# K121224: Genesis Health Technologies Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Sep 19, 2012 after 152 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- 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: 1 generation back to K101631 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101631: Fora GD20 Blood Glucose Monitoring System, U-Rught TD-4252D Blood Glucose Monitoring System, Taidoc Technology Corporation (2011) Summary page 2.

## Indications for use
The Genesis Health 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, and the upper-arm. It is intended for use by people wit 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. This system is intended to be used by a single person and should not be shared. The Genesis Health Technologies test strips are for use with the Genesis Health Technologies meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm and upper arm. The alternative site testing in the Genesis Health Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions. The Genesis Health Technologies control solutions are for use with the Genesis Health Blood Glucose meter and test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K121224
Methodology: https://510kreport.com/methodology