# K953847: Roche Reagent for Glucose

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Feb 13, 1996 after 181 days
- Product code: CFR (Hexokinase, Glucose)
- 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K060383: Glucose (2006), 3 descendants of its own
- K170316: Alinity C Glucose Reagent Kit, Alinity C System (2017), 1 descendant of its own
- K252357: Glucose2 (2025), 0 descendants of its own
- K230790: Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (2023), 0 descendants of its own
- K062118: Pointe 360 (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K953847
Methodology: https://510kreport.com/methodology