GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR

K960858 · Greiner America, Inc. · JKA · Aug 30, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960858
• Device Name: GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & 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 product is intended for use in holding and separating blood serum from the cellular components of blood.

Device Story

Evacuated blood collection tube; contains silicon dioxide clot activator and inert polymeric gel separator; used to collect venous blood; centrifugation causes gel to form physical barrier between serum and cellular components; enables serum isolation for laboratory analysis; used by phlebotomists and clinical laboratory personnel; facilitates diagnostic testing by providing stable serum samples.

Clinical Evidence

Bench testing only. Comparative study of 41 analytes using paired samples collected in Greiner Vacuette™ and Becton Dickinson Vacutainer® tubes. Results demonstrated good correlation with coefficients ranging from 0.864 to 1.000.

Technological Characteristics

Evacuated blood collection tube; clear plastic tube body; silicon dioxide clot activator; inert polymeric gel separator; stopper material consistent with predicate.

Indications for Use

Indicated for use in clinical settings for the collection of blood samples and the subsequent separation of serum from cellular components.

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® SST tubes (K921806)

Submission Summary (Full Text)

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K960858
AUG 30 1996

# I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Greiner America, Inc. ("Greiner") is submitting a 510(k) premarket notification for its Greiner Vacuette™ blood collection tube with clot activator and gel separator. The Greiner Vacuette™ blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator (silicondioxide) and an inert polymeric barrier material. The product is intended for use in holding and separating blood serum from the cellular components of blood.

Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® SST tubes (K921806). Both blood collection tubes have the same intended use and contain the same stopper material, clot activator and separator. The tube material for the Greiner product is clear plastic, whereas the material for the Becton Dickinson product is glass. The equivalency of assay results for both tubes was evaluated by testing paired samples collected in Greiner Vacuette™ tubes and Becton Dickinson Vacutainer® tubes. Test results from paired samples for 41 analytes were evaluated demonstrating good correlation (correlation coefficients ranging from .864 to 1.000).

Greiner's 510(k) has been submitted on February 27, 1996, by Ed Maier, Managing Director, Greiner America, Inc., 7 Henry Court, Wilmington, Delaware, 19808 (302/998-8046).

VA01/238976.1