# K192920: Oragene®•Dx

- Pathway: 510(k) (Traditional)
- Applicant: DNA Genotek, Inc.
- Decided: Jan 14, 2020 after 90 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: 4 generations back to K945952 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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.
- K141410: Oragene DX Ogd-500.001, DNA Genotek, Inc. (2015) Summary page 4.
- K152556: Oragene Dx, DNA Genotek, Inc. (2016) Summary page 4.

## Most influential descendants
- K212745: ORAcollect®•Dx (2022), 0 descendants of its own

## Indications for use
Oragene®•Dx is intended for use in the non-invasive collection of saliva samples for in vitro diagnostic testing of human DNA. 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 may be collected by a healthcare professional or non-healthcare professional, such as a lay user. Saliva samples collected using Oragene®•Dx are stabilized and isolated for use in downstream diagnostic testing applications. Saliva samples collected using Oragene®•Dx can be transported and/or stored long term at ambient conditions

Source page: https://510kreport.com/device/K192920
Methodology: https://510kreport.com/methodology