# K200788: Assure Titanium Blood Glucose Monitoring System

- Pathway: 510(k) (Dual Track)
- Applicant: Arkray, Inc.
- Decided: May 23, 2022 after 788 days
- Product code: PZI (Prescription Use Blood Glucose Meter For Near-Patient Testing)
- 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: 2 generations back to K060345 (2006). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132121: Statstrip Glucose Hospital Meter System, Nova Biomedical Corporation (2014) Summary page 5.

## Most influential descendants
- K221349: XPER Technology PREMIUM Pro Blood Glucose Monitoring System (2024), 0 descendants of its own

## Indications for use
The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test strips. The system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing or skilled nursing facilities, for multiple patient use. This system should only be used with single use, auto-disabling lancing devices for drawing finger stick capillary blood. The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The system is not intended for use in acute care or hospital settings. The system is not intended for neonatal use. The system is for prescription use only.

Source page: https://510kreport.com/device/K200788
Methodology: https://510kreport.com/methodology