# K201551: KetoSens BT Blood B-Ketone Monitoring System

- Pathway: 510(k) (Special)
- Applicant: I-Sens, Inc.
- Decided: Sep 9, 2020 after 92 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The KetoSens BT Blood β-Ketone Monitoring System is intended for the quantitative measurement of β-Ketone (betahydroxybutyrate) level in capillary whole blood drawn from the fingertip. The KetoSens BT Blood β-Ketone Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of ketoacidosis control. The system is not intended for use in the diagnosis of or screening for ketoacidosis 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 BT Blood β-Ketone Meter to quantitatively measure Blood β-Ketone in capillary whole blood samples drawn from the finger.

Source page: https://510kreport.com/device/K201551
Methodology: https://510kreport.com/methodology