# K081929: Vacuette Blood Collection Tube with Clot Activator and Gel Separator

- Pathway: 510(k) (Special)
- Applicant: Greiner Bio-One North America, Inc.
- Decided: Dec 16, 2008 after 162 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Aug 19, 2025 · Class II · Z-0571-2026: Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recoll
- May 14, 2024 · Class II · Z-2375-2024: The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample reco
- Aug 28, 2020 · Class II · Z-3027-2020: Blood collection tubes experienced an issue with separation and clotting

## Indications for use
VACUETTE® Blood Collection Tubes with Clot Activator, Gel Separator, and Standard Stopper (16 x 100 mm, 8 mL) are used to collect, transport and process blood for testing serum in the clinical laboratory. In addition, the tubes are suitable for therapeutic drug monitoring (TDM).

Source page: https://510kreport.com/device/K081929
Methodology: https://510kreport.com/methodology