# K170463: KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: I-Sens, Inc.
- Decided: Apr 13, 2018 after 422 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: 7 generations back to K945887 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091547: Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos, Nova Biomedical Corp. (2010) Summary page 7.

## Most influential descendants
- K192957: VivaChek Blood Glucose and B-Ketone Monitoring System (2020), 0 descendants of its own

## Indications for use
KetoSens Blood β-Ketone Monitoring System is intended to be used for the quantitative measurement of β-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood β-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared. The KetoSens Blood β-Ketone Test Strips work with the KetoSens Blood β-Ketone Meter to quantitatively measure Blood β-Ketone in capillary whole blood samples drawn from the fingertip. KetoSens Multi Blood β-Ketone Monitoring System is intended to be used for the quantitative measurement of β-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood β-Ketone Monitoring System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with single-use, auto-disabling lancing devices. The KetoSens Multi Blood β-Ketone Test Strips work with the KetoSens Multi Blood β-Ketone Meter to quantitatively measure Blood β-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.

Source page: https://510kreport.com/device/K170463
Methodology: https://510kreport.com/methodology