Who is the manufacturer of GREINER VACUETTE BLOOD COLLECTION TUBE?

Greiner America, Inc. filed the 510(k) submission for GREINER VACUETTE BLOOD COLLECTION TUBE (K971236).

What is the FDA product code for GREINER VACUETTE BLOOD COLLECTION TUBE?

JKA. It is classified under 21 CFR 862.1675 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for GREINER VACUETTE BLOOD COLLECTION TUBE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GREINER VACUETTE BLOOD COLLECTION TUBE?

Becton Dickinson Vacutainer® brand EDTA K₂ additive tube.

Who can help prepare an FDA 510(k) submission like GREINER VACUETTE BLOOD COLLECTION TUBE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GREINER VACUETTE BLOOD COLLECTION TUBE

K971236 · Greiner America, Inc. · JKA · May 12, 1997 · Clinical Chemistry

Device Facts

Record ID	K971236
Device Name	GREINER VACUETTE BLOOD COLLECTION TUBE
Applicant	Greiner America, Inc.
Product Code	JKA · Clinical Chemistry
Decision Date	May 12, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1675
Device Class	Class 2

Intended Use

The Greiner Vacuette® blood collection tube with EDTA K₂ is an evacuated blood collection device containing EDTA K₂ anticoagulant additive and intended for use in evaluations of whole blood specimens.

Device Story

Evacuated blood collection tube containing EDTA K₂ anticoagulant; used for whole blood specimen collection and storage. Device consists of clear plastic tube with stopper; replaces traditional glass tubes. Used in clinical laboratory settings by phlebotomists or healthcare personnel. Input: venous blood sample. Output: stabilized whole blood specimen for hematology analysis. Clinical benefit: provides reliable sample collection 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® tubes and Becton Dickinson Vacutainer® tubes. Results showed good correlation between the two systems.

Technological Characteristics

Evacuated blood collection tube; clear plastic construction; contains EDTA K₂ anticoagulant additive; stopper material identical to predicate.

Indications for Use

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

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 K₂ additive tube

Related Devices

K960860 — GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 · Greiner America, Inc. · Sep 5, 1996
K213670 — BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes · Becton, Dickinson and Company · Aug 25, 2023
K981013 — VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE · Becton Dickinson Vacutainer Systems · Jun 17, 1998
K971221 — GREINER VACUETTE BLOOD COLLECTION TUBE · Greiner America, Inc. · May 2, 1997

Submission Summary (Full Text)

{0} K971236 MAY 12 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 EDTA K₂. The Greiner Vacuette® blood collection tube with EDTA K₂ is an evacuated blood collection device containing EDTA K₂ anticoagulant additive and intended for use in evaluations of whole blood specimens. Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® brand EDTA K₂ additive 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 15 hematology 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 (407/3332800). MA01A/82707.1