# K123271: Abbott Phenobarbital Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Apr 26, 2013 after 189 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: 2 generations back to K913190 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993031: Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54, Syva Co. (2000) Summary page 3.

## Indications for use
The Abbott Phenobarbital assay is for in vitro diagnostic use for the quantitative measurement of phenobarbital in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.

Source page: https://510kreport.com/device/K123271
Methodology: https://510kreport.com/methodology