# K111456: Medisign Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Empecs Medical Device Co., Ltd.
- Decided: Feb 28, 2012 after 279 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000318 (2000). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053529: Onetouch Ultra 2 Blood Glucose Monitoring System, Lifescan, Inc. (2006) Summary page 1.
- K022769: Lifescan Onetouch Ultra Control Solution, Bionostics, Inc. (2002) Summary page 1.

## Most influential descendants
- K152534: 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 (2017), 0 descendants of its own
- K133260: Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring System (2014), 0 descendants of its own

## 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- MMIOOO test strip is to be used with Medisign-'MMl000 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign" MM 1000 test strips and associated meter 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. Medisign T m Glucose Control Solutions are for use with Medisign Tm Brand Blood Glucose Meters and MedisignIN 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, MesisignJN Glucose Control Solutions are for in vitro diagnostic 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 Medisignm MMlIOO test strip is to be used with Medisign- MMlIOO Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign- MMII0O test strips and associated meter are for use in fingertip, forearm, and palmn 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. Medlisign m ' Glucose Control Solutions are for use with Medisig" Brand Blood Glucose Meters and Medisign Test Strips to check that the meter and test strips are working together properly. MedisignT m Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home, Mesisign m Glucose Control Solutions are for in vitro diagnostic 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- MM 1200 test strip is to be used with Medisignm MM 1200 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisigiw' MM 1200, test strips and associated meter 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. Medisign m Glucose Control Solutions are for use with Medisign~v Brand Blood Glucose Meters and Medisign TM Test Strips to check that the meter and test strips are working together properly. Medisign T m Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home, Mesisign~N Glucose Control Solutions are for in vitro diagnostic 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-' MMIOOO Multi Blood Glucose Test strip is to be used with Medisignm, MM1000 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisignm MIOOO00 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~m Glucose Control Solutions are for use with Medisign~m Brand Blood Glucose Meters and Medisign " Test Strips to check that the meter and test strips are working together properly. Medisign~m Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mesisign1 N Glucose Control Solutions are for in vitro diagnostic 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"- MM 1100 Multi Blood Glucose Test strip is to be used with Medisign-' MMI 100 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign-MMII100 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 m Glucose Control Solutions are for use with Medisign' m Brand Blood Glucose Meters and MedisignI m Test Strips to check that the meter and test strips are working together properly. Medisign m Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mesisign'm Glucose Control Solutions are for in vitro diagnostic 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 systemi can only be used during stead-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system. The MedisignM MMv1200 Multi Blood Glucose Test strip is to be used with Medisignm MM 1200 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 T m Glucose Control Solutions are for use with Medisignm Brand Blood Glucose Meters and Medisig1Y'm Test Strips to check that the meter and test strips are working together properly. Medisign m Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mvesisign' Glucose Control Solutions are for in vitro diagnostic use.

Source page: https://510kreport.com/device/K111456
Methodology: https://510kreport.com/methodology