# K131727: Cera-Chek 1070 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Ceragem Medisys, Inc.
- Decided: Feb 28, 2014 after 261 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 K062058 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062058: Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080, Bayer Healthcare (2006) Summary page 1.

## Most influential descendants
- K141829: Glucovitaal H1A Blood Glucose Monitoring System (2014), 0 descendants of its own

## Indications for use
The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in flesh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The CERA-CHEK 1070 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 controls. The CERA-CHEK 1070 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The CERA-CHEK 1070 Blood Glucose Test Strips are for use with the CERA-CHEK 1070 Blood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The CERA-CHEK 1070 Control Solution is for use with the CERA-CHEK 1070 Blood Glucose Test Meter and Test strips as a quality control check to verif that the meter and test strips are working together properly and that the test is performing correctly. The CERA-CHEK Diabetes Management Software is PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose results for effective diabetes management. It is intended for use as an accessory to compatible CERAGEM MEDISYS blood glucose monitoring systems. The CERA-CHEK Diabetes Management Software's language is English.

Source page: https://510kreport.com/device/K131727
Methodology: https://510kreport.com/methodology