# K093764: SOLOV2 Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Biotest Medical Corp.
- Decided: Mar 2, 2010 after 85 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: 4 generations back to K042005 (2004). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091815: Supercheck 1 Blood Glucose Monitoring System, Model 6268, Biotest Medical Corp. (2009) Summary page 1.

## Most influential descendants
- K123559: Solusmobile Blood Glucose Managment System (2013), 0 descendants of its own

## Indications for use
The SoloV2 TmBlood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes MellitUs at homfe and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains a speaking function that provides audible test results for users with low vision.

Source page: https://510kreport.com/device/K093764
Methodology: https://510kreport.com/methodology