# K213061: SuperCheck Pro Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Ok Biotech Co., Ltd.
- Decided: Oct 7, 2022 after 380 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: 3 generations back to K070585 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171785: WowGoHealth Blood Glucose Monitoring System, Biotest Medical Corporation (2017) Summary page 4.

## Indications for use
The SuperCheck Pro Blood Glucose Monitoring System is comprised of the SuperCheck Pro Blood Glucose Meter and SuperCheck Pro Blood Glucose Test Strips. The SuperCheck Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, forearm, upper arm, calf, thigh, or palm. It is intended to be used by a single person and should not be shared. The SuperCheck Pro Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates. Alternative site testing should be done only during steady-state conditions (when blood glucose is not changing rapidly).

Source page: https://510kreport.com/device/K213061
Methodology: https://510kreport.com/methodology