# 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

- Pathway: 510(k) (Special)
- Applicant: Tianjin Empecs Medical Device Co., Ltd.
- Decided: Mar 21, 2017 after 564 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: 3 generations back to K000318 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111456: Medisign Blood Glucose Monitoring System, Tianjin Empecs Medical Device Co., Ltd. (2012) Summary page 11.

## Indications for use
Medisign MM1000 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). The Medisign MM1000 Blood Glucose Test Strips are to be used for monitoring glucose concentration 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 (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). The Smart Diabetes Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use. Smart Diabetes Glucose Control Solutions are intended for use with the Smart Diabetes Bluetooth meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together. 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 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 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. 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 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 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. 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 Medisign MM1200 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1200 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use. Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (in-vitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system. The Smart Diabetes Pro Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Pro Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use. Smart Diabetes Glucose Control Solutions are for use with both the Smart Diabetes Bluetooth Pro meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.

Source page: https://510kreport.com/device/K152534
Methodology: https://510kreport.com/methodology