# K231013: DNA/RNA Shield SafeCollect Saliva Collection kit

- Pathway: 510(k) (Traditional)
- Applicant: Zymo Research
- Decided: Sep 28, 2023 after 171 days
- Product code: QBD (Microbial Nucleic Acid Storage And Stabilization Device)
- Device class: 2
- Regulation: 21 CFR 866.2950
- 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 DEN170029 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202641: DNA/RNA Shield Collection Tube, Zymo Research (2020) Summary page 4.

## Indications for use
The DNA/RNA Shield™ SafeCollect Saliva Collection Kit is intended for the collection, inactivation, stabilization, and transportation, of unprocessed saliva specimens suspected of containing SARS-CoV-2. The DNA/RNA Shield™ SafeCollect Saliva Collection Kit is intended to transport and store saliva specimens at ambient temperature (20-25°C) from the collection site to the laboratory. Specimens collected and preserved in a DNA/RNA Shield™ SafeCollect Saliva Collection kit sample collection tube are suitable for use with legally marketed molecular diagnostic devices.

Source page: https://510kreport.com/device/K231013
Methodology: https://510kreport.com/methodology