# K063684: Cobas Lithium

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 21, 2008 after 465 days
- Product code: NDW (Assay, Porphyrin, Spectrophotometry, Lithium)
- Device class: 2
- Regulation: 21 CFR 862.3560
- 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 K912649 (1991). 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)
- K963627: (Modified Version) Integra Ion Selective Electrode (Ise) Module, Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Indications for use
In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of lithium are used as an aid in the management of patients taking lithium for the treatment of mental disturbances such as manic-depressive illness (bipolar disorder).

Source page: https://510kreport.com/device/K063684
Methodology: https://510kreport.com/methodology