# K061048: Cobas Integra Glucose HK Gen. 3 Test System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: May 17, 2006 after 30 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: 2 generations back to K842280 (1984). 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)
- K972250: Roche Cobas Integra Reagent Cassettes & Ancillary Reagents, Roche Diagnostic Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- K092603: Cobas Integra Glucose HK Gen 3 Assay (2009), 0 descendants of its own

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

Source page: https://510kreport.com/device/K061048
Methodology: https://510kreport.com/methodology