Who is the manufacturer of GREINER VACUETTE BLOOD COLLECTION TUBE?

Greiner America, Inc. submitted the Traditional clearance for GREINER VACUETTE BLOOD COLLECTION TUBE (K971239).

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's Vacutainer® tube with sodium EDTA/sodium fluoride; Becton Dickinson's Vacutainer® tube with sodium fluoride and potassium oxalate.

GREINER VACUETTE BLOOD COLLECTION TUBE

K971239 · Greiner America, Inc. · JKA · May 12, 1997 · Clinical Chemistry

Device Facts

Record ID	K971239
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

Greiner Vacuette® blood collection tube with EDTA and sodium fluoride; and (2) its Greiner Vacuette® blood collection tube with potassium oxalate and sodium fluoride. Both Greiner Vacuette® blood collection tubes are evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.

Device Story

Evacuated blood collection tubes; used for glucose and lactate testing. Input: venous blood sample. Operation: vacuum-based collection; additives (EDTA/sodium fluoride or potassium oxalate/sodium fluoride) stabilize blood for laboratory analysis. Output: blood sample contained in tube for clinical laboratory processing. Used in clinical settings by phlebotomists or healthcare personnel. Benefit: standardized sample collection for accurate diagnostic testing.

Clinical Evidence

Bench testing only. Comparative study of paired samples collected in Greiner Vacuette tubes versus Becton Dickinson Vacutainer tubes. Glucose assay results evaluated for correlation; good correlation observed.

Technological Characteristics

Evacuated blood collection tubes; clear plastic construction; additives include EDTA, sodium fluoride, and potassium oxalate. Stopper material identical to predicate. Non-electronic; no software.

Indications for Use

Indicated for use in the collection of blood samples for the testing of glucose and lactate levels in patients requiring such diagnostic 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's Vacutainer® tube with sodium EDTA/sodium fluoride
Becton Dickinson's Vacutainer® tube with sodium fluoride and potassium oxalate

Related Devices

K231237 — BD Vacutainer® Fluoride Blood Collection Tubes · Becton, Dickinson and Company · Jan 19, 2024
K971236 — GREINER VACUETTE BLOOD COLLECTION TUBE · Greiner America, Inc. · May 12, 1997
K971111 — TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER · Tri-Tech, Inc. · Jun 16, 1997
K093910 — IMPROVACUTER GEL & CLOT ACTIVATOR TUBE · Guangzhou Improve Medical Instruments Co., Ltd. · Jul 12, 2010

Submission Summary (Full Text)

{0} K971239 # I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS MAY 12 1997 Greiner America, Inc. ("Greiner") is submitting a 510(k) premarket notification for: (1) its Greiner Vacuette® blood collection tube with EDTA and sodium fluoride; and (2) its Greiner Vacuette® blood collection tube with potassium oxalate and sodium fluoride. Both Greiner Vacuette® blood collection tubes are evacuated blood collection devices intended for use in testing glucose and lactate levels in blood. For the above two tubes, Greiner is claiming substantial equivalence to, respectively: (1) Becton Dickinson's Vacutainer® tube with sodium EDTA/sodium fluoride; and (2) Becton Dickinson's Vacutainer® tube with sodium fluoride and potassium oxalate. Both the Greiner and Becton Dickinson blood collection tubes have the same intended use and contain the same stopper material and additives. 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® EDTA/sodium fluoride tubes and Becton Dickinson Vacutainer® sodium EDTA and sodium fluoride tubes, and paired samples collected in Greiner Vacuette® potassium oxalate and sodium fluoride tubes and Becton Dickinson potassium oxalate and sodium fluoride tubes. Glucose assay results from paired samples for each tube type 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). VA01A/76553.1