# K252323: cobas pulse blood glucose monitoring system

- Pathway: 510(k) (Dual Track)
- Applicant: Roche Diagnostics
- Decided: Jun 12, 2026 after 322 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: 4 generations back to K060345 (2006). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181043: StatStrip Glucose Hospital Meter System, Nova Biomedical Corporation (2018) Summary page 5.

## Indications for use
The cobas® pulse blood glucose monitoring system consists of the cobas® pulse instrument and the cobas® GLU test strips. This system is intended for in vitro diagnostic, point of care, multiple-patient use within professional healthcare settings, including patients receiving intensive medical intervention/therapy. The cobas® GLU test strips provide an in vitro diagnostic test that quantitatively measures glucose in venous whole blood, arterial whole blood, neonate arterial whole blood, or neonate heel stick whole blood samples, on the cobas® pulse system. For neonate heel stick, the system should only be used with single-use, auto-disabling lancing devices. This system is not intended for use with capillary finger stick, neonate cord blood specimens or neonate venous specimens. This system is not intended for screening or diagnosis of diabetes, but is indicated for use in determining dysglycemia.

Source page: https://510kreport.com/device/K252323
Methodology: https://510kreport.com/methodology