# K935047: Auto Delfia

- Pathway: 510(k) (Traditional)
- Applicant: Wallac OY
- Decided: May 23, 1994 after 214 days
- Product code: KHO (Fluorometer, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K042425: Autodelfia Neonatal 17A-OH-Progesterone Kit (2004), 4 descendants of its own
- K081922: Autodelfia Neonatal 17A-OH-Progesterone Kit (2009), 1 descendant of its own
- K100682: GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001U (2010), 0 descendants of its own
- K090846: GSP Instrument and GSP Neonatal HTSH Kit (2009), 0 descendants of its own
- K060452: Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015XX-Ecah (2007), 0 descendants of its own

## Recalls of this device
- Dec 21, 2016 · Class III · Z-1102-2017: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
- Dec 21, 2016 · Class III · Z-1101-2017: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
- Dec 21, 2016 · Class III · Z-1100-2017: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Source page: https://510kreport.com/device/K935047
Methodology: https://510kreport.com/methodology