# K061301: Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Copan Diagnostics, Inc.
- Decided: Jun 23, 2006 after 44 days
- Product code: JTW (System, Transport, Aerobic)
- 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: 2 generations back to K854986 (1986). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854986: BBL Port-a-Cul Aerobic Transport Sys, Modified Stu, Bd Becton Dickinson Vacutainer Systems Preanalytic (1986) Summary page 1.
- K972448: Copan Venturi Transystem Amies Medium Without Charcoal, Copan Italia Spa (1997) Summary page 1.
- K946287: Copan Venturi Transystem Amies Medium Without Charcoal, Copan Diagnostics, Inc. (1995) Summary page 1.

## Most influential descendants
- K120846: Transport Culture Medium Device (2012), 1 descendant of its own
- K121039: Copan Mswab Collection, Transport and Preservation System (2012), 1 descendant of its own
- K222613: ARX Liquid Amies Collection & Transport System (2024), 0 descendants of its own
- K211707: BioTeke Sterile Disposable Virus Sampling Kit (2022), 0 descendants of its own

## Indications for use
Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory. In the laboratory, ESwab specimens are processed using standard clinical laboratory operating procedures for bacterial culture.

Source page: https://510kreport.com/device/K061301
Methodology: https://510kreport.com/methodology