# K201849: eNAT molecular collection and preservation medium

- Pathway: 510(k) (Traditional)
- Applicant: Copan Italia Spa
- Decided: Sep 17, 2020 after 73 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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 6.

## Most influential descendants
- K212878: Sample preservation solution (2024), 0 descendants of its own
- K220059: Biosci™ Inactivated Transport Medium, Biosci™ ITM (2023), 0 descendants of its own

## Indications for use
Copan eNAT- molecular collection and preservation medium- is intended for the stabilization, transportation and inactivation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA. eNAT- molecular collection and preservation medium- is intended for use with compatible molecular assays.

Source page: https://510kreport.com/device/K201849
Methodology: https://510kreport.com/methodology