GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3

K960860 · Greiner America, Inc. · JKA · Sep 5, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960860
• Device Name: GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3
• Applicant: Greiner America, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Sep 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Greiner Vacuette™ blood collection tube with EDTA K₃ is an evacuated blood collection device containing EDTA K₃ anticoagulant additive and intended for use in evaluations of whole blood specimens.

Device Story

Evacuated blood collection tube; contains EDTA K₃ anticoagulant additive; used for whole blood specimen collection; facilitates hematology analysis; operated by clinical laboratory personnel; provides blood samples for diagnostic testing; enables accurate hematology parameter evaluation.

Clinical Evidence

Bench testing only. Comparative study of 15 hematology parameters using paired samples collected in Greiner Vacuette™ and Becton Dickinson Vacutainer® tubes; results showed good correlation.

Technological Characteristics

Evacuated blood collection tube; clear plastic construction; contains EDTA K₃ anticoagulant additive; compatible with standard hematology analysis workflows.

Indications for Use

Indicated for use in the collection and storage of whole blood specimens for hematology evaluations.

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 EDTA K₃ additive tube (K940905)

Submission Summary (Full Text)

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K960860

SEP 5 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 EDTA K₃. The Greiner Vacuette™ blood collection tube with EDTA K₃ is an evacuated blood collection device containing EDTA K₃ anticoagulant additive and intended for use in evaluations of whole blood specimens.

Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® brand EDTA K₃ additive tube (K940905). 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 15 hematology parameters were evaluated and good correlation was observed.

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).

01/239174.1