# K060364: Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation Tube

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Jun 15, 2006 after 122 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- 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 K960250 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023075: BD Vacutainer Plus SST Serum Separator Tube, Bd Vacutainer Systems Preanalyical Solutions (2002) Summary page 2.

## Indications for use
1. The Vacu Lab Plain Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use patient serum. 2. The Vacu Lab Gel & Clot Activator Tube is a sterile, plastic, evacuated of blood collection tube with a silica clot activator and a barrier gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use of patient serum.

Source page: https://510kreport.com/device/K060364
Methodology: https://510kreport.com/methodology