GREINER VACUETTE BLOOD COLLECTION TUBE

K971221 · Greiner America, Inc. · GIM · May 2, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971221
• Device Name: GREINER VACUETTE BLOOD COLLECTION TUBE
• Applicant: Greiner America, Inc.
• Product Code: GIM · Clinical Chemistry
• Decision Date: May 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive and intended for use in evaluations of coagulation analyses.

Device Story

Evacuated blood collection tube containing sodium citrate anticoagulant; used for coagulation analysis. Device collects venous blood samples; facilitates transport and processing for clinical laboratory coagulation testing. Used in clinical settings by phlebotomists or healthcare personnel. Output is a stabilized blood sample for diagnostic evaluation. Benefits include standardized sample collection and preservation of coagulation parameters for accurate clinical decision-making.

Clinical Evidence

Bench testing only. Comparative study of paired blood samples collected in Greiner Vacuette® and Becton Dickinson Vacutainer® tubes. Evaluated 2 coagulation parameters; results showed good correlation between devices.

Technological Characteristics

Evacuated blood collection tube; clear plastic construction; sodium citrate anticoagulant additive; rubber stopper.

Indications for Use

Indicated for use in the collection of blood samples for coagulation analysis in patients requiring such testing.

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® sodium citrate tube

Submission Summary (Full Text)

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K971221
MAY - 2 1997

# 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 sodium citrate. The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive and intended for use in evaluations of coagulation analyses.

Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® sodium citrate tube. Both blood collection tubes have the same intended use and contain the same stopper material and additive. The tube material for the Greiner product is clear plastic, and the material for the Becton Dickinson product is glass. The equivalency of assay results of the two tubes was evaluated by testing paired samples collected in Greiner Vacuette® tubes and Becton Dickinson Vacutainer® tubes. Test results from paired samples for 2 coagulation parameters were evaluated and good correlation was observed.

Greiner's 510(k) has been submitted on April 1, 1997, by Ed Maier, Managing Director, Greiner America, Inc., P.O. Box 953279, Lake Mary, Florida 32795/3279 (407/333-2800).

W401A/81001.1