# K141829: Glucovitaal H1A Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Ceragem Medisys, Inc.
- Decided: Sep 24, 2014 after 79 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: 2 generations back to K062058 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131727: Cera-Chek 1070 Blood Glucose Monitoring System, Ceragem Medisys, Inc. (2014) Summary page 4.

## Indications for use
The GlucoVitaal H1A 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 fingertip, forearm, upper arm, palm, thigh, or calf. The GlucoVitaal H1A 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 GlucoVitaal H1A 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 GlucoVitaal H1A Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GlucoVitaal H1A Blood Glucose Test Strips are for use with the GlucoVitaal H1A 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 GlucoVitaal H1A Glucose Control Solution is for use with the GlucoVitaal H1A Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K141829
Methodology: https://510kreport.com/methodology