# K971239: Greiner Vacuette Blood Collection Tube

- Pathway: 510(k) (Traditional)
- Applicant: Greiner America, Inc.
- Decided: May 12, 1997 after 40 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 2 (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 its predicate without a number.
- (no number) Becton Dickinson's Vacutainer® tube with sodium EDTA/sodium fluoride: named in the summary without a submission number
- (no number) Becton Dickinson’s Vacutainer® tube with sodium fluoride and potassium oxalate: named in the summary without a submission number

## Recalls of this device
- Dec 12, 2023 · Class II · Z-0733-2024: Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosi
- Apr 26, 2016 · Class II · Z-1923-2016: The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.

## Indications for use
Both Greiner Vacuette® blood collection tubes are evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.

Source page: https://510kreport.com/device/K971239
Methodology: https://510kreport.com/methodology