# K983952: Greiner Vacuette Blood Collection Tube

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Meditech, Inc.
- Decided: Dec 28, 1998 after 53 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
Longest line of descent: 2 generations back to K921806 (1992). 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)
- K960858: Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator, Greiner America, Inc. (1996) Summary page 1.
- (no number) Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes: named in the summary without a submission 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
- Nov 25, 2019 · Class II · Z-0818-2020: The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.

## Indications for use
To collect, transport, store and process blood for testing serum in the clinical laboratory. In addition, tubes are suitable for therapeutic drug monitoring.

Source page: https://510kreport.com/device/K983952
Methodology: https://510kreport.com/methodology