM3000 Multi meter contains some speaking functions but is not intended for use by the visually impaired.
The Medisign® MM3000 Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucoss: is not changing rapidly).
The Medisign® MM3000 Multi Blood Glucose Test Strips are for use with the Medisign® MM3000 Multi Bloud Glucose Meter to quantitatively measure glucose (sugar) fresh capillary whole blood samples drawn from the lingertips, forearm or palm.
The Medisign® MM3000 Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verily the meter and test strip are working together properly, and that the test is performing correctly.
The Medisian Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabeles and their healthcare professionals in the review, and evaluation of glucose test results for effective controlling and managing blood glucose.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpan C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
13
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."