# K110701: Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500

- Pathway: 510(k) (Traditional)
- Applicant: DNA Genotek, Inc.
- Decided: Dec 2, 2011 after 263 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: 2 generations back to K945952 (1995). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972075: Vacutainer Brand PPT Plasma Preparation Tube, Becton Dickinson Vacutainer Systems (1998) Summary page 1.

## Most influential descendants
- K141410: Oragene DX Ogd-500.001 (2015), 3 descendants of its own
- K152556: Oragene Dx (2016), 2 descendants of its own
- K192920: Oragene®•Dx (2020), 1 descendant of its own
- K212745: ORAcollect®•Dx (2022), 0 descendants of its own
- K192947: AncestryDNA Saliva Collection Kit (2020), 0 descendants of its own

## Indications for use
Oragene.Dx is intended for use in the non-invasive collection of saliva samples. 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 OrageneDx are stabilized and can be transported and/or stored long term at ambient conditions.

Source page: https://510kreport.com/device/K110701
Methodology: https://510kreport.com/methodology