# K123087: Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio AC500 AC800 Pro Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Tyson Bioresearch, Inc.
- Decided: Jun 18, 2013 after 260 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: 7 generations back to K964630 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101543: Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200, Tyson Bioresearch, Inc. (2011) Summary page 4.

## Indications for use
The TysonBio AC500 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 TysonBio AC500 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio AC500 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 TysonBio AC500 Blood Glucose Monitoring System 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 is not changing rapidly). The TysonBio AC500 Test Strips are for use with the TysonBio AC500 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC500 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results. The TysonBio AC800 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 TysonBio AC800 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio AC800 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 TysonBio AC800 Blood Glucose Monitoring System 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 is not changing rapidly). The TysonBio AC800 contains a voice function but this function is not intended for users with impaired vision. The TysonBio AC800 Test Strips are for use with the TysonBio AC800 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio' AC500/AC800 Control Solutions is for use on the TysonBio AC800 Blood Glucose Systems to check that the meter and test strips are working together properly and providing accurate results. The TysonBio AC500 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC500 Pro 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 TysonBio AC500 Pro Blood Glucose Monitoring System 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 is not changing rapidly). The TysonBio AC500 Pro Blood Glucose Test Strips are for use with the TysonBio AC500 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC500 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results. The TysonBio AC800 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC800 Pro 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 TysonBio AC800 Pro Blood Glucose Monitoring System 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 is not changing rapidly). The TysonBio AC800 Pro contains a voice function but this function is not intended for users with impaired vision. The TysonBio AC800 Pro Blood Glucose Test Strips are for use with the TysonBio AC800 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC800 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

Source page: https://510kreport.com/device/K123087
Methodology: https://510kreport.com/methodology