# K133509: Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose Monitoring System,Smartest Persona II Bloo

- Pathway: 510(k) (Special)
- Applicant: Biotest Medical Corp.
- Decided: Feb 21, 2014 after 99 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 K042005 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100560: Easy Talk Blood Glucose Monitoring System Model: 6277, Biotest Medical Corp. (2010) Summary page 6.

## Indications for use
The Easy Plus 11 Blood Glucose Monitoring System Model 6276-S is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus 11 Blood Glucose Monitoring System Model 6276-S is intended to be used by a single person and should not be shared. The Easy Plus 11 Blood Glucose Monitoring System Model 6276-S is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Easy Plus 11 Blood Glucose Monitoring System Model 6276-S should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly). The Easy Plus 11 Test Strips are for use with the Easy Plus 11 Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus 11 Control Solutions are for use with the Easy Plus 11Blood Glucose Monitoring System Model 6276-S as a quality control check to verify that the meter and test strips are working together properly. The Easy Plus 11 Multi Blood Glucose Monitoring System Model 6276-U is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus 11Multi Blood Glucose Monitoring System Model 6276-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a profession healthcare setting as an aid to monitor the effectiveness of a diabetes control programi. This system should only be used with single-use, auto-disabling lancets. The Easy Plus 11 Multi Blood Glucose Monitoring System Model 6276-M should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly). The Easy Plus 11 Multi Test Strips are for use with the Easy Plus 11 Blood Glucose Multi Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus 11 Multi Control Solutions are for use with the Easy Plus 11 Multi Blood Glucose Monitoring System Model 6276-M as aquality control check to verify that the meter and test strips are working together properly. The Smartest Persona 11 Blood Glucose Monitoring System Model 6276-S is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona II Blood Glucose Monitoring System Model 6276-S is intended to be used by a single person and should not be shared. The Smartest Persona 11 Blood Glucose Monitoring System Model 6276-S is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control. The Smartest Persona 11 Blood Glucose Monitoring System Model 6276-S should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly). The Smartest Persona 11 Test Strips are for use with the Smartest Persona 11 Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona 11 Control Solutions are for use with the Smartest Persona 11Blood Glucose Monitoring System Model 6276-S asa quality control check to verify that the meter and test strips are working together properly. The Smartest Persona 11 Multi Blood Glucose Monitoring System Model 6276-M is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona 11 Multi Blood Glucose Monitoring System Model 6276-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a profession healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets. The Smartest Persona 11 Multi Blood Glucose Monitoring System Model 6276-M should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly). The Smartest Persona 11 Multi Test Strips are for use with the Smartest Persona 11 Blood Glucose Multi Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona 11 Multi Control Solutions are for use with the Smartest Persona 11 Multi Blood Glucose Monitoring System Model 6276-M as a quality control check to verify that the meter and test strips are working together properly.

Source page: https://510kreport.com/device/K133509
Methodology: https://510kreport.com/methodology