# K972448: Copan Venturi Transystem Amies Medium Without Charcoal

- Pathway: 510(k) (Traditional)
- Applicant: Copan Italia Spa
- Decided: Aug 20, 1997 after 51 days
- Product code: JSL (Culture Media, Anaerobic Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- 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 K854986 (1986). 2 ancestors in all.
6 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)
- K960997: Starswab Culture Collection and Transport System, Starplex Scientific, Inc. (1996) Summary page 1.
- K854986: BBL Port-a-Cul Aerobic Transport Sys, Modified Stu, Bd Becton Dickinson Vacutainer Systems Preanalytic (1986) Summary page 1.

## Most influential descendants
- K061301: Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System (2006), 4 descendants of its own
- 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
The Copan Venturi Transystem Amies Medium Without Charcoal products are sterile, single-use specimen collection chambers intended to preserve the viability of microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of clinical specimens for bacteriological examination. Copan Venturi Transystem Amies Medium Without Charcoal is designed to support the viability of a wide variety of clinically important aerobic and anaerobic bacteria.

Source page: https://510kreport.com/device/K972448
Methodology: https://510kreport.com/methodology