# K202641: DNA/RNA Shield Collection Tube

- Pathway: 510(k) (Traditional)
- Applicant: Zymo Research
- Decided: Dec 14, 2020 after 94 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: 1 generation back to DEN170029 (2018). 1 ancestor in all.
7 later devices descend from it; 6 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170029: PrimeStore MTM, Longhorn Vaccines and Diagnostics, LLC (2018) Summary page 4.

## Most influential descendants
- K223497: Spectrum Saliva Collection Device (2023), 1 descendant of its own
- K242820: Puritan PurSafe Plus Collection and Transport System (2025), 0 descendants of its own
- K240797: PPH Saliva Collection Kit (2024), 0 descendants of its own
- K221547: InActiv Blue (2024), 0 descendants of its own
- K231013: DNA/RNA Shield SafeCollect Saliva Collection kit (2023), 0 descendants of its own

## Indications for use
The DNA/RNA Shield™ collection tube is intended for the stabilization and inactivation of upper and lower respiratory human specimens suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens at ambient temperatures (20-25°C). Specimens collected and stored in a DNA/RNA Shield™ collection tube are suitable for use with legally marketed molecular diagnostic devices.

Source page: https://510kreport.com/device/K202641
Methodology: https://510kreport.com/methodology