# K071644: Online Phenobarbital, Model 03016757190 & 03510620

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 12, 2007 after 89 days
- Product code: DLZ (Enzyme Immunoassay, Phenobarbital)
- Device class: 2
- Regulation: 21 CFR 862.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951595 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 1.

## Indications for use
The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital.

Source page: https://510kreport.com/device/K071644
Methodology: https://510kreport.com/methodology