# K192785: OptiScanner® 5000 Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Optiscan Biomedical Corporation
- Decided: Feb 5, 2020 after 128 days
- Product code: LZF (Pump, Infusion, Analytical Sampling)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951739 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162042: OptiScanner 5000 Glucose Monitoring System, Optiscan Biomedical Corp. (2017) Summary page 4.

## Indications for use
The OptiScanner® 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner® 5000 Glucose Monitoring System is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K192785
Methodology: https://510kreport.com/methodology