# K221547: InActiv Blue

- Pathway: 510(k) (Traditional)
- Applicant: Fertipro NV
- Decided: Jun 11, 2024 after 746 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
InActiv Blue is intended for the stabilization, transportation and inactivation of upper respiratory specimens suspected of containing SARS-CoV-2. These devices can be used for collection, transport and storage of specimens at refrigerated (2-8°C) or ambient temperatures (20-25°C). SARS-CoV-2 RNA in the specimens is stabilized for 7 days at these specified temperatures. Specimens collected and stored in an InActiv Blue collection tube are suitable for use with legally marketed molecular diagnostic devices.

Source page: https://510kreport.com/device/K221547
Methodology: https://510kreport.com/methodology