# K121433: Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood Glucose Monitoring Systems

- Pathway: 510(k) (Traditional)
- Applicant: Hmd Biomedical, Inc.
- Decided: Feb 14, 2013 after 276 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: 4 generations back to K070472 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101509: U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272  Blood Glucose Monitoring System, Taidoc Technology Corporation (2011) Summary page 1.

## Indications for use
The GoodLife CS-200 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 only. The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GoodLife CS-200 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 GoodLife CS-200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife KP Blood Glucose Test Strips are for use with the GoodLife CS-200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips. It 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 a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife KP Professional Blood Glucose Test Strip is for use with the GoodLife CS-200 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in venous or arterial whole blood or fresh capillary drawn from the fingertips.

Source page: https://510kreport.com/device/K121433
Methodology: https://510kreport.com/methodology