# K170316: Alinity C Glucose Reagent Kit, Alinity C System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 19, 2017 after 260 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K872494 (1987). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060383: Glucose, Abbott Laboratories (2006) Summary page 6.
- K980367: Aeroset System, Abbott Laboratories (1998) Summary page 6.

## Most influential descendants
- 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

## Recalls of this device
- Nov 13, 2025 · Class II · Z-0961-2026: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the A

## Indications for use
The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

Source page: https://510kreport.com/device/K170316
Methodology: https://510kreport.com/methodology