# K222613: ARX Liquid Amies Collection & Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Arx Sciences, Inc.
- Decided: Mar 27, 2024 after 575 days
- Product code: LIO (Device, Specimen Collection)
- Device class: 1
- Regulation: 21 CFR 866.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K854986 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120846: Transport Culture Medium Device, Puritan Medical Products, LLC (2012) Summary page 4.

## Indications for use
The ARX Liquid Amies Collection & Transport System (ARX) is intended for use in the collection of clinical specimens (i.e., nasal secretion/wash; lachrymal secretion/tears; auricular secretion/cerumen; urethral, rectal, or vaginal swab; wound/abscess material) potentially containing aerobic, anaerobic, and fastidious bacteria and their transport at 2-80 C or 25-30 0 C from the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens of nasal, lachrymal, ceruminous, vaginal, urethral, rectal, and wound/abscess origin are processed using standard clinical laboratory operating procedures for bacterial culture.

Source page: https://510kreport.com/device/K222613
Methodology: https://510kreport.com/methodology