# K960997: Starswab Culture Collection and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Starplex Scientific, Inc.
- Decided: Apr 3, 1996 after 22 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
No predicates in its family tree.
8 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)
- None. The FDA summary names its predicate without a number.
- (no number) Amies CultureSwab™ Transport Systems with and without charcoal: named in the summary without a submission number

## Most influential descendants
- K972448: Copan Venturi Transystem Amies Medium Without Charcoal (1997), 6 descendants of its own
- 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

## Indications for use
The Starswab Culture Collection and Transport System is self-contained, sterile and intended for maintaining the viability of clinical specimens during transportation to the laboratory.

Source page: https://510kreport.com/device/K960997
Methodology: https://510kreport.com/methodology