# K141410: Oragene DX Ogd-500.001

- Pathway: 510(k) (Traditional)
- Applicant: DNA Genotek, Inc.
- Decided: Feb 19, 2015 after 266 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.
3 later devices descend from it; 2 cite 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.

## Most influential descendants
- 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 OGD-500.001 is intended for use in the non-invasive collection of saliva samples. DNA from the saliva sample is isolated, stabilized, and suitable for over-the-counter use with FDA cleared, approved, or legally marketed exempt DNA carrier screening genotyping tests. Saliva samples collected using Oragene*Dx OGD-500.001 are stabilized and can be transported and/or stored long term at ambient conditions.

Source page: https://510kreport.com/device/K141410
Methodology: https://510kreport.com/methodology