# K082618: Ultra Trak Pro Blood Glucose Monitoring System, Model TD-455

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Oct 7, 2008 after 28 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The UltraTRAK PRO Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arn, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in the UltraTRAK PRO Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Source page: https://510kreport.com/device/K082618
Methodology: https://510kreport.com/methodology