# K080696: Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and 1P34-01

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 11, 2008 after 183 days
- Product code: DIP (Enzyme Immunoassay, Diphenylhydantoin)
- Device class: 2
- Regulation: 21 CFR 862.3350
- 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 K935375 (1994). 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)
- K935375: Axsym Phenytoin Assay, Abbott Laboratories (1994) Summary page 2.

## Indications for use
The ARCHITECT iPhenytoin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenytoin, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of phenytoin to help ensure appropriate therapy. The ARCHITECT iPhenytoin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of phenytoin in human serum or plasma.

Source page: https://510kreport.com/device/K080696
Methodology: https://510kreport.com/methodology