# K162564: Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Empecs Medical Device Co., Ltd.
- Decided: Jun 7, 2017 after 266 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: 5 generations back to K053529 (2006). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150214: OneTouch Verio Flex Blood Glucose Monitoring System, Lifescan Europe (2015) Summary page 10.

## Indications for use
The Medisign GH81 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly). The Medisign GH81 Blood Glucose Monitoring System is comprised of the Medisign GH81 Blood Glucose Meter and Medisign GH81 Blood Glucose Test Strips. The Medisign GH82 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly). The Medisign GH82 Blood Glucose Monitoring System is comprised of the Medisign GH82 Blood Glucose Meter and Medisign GH82 Blood Glucose Test Strips. The Medisign GH83 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly). The Medisign GH83 Blood Glucose Monitoring System is comprised of the Medisign GH83 Blood Glucose Meter and Medisign GH83 Blood Glucose Test Strips. The Medisign GH81 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. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly). The Medisign GH81 BT Blood Glucose Monitoring System is comprised of the Medisign GH81 BT Blood Glucose Meter and Medisign GH81 Blood Glucose Test Strips. The Medisign GH82 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. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly). The Medisign GH82 BT Blood Glucose Monitoring System is comprised of the Medisign GH82 BT Blood Glucose Meter and Medisign GH82 Blood Glucose Test Strips. The Medisign GH83 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. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly). The Medisign GH83 BT Blood Glucose Monitoring System is comprised of the Medisign GH83 BT Blood Glucose Meter and Medisign GH83 Blood Glucose Test Strips.

Source page: https://510kreport.com/device/K162564
Methodology: https://510kreport.com/methodology