# K192957: VivaChek Blood Glucose and B-Ketone Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
- Decided: Jun 5, 2020 after 228 days
- Product code: JIN (Nitroprusside, Ketones (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K945887 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170463: KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System, I-Sens, Inc. (2018) Summary page 5.

## Indications for use
VivaChek™ Blood Glucose and β-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips (VKS01). The VivaChek™ Blood Glucose and β-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or β-ketone (beta-hydroxybutyrate) concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

Source page: https://510kreport.com/device/K192957
Methodology: https://510kreport.com/methodology