# K221802: iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)

- Pathway: 510(k) (Traditional)
- Applicant: Mawi Dna Technologies
- Decided: Apr 3, 2023 after 286 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 iSWAB-Respiratory Tract Sample Collection Media-Extraction Less collection device is intended for the stabilization and inactivation of upper respiratory and saliva human specimens suspected of containing SARS-CoV-2. This device can be used for the collection, transport, and storage of specimens at ambient temperature. Specimens collected in the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less collection device are suitable for use with legally marketed molecular diagnostic tests.

Source page: https://510kreport.com/device/K221802
Methodology: https://510kreport.com/methodology