# K020740: Roche Online Theophylline

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 16, 2002 after 41 days
- Product code: KLS (Enzyme Immunoassay, Theophylline)
- Device class: 2
- Regulation: 21 CFR 862.3880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COBAS INTEGRA Theophylline assay: named in the summary without a submission number

## Indications for use
The Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of theophylline, a broncodilator, widely used to treat patients with asthma, apnea (temporary asphyxia), and other obstructive lung disecases. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

Source page: https://510kreport.com/device/K020740
Methodology: https://510kreport.com/methodology