# K212745: ORAcollect®•Dx

- Pathway: 510(k) (Traditional)
- Applicant: DNA Genotek, Inc.
- Decided: Oct 27, 2022 after 423 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: 5 generations back to K945952 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192920: Oragene®•Dx, DNA Genotek, Inc. (2020) Summary page 4.

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

Source page: https://510kreport.com/device/K212745
Methodology: https://510kreport.com/methodology