# K221664: CLEARinse CTS Specimen Collection and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Aardvark Medical, Inc.
- Decided: Jul 3, 2023 after 390 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
CLEARinse CTS is intended to collect and transport clinical nasal wash aspirate specimens that may contain influenza A or influenza B virus, by health care professionals, from the collection site to a laboratory or testing site. CLEARinse CTS specimens are suitable for use with legally marketed lateral flow immunoassays and molecular assays. CLEARinse CTS is for professional in-vitro diagnostic use.

Source page: https://510kreport.com/device/K221664
Methodology: https://510kreport.com/methodology