# K081231: Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33, 1P33

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 26, 2008 after 148 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 K940596 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940596: Axsym Phenobarbital, Abbott Laboratories (1994) Summary page 2.

## Most influential descendants
- K210858: VITROS Chemistry Products PHBR Slides (2021), 0 descendants of its own

## Indications for use
The ARCHITECT iPhenobarbital assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenobarbital, an anticonvulsant and sedative-hypnotic drug, in human serum or plasma on the ARCHITECT i System with STATprotocol capability. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy. The ARCHITECT iPhenobarbital Calibrators are for the calibration of the ARCHITECT i System with STA T protocol capability when used for the quantitative determination of phenobarbital in human serum or plasma.

Source page: https://510kreport.com/device/K081231
Methodology: https://510kreport.com/methodology