# K152556: Oragene Dx

- Pathway: 510(k) (Traditional)
- Applicant: DNA Genotek, Inc.
- Decided: May 26, 2016 after 261 days
- Product code: OYJ (Dna Specimen Collection, Saliva)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945952 (1995). 4 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K110701: Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500, DNA Genotek, Inc. (2011) Summary page 4.

## Most influential descendants
- K192920: Oragene®•Dx (2020), 1 descendant of its own
- K212745: ORAcollect®•Dx (2022), 0 descendants of its own

## Indications for use
Oragene-Dx devices are intended for use in the non-invasive collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva may be collected by spitting directly into the Oragene-Dx container or may be transferred into the Oragene:Dx container using a sponge. Saliva samples collected using Oragene'Dx are stabilized and can be transported and/or stored long term at ambient conditions.

Source page: https://510kreport.com/device/K152556
Methodology: https://510kreport.com/methodology