# K201396: Finetest Lite Smart Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Osang Healthcare Co., Ltd.
- Decided: Oct 16, 2020 after 141 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 K062058 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182286: Oh'Care Lite Smart Blood Glucose Monitoring System, Osang Healthcare Co., Ltd. (2018) Summary page 4.

## Indications for use
The Finetest Lite Smart Blood Glucose Monitoring System is comprised of the Finetest Lite Smart meter and the Finetest Lite Smart Blood Glucose Test Strips. The Finetest Lite Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Finetest Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Finetest Lite Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady—state times (when glucose is not changing rapidly). The Finetest Lite Smart Blood Glucose Test Strips are for use with the Finetest Lite Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

Source page: https://510kreport.com/device/K201396
Methodology: https://510kreport.com/methodology