# K152464: ORAcollect.Dx

- Pathway: 510(k) (Traditional)
- Applicant: DNA Genotek, Inc.
- Decided: May 26, 2016 after 269 days
- Product code: OYJ (Dna Specimen Collection, Saliva)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Recalls of this device
- Feb 18, 2022 · Class II · Z-0981-2022: Evaporation of stabilizing liquid reducing shelf life.

## Indications for use
ORAcollectDx is 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 samples collected using ORAcollect*Dx are stabilized and can be transported and/or stored long term at ambient conditions.

Source page: https://510kreport.com/device/K152464
Methodology: https://510kreport.com/methodology