# K991120: Vacutainer Brand Ctad Tube (Multiple)

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vacutainer Systems
- Decided: May 19, 1999 after 47 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
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 its predicate without a number.
- (no number) VACUTAINER® Brand Sodium Citrate Tube: named in the summary without a submission number

## Indications for use
The VACUTAINER® Brand CTAD Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. The CTAD additive, a combination of a buffered sodium Citrate, theophylline, adenosine and dipyridamole, provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.

Source page: https://510kreport.com/device/K991120
Methodology: https://510kreport.com/methodology