VACUETTE EVACUATED BLOOD COLLECTION TUBES

K011699 · Greiner Bio-One Vacuette North America · JKA · Jun 28, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011699
• Device Name: VACUETTE EVACUATED BLOOD COLLECTION TUBES
• Applicant: Greiner Bio-One Vacuette North America
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jun 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Greiner VACUETTE® blood collection tube with sodium heparin additive is an evacuated blood collection device that is used for the collection of venous blood. The VACUETTE® Tube is used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.

Device Story

VACUETTE® evacuated blood collection tube; plastic tube (13 x 75 mm) with plastic/rubber cap; includes vacuum tube holder for positioning. Used in clinical laboratories by healthcare professionals to collect venous blood samples. Sodium heparin additive acts as anticoagulant for plasma/whole blood testing. Device facilitates sample collection, transport, and processing for diagnostic analysis. Benefits include standardized blood collection and sample integrity for laboratory testing.

Clinical Evidence

Bench testing only. Comparative study performed on blood samples from 40 donors. Evaluated 27 common plasma analytes to compare performance of sodium heparin versus lithium heparin (predicate). Results showed equivalent performance.

Technological Characteristics

Evacuated blood collection tube; 13 x 75 mm dimensions; clear plastic tube; plastic and rubber cap; sodium heparin anticoagulant additive. Mechanical vacuum-based collection principle.

Indications for Use

Indicated for the collection, transport, and processing of venous blood for plasma or whole blood testing in clinical laboratory settings.

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

• Greiner VACUETTE® tube with lithium heparin (K960857)

Submission Summary (Full Text)

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K011699

Mav 31, 2001

# 510(K) SUMMARY

# Greiner VACUETTE® Evacuated Blood Collection Tubes with Sodium Heparin

Greiner VACUETTE® North America, Inc. P.O Box 1026 Monroe, NC 28111

For information regarding this 510(k) Summary, please contact Greiner VACUETTE® North America, Douglas L. Harris.

#### Device Names:

| Proprietary Name: | VACUETTE® Evacuated Blood Collection Tube with Sodium Heparin |
|----------------------|---------------------------------------------------------------|
| Common Name: | Blood Collection Tube with Sodium Heparin |
| Classification Name: | Tubes, Vials, Systems, Serum Separators, Blood Collection |

## Device Description:

VACUETTE® Tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. The VACUETTE® tube with sodium heparin may be used to collect a whole blood/plasma sample. The tube is composed of clear plastic. The cap is made of plastic and rubber. The tube size is 13 x 75 mm. The tube is equipped with a vacuum tube holder to assist in positioning the product when obtaining blood samples. The vacuum tube holder is composed of plastic.

#### Intended Use:

The Greiner VACUETTE® blood collection tube with sodium heparin additive is an evacuated blood collection device that is used for the collection of venous blood. The VACUETTE® Tube is used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.

### Substantial Equivalence:

The Greiner VACUETTE® tube with sodium heparin has been found to be substantially equivalent to the Greiner VACUETTE® tube with lithium heparin (K# 960857). Both blood collection tubes have the same intended use and contain the same tube material and stopper material. The tubes have different additives. The predicate device, Greiner VACUETTE® plasma tube with lithium heparin, contains lithium heparin as the anticoaqulant. The Greiner VACUETTE® plasma tube with sodium heparin contains sodium heparin as the anticoagulant.

A study was conducted on blood collected from 40 donors into each type of tube. Test results of 27 analytes commonly tested in plasma showed equivalent performance of the two anticoagulants.

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Greiner Bio-One Vacuette North America c/o Ms. Judith J. Smith Principal Suenna Partners, L.L.C. P.O. Box 103 Baldwin, MD 21013

JUN 2 8 2001

510(k) Number: K011699 Re: STO(K) Name: Vacuette® Blood Collection Tubes with Sodium Heparin Regulation Number: 862.1675 Regulatory Class: II Product Code: JKA Dated: May 31, 2001 Received: June 1, 2001

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becally be o(x) = is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device meetstate conmistoc prov to that have been reclassified in accordance with the provisions of the Alliendiffens, of to devices man have occast . You may, therefore, market the device, subject to Tecteral Food, Drug, and Ocentent Fee et. The general controls provisions of the Act include the general controls provincils of the Fring of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Fremarket Approval), it they of backed f Federal Regulations, Title 21, Parts 800 to 895. allecting your device can of rounning assumes compliance with the Good Manufacturing in A Substantally equiralene acterimeral (GMP) regulation (21 CFR Part 820) and that, through Practice for Mearcal bonn the Food and Drug Administration (FDA) will verify such penodic offir inspections, alle i oow alle GMP regulation may result in regulatory action. In assumptions: Transle to configer announcements concerning your device in the Federal addition, PDA may Puonen rainer annovour premarket notification submission does not affect Register. Flease note: this response to your proam proam 542 of the Act for devices under the ally obligation you might in Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothication. The FDA inding of successification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your do revices), please contact the Office of Compliance at additionally 607.10 for m Prito diagnestions on the promotion and advertising of your device, [phone]. Additionally, for question of [phone]. Also, please note the regulation prease conact the Office or Compilance (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small illionnation on your responsionnes are use are momber [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: VACUETTE® Blood Collection Tubes with sodium heparin

Indications For Use:

VACUETTE® tubes with sodium heparin are used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.

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Division of Clinical Laboratory Devices
510(k) Number

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)