# K012152: DS30 Hcy Blood Collection Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Drew Scientific, Ltd.
- Decided: Sep 18, 2001 after 69 days
- Product code: GIM (Tubes, Vacuum Sample, With Anticoagulant)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3-deazaadenosine (enzyme inhibitor) for the collection and stabilization of 2.5 mL whole blood prior to removal of plasma for total homocysteine measurement by HPLC for the detection of hyperhomocysteinemia.

Source page: https://510kreport.com/device/K012152
Methodology: https://510kreport.com/methodology