# K110074: HL 568 Self Monitoring Blood Glucose System, HL 568BA Self-Moniroting Blood Glucose System

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: May 25, 2012 after 501 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: 1 generation back to K062195 (2006). 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)
- K062195: Modification to One Touch Ultra Blood Glucose Monitoring System, Lifescan, Inc. (2006) Summary page 2.

## Indications for use
HL568 Self-Monitoring Blood Glucose (SMBG) System is self-test medical device and intended for single patient home-use to monitor the blood glucose (P-D-glucose) levels in quantitative measurement from fresh capillary whole blood obtained from the finger tip. It is intended for use outside the body (in vitro diagnostic use) by diabetics at home to measure the glucose concentration for aiding diabetes management. It is not intended for the diagnosis of or screening for diabetes mellitus. HL568 Self-Monitoring Blood Glucose (SMBG) System is intended to be used by a single person and should not be shared and it is also not intended for use on neonates and should be used with HL568 Blood glucose test strip and HL568 Control Solution. HUGS8 Blood glucose test strips are for use with the HL568 Blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip. HL568 Control Solutions are for use wit the HL568 Blood glucose meter and 11L568 Blood glucose test strips to check that the meter and test strips are working together properly and that the test is performing correctly. The device is capable of transferring the storage data to the connected personal computer (PC) via USH cable. In addition, HL568 Self-Monitoring Blood Glucose System is featured wit audio function; it could help the user to know the measured result by hearing but is not intended for visually impaired users.

Source page: https://510kreport.com/device/K110074
Methodology: https://510kreport.com/methodology