# K170079: Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Tyson Bioresearch, Inc.
- Decided: Oct 6, 2017 after 269 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: 4 generations back to K010362 (2001). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133741: ACCU-CHEK Performa Blood Glucose Monitoring System, Roche Diagnostics (2014) Summary page 7.

## Most influential descendants
- K182046: Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System (2018), 0 descendants of its own
- K182047: Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System (2018), 0 descendants of its own

## Indications for use
The Tyson Bio HT100-B Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The Tyson Bio HT100-B Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-B Blood Glucose Meter and Tyson Bio HT100-B Blood Glucose Test Strip. The Tyson Bio HT100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The Tyson Bio HT100 Blood Glucose Monitoring System is comprised of the Tyson Bio HT100 Blood Glucose Meter and Tyson Bio HT100 Blood Glucose Test Strip.

Source page: https://510kreport.com/device/K170079
Methodology: https://510kreport.com/methodology