# K911056: DU Pont Dimension (R) Phenytoin (PTN) Method

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Apr 3, 1991 after 26 days
- Product code: DIP (Enzyme Immunoassay, Diphenylhydantoin)
- Device class: 2
- Regulation: 21 CFR 862.3350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062024: Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge (2006), 0 descendants of its own

## Recalls of this device
- Sep 24, 2014 · Class II · Z-0148-2015: Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN ass

Source page: https://510kreport.com/device/K911056
Methodology: https://510kreport.com/methodology