# K101037: EG V1 (BL) Self Monitoring Glucose Test System Model: EPS10017

- Pathway: 510(k) (Traditional)
- Applicant: Eps Bio Technology Corp.
- Decided: May 23, 2011 after 404 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.
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)
- K062058: Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080, Bayer Healthcare (2006) Summary page 2.

## Indications for use
The EG V1 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to mbnitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The system consists of the EG V1 Pro meter and the EG Pro Test Strips. The EG V1 Pro meter only is used with the EG Pro Test Strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from the fingertip. EG Glucose Control Solution For use with the EG Vi Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results. The EG V1 (BL) Self Monitoring Blood Glucose Test System is intended for the quantiatative measurement of glucose in fresh capillary whole blood from the fingertip, palm or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter[OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions. The system consists of the EG V1 (BL) meter and the EG V1 Test Strips. The EG V1 (BL) meter only is used with the EG V1 Test Strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from the fingertip, palm, or forearm. EG Glucose Control Solution For use with the EG Vi Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K101037
Methodology: https://510kreport.com/methodology