BD VACUTAINER PLUS PST II TUBE

K022130 · Becton, Dickinson & CO · JKA · Jul 29, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022130
• Device Name: BD VACUTAINER PLUS PST II TUBE
• Applicant: Becton, Dickinson & CO
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jul 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The BD Vacutainer™ PLUS PST II™ Tube is a lithium heparin coated plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS PST II™ Tube is used for clinical laboratory assays involving the use of patient plasma.

Device Story

Sterile, plastic, evacuated blood collection tube; contains closure assembly, inert acrylic gel mechanical barrier, and lithium heparin coating. Used in clinical laboratories for blood collection/processing. Centrifugation causes gel barrier to form at plasma interface, mechanically separating plasma from cells. Plastic construction reduces breakage risk and improves personnel safety. Provides improved plasma quality and analyte stability (up to 24 hours post-centrifugation; 2 hours for cardiac analytes: troponin I, CKMB, myoglobin) compared to previous generation tubes. Facilitates clinical decision-making by providing stable plasma samples for laboratory assays.

Clinical Evidence

Clinical evaluations compared the subject device to the predicate BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube. Results demonstrated clinically equivalent chemistry analyte results between the two tubes.

Technological Characteristics

Sterile, plastic, evacuated blood collection tube. Components: closure assembly, inert acrylic gel mechanical barrier, lithium heparin coating. Mechanical separation principle via centrifugation. No electronic or software components.

Indications for Use

Indicated for use in clinical laboratory settings for the collection, transport, and processing of blood samples to obtain patient plasma for diagnostic assays.

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

• VACUTAINER™ Brand PST™ PLUS Tube (K945952)

Submission Summary (Full Text)

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# JUL 2 9 2002

# J. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## 510(k) Summary Of Safety and Effectiveness

## I. General Information

This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92

#### Establishment:

| • Address: | BD VACUTAINER Systems, Preanalytical Solutions<br>1 Becton Drive, MC 300<br>Franklin Lakes, NJ 07417-1885 |
|------------------------|-----------------------------------------------------------------------------------------------------------|
| • Registration Number: | 2243072 |
| • Contact Person: | Jing Zhang<br>Manager Regulatory Affairs<br>Telephone No.:[phone]<br>Fax No. [phone] |
| • Date of Summary: | July 24, 2002 |

#### Device

.

- Trade Name: BD Vacutainer™ PLUS PST II™ Tube
- Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
- Classification: Class II .
- None Established under 514 of the Food, Performance Standards: . Drug and Cosmetic Act

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- Safety and Effectiveness Information Supporting the Substantial Equivalence II. Determination
#### > Device Description:

The Vacutainer™ PLUS PST II™ Tubes are sterile, plastic, evacuated blood collection tubes. The Vacutainer™ PLUS PST II™ Tube consists of: (1) a closure assembly. (2) an inert acrylic gel mechanical barrier, and (3) a lithium heparin coated plastic tube. The specimen is centrifuged and the barrier material forms at the plasma interface, mechanically separating the plasma from cells. The plasma portion is used for clinical laboratory assays involving the use of patient plasma. The benefits of a plastic tube decrease the occurrence of accidental breakage increases the safety of laboratory personnel and reduces the necessity of repeat specimens.

#### > Intended Use:

The BD Vacutainer™ PLUS PST II™ Tube is a lithium heparin coated plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS PST II™ Tube is used for clinical laboratory assays involving the use of patient plasma.

- > Claims:
The PLUS PST II™ Tube: (1) provides improved plasma quality vs. the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube: (2) provides selected analyte stability up to twenty-four hours after centrifugation; and (3) provides stability for up to two hours after centrifugation for the following cardiac analytes: troponin I, creatine kinase MB fraction (CKMB), and myoglobin.

#### > Synopsis of Test Methods and Results

Clinical evaluations were performed to determine the safety and efficacy of the BD Vacutainer™ PLUS PST II™ Tube. The BD Vacutainer™ PLUS PST II™ Tube was compared to the currently marketed BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube. The results of the clinical evaluation demonstrated that the BD Vacutainer™ PLUS PST II™ Tube provides clinically equivalent chemistry analyte results when compared to the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube.

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## > Substantial Equivalence

Based on a comparison of the device features, materials, and intended use, the BD Vacutainer™ PLUS PST II™ Tube are substantially equivalent to the commercially available predicate device. The only difference between the predicate Vacutainer™ PLUS PST™ Tubes and the Vacutainer™ PLUS PST IITM Tubes is the acrylic gel material. The predicate device, K number, and clearance date are identified below:

| Manufacturer | Predicate Device | K-Number | Clearance Date |
|------------------------|----------------------------------|----------|----------------|
| BD VACUTAINER™ Systems | VACUTAINER™ Brand PST™ PLUS Tube | K945952 | 1/18/95 |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUL 2 9 2002

Mr. Jing Zhang Manager, Regulatory Affairs Becton, Dickinson and Company 1 Becton Drive, MC 300 Franklin Lakes, NJ 07417-1885

Re: k022130

> Trade/Device Name: BD Vacutainer136 Plus PST IITM Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: June 28, 2002 Received: July 1, 2002

Dear Mr. Zhang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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 predicate device results in a classification 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 ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact.the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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# B. INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Koz2130

Device Name: BD Vacutainer™ PLUS PST II™ Tube

Indications for Use:

The BD Vacutainer™ PLUS PST II™ Tube is a lithium heparin coated plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS PST II™ Tube is used for clinical laboratory assays involving the use of patient plasma.

(Please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE) ﻟﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ Prescription Use Or Over-the-Counter Use (Optional format 1-2-96) (Per 21 CFR § 801.109)

Hean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KO 22130