GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR
Device Facts
| Record ID | K960857 |
|---|---|
| Device Name | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR |
| Applicant | Greiner America, Inc. |
| Product Code | JKA · Clinical Chemistry |
| Decision Date | Aug 30, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
Intended Use
The Greiner Vacuette™ blood collection tube with anticoagulant lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.
Device Story
Evacuated blood collection tube; contains lithium heparin anticoagulant and inert polymeric gel separator; used for plasma separation from cellular blood components. Operated by clinical laboratory personnel; blood sample drawn into tube via vacuum; centrifugation separates plasma from cells. Healthcare providers use separated plasma for clinical chemistry analysis. Benefits include standardized sample collection and efficient plasma isolation for diagnostic testing.
Clinical Evidence
Bench testing only. Comparative study of paired samples collected in Greiner Vacuette™ and Becton Dickinson Vacutainer® tubes. Evaluated 23 analytes and 3 hormones. Results showed good correlation with coefficients ranging from 0.168 to 0.999.
Technological Characteristics
Evacuated blood collection tube; clear plastic construction; contains lithium heparin anticoagulant and inert polymeric barrier gel. Standalone device.
Indications for Use
Indicated for the collection, holding, and separation of blood plasma from cellular components in clinical laboratory settings.
Regulatory Classification
Identification
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
Predicate Devices
- Becton Dickinson Vacutainer® brand lithium heparin additive tube (K944566)
Related Devices
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- K022130 — BD VACUTAINER PLUS PST II TUBE · Becton, Dickinson & CO · Jul 29, 2002
- K103041 — VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR · Greiner Bio-One North America, Inc. · Nov 9, 2010
- K160657 — BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube · Becton, Dickinson and Company · Sep 23, 2016
