# K092603: Cobas Integra Glucose HK Gen 3 Assay

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Dec 4, 2009 after 101 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
Longest line of descent: 3 generations back to K842280 (1984). 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)
- K061048: Cobas Integra Glucose HK Gen. 3 Test System, Roche Diagnostics Corp. (2006) Summary page 2.

## Indications for use
In vitro test for the quantitative determination Of glucose in serum, plasma, urine and cerebrospinal fluid (CSF). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and pancreatic islet cell tumors.

Source page: https://510kreport.com/device/K092603
Methodology: https://510kreport.com/methodology