# K131013: Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Oct 17, 2013 after 189 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: 11 generations back to K945887 (1995). 33 ancestors in all.
No later device cites it as a predicate yet.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122435: Nova One Blood Glucose Monitor, Nova Biomedical Corporation (2012) Summary page 1.

## Indications for use
The FOCUS Blood Glucose Monitoring System Is Intended for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or forearm. Intended to be used by a single patient and should not be shared. Intended for self-testing outside the body by people with diabetes meliltus as an aid to monitor the effectiveness of diabetes control. Alternative site testing on the forearm can be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates. FOCUS Blood Glucose Test Strips are used only with FOCUS Meters to quantitatively measure whole blood glucose in fresh, human capillary whole blood taken from the fingertip or forearm. FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and Test Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. The FOCUS PRO Blood Glucose Monitoring System is Intended for the quantitative measurement of glucose in venious and arterial whole blood and in fresh capillary whole blood obtained from the fingertip or forearm. Intended for testing outside the body (in vitro diagnostic use) for multi-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with sing-use, auto-disabling lancing devices. Aternative site testing on the forearm should be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not Intended for use on neonates. FOCUS PRO Blood Glucose Test Strips are used only with FOCUS PRO Meters for the quantitative measurement of glucose in venious and arterial whole blood and Infresh capillary whole blood taken from the fingertip or forearm. FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and Test Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test Is performing correctly.

Source page: https://510kreport.com/device/K131013
Methodology: https://510kreport.com/methodology