# K221349: XPER Technology PREMIUM Pro Blood Glucose Monitoring System

- Pathway: 510(k) (Dual Track)
- Applicant: Taidoc Technology Corporation
- Decided: Nov 19, 2024 after 925 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: 3 generations back to K060345 (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)
- K200788: Assure Titanium Blood Glucose Monitoring System, Arkray, Inc. (2022). Cleared while this submission was under review Summary page 5.

## Indications for use
The XPER Technology PREMIUM Pro Blood Glucose Monitoring System consists of the XPER Technology PREMIUM Pro Blood Glucose Meter and XPER Technology PREMIUM Pro Blood Glucose Test Strips. The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in fresh capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories. The system should only be used with single-use, auto-disabling lancing devices when performing a fresh capillary whole blood sample from the fingertip. 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 on patients receiving intensive medical intervention/therapy. The system is not intended for use in acute care, nursing facilities, skilled nursing facilities or hospital settings. The system is not intended for use on neonates.

Source page: https://510kreport.com/device/K221349
Methodology: https://510kreport.com/methodology