BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE

K023075 · Bd Vacutainer Systems Preanalyical Solutions · JKA · Nov 25, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023075
• Device Name: BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
• Applicant: Bd Vacutainer Systems Preanalyical Solutions
• Product Code: JKA · Clinical Chemistry
• Decision Date: Nov 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Vacutainer™ PLUS SST™ Tube is a plastic evacuated blood collection tube with silica clot activator and gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS SST™ Tube is primarily used for clinical laboratory testing in chemistry using patient serum, but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the Vacutainer™ PLUS SST™ Tube is compatible with many commonly used therapeutic drugs therefore suitable for therapeutic drug monitoring (TDM). Blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery.

Device Story

Sterile, plastic, evacuated blood collection tube; contains closure assembly, inert polyester gel barrier, silica clot activator, and silicone surfactant coating. Used in clinical laboratory settings for blood collection and processing. Centrifugation causes gel barrier to form at serum/blood clot interface, mechanically separating serum from cells. Enables collection, transport, and storage of blood for at least 24 hours for therapeutic drug monitoring (TDM) without significant recovery loss. Supports clinical decision-making by maintaining specimen integrity for TDM and chemistry assays.

Clinical Evidence

Clinical evaluation performed to validate the 24-hour stability claim for therapeutic drug monitoring (TDM). Results demonstrated that blood collected, processed, and stored in the tube for at least 24 hours maintains specimen integrity without large losses in recovery for TDM assays.

Technological Characteristics

Plastic evacuated tube; components include closure assembly, inert polyester gel barrier, silica clot activator, and silicone surfactant coating. Mechanical separation principle via centrifugation. Non-powered, standalone device.

Indications for Use

Indicated for the collection, transport, separation, and processing of blood for clinical laboratory testing, specifically chemistry assays and therapeutic drug monitoring (TDM) using patient serum.

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™ PLUS SST™ Serum Separator Tube (K960250)

Submission Summary (Full Text)

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16023075

# NOV 2 5 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<br>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: | Nov. 21, 2002 |
| | Device | |
| • | Trade Name: | BD Vacutainer™ PLUS SST™ Tube |
| • | Classification Name: | Tubes, Vials, Systems, Serum Separators<br>Blood Collection |
| • | Classification: | Class II |
| • | Performance Standards: | None Established under 514 of the Food,<br>Drug and Cosmetic Act |

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

The Vacutainer™ PLUS SST™ Tubes are sterile, plastic, evacuated blood collection tubes. The Vacutainer™ PLUS SST™ Tube consists of: (1) a closure assembly, (2) an inert polyester gel barrier, (3) silica clot activator, and (4) a silicone surfactant coated plastic tube. The specimen is centrifuged and the barrier material forms at the serum/blood clot interface, mechanically separating the serum from cells. The serum portion is used for clinical laboratory assays involving the use of patient serum.

#### > Intended Use:

The Vacutainer™ PLUS SST™ Tube is a plastic evacuated blood collection tube with silica clot activator and gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS SST™ Tube is primarily used for clinical laboratory testing in chemistry using patient serum, but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the Vacutainer™ PLUS SST™ Tube is compatible with many commonly used therapeutic drugs therefore suitable for therapeutic drug monitoring (TDM). Blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery.

### > Claims:

Blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery. The storage conditions and time until analysis should be considered when collecting blood in Vacutainer™ PLUS SST™ tubes for TDM. This will ensure specimen integrity is maintained.

#### Synopsis of Test Methods and Results: A

Clinical evaluations were performed to determine the safety and efficacy of the Vacutainer™ PLUS SST™ Tube. The results of the clinical evaluation demonstrated that blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery. The storage conditions and time until analysis should be considered when collecting blood in Vacutainer™ PLUS SST™ tubes for TDM. This will ensure specimen integrity is maintained.

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- > Substantial Equivalence:
Based on a comparison of the device features, materials, and intended use, the Vacutainer™ PLUS SST™ Tubes are substantially equivalent to the commercially available predicate device. The only difference between the predicate and the Vacutainer™ PLUS SSTTM Tubes is the performance claim for therapeutic drug monitoring (TDM). The predicate device, K number, and clearance date are identified below:

| Manufacturer | Predicate Device | K-Number | Clearance Date |
|---------------------------------------------------|-------------------------------------------------------|----------|----------------|
| BD Vacutainer Systems,<br>Preanalytical Solutions | VacutainerTM<br>PLUS SSTTM<br>Serum Separator<br>Tube | K960250 | March 29, 1996 |

3M

Jing Zhang Manager Regulatory Affairs

11/21/02

Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Mr. Jing Zhang Manager, Regulatory Affairs · · BD Vacutainer Systems, Preanalytical Solutions 1 Becton Drive, MCC 300 Franklin Lakes, NJ 07417

Re: k023075

Trade/Device Name: BD Vacutainer™ PLUS SSTTM Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: August 29, 2002 Received: September 16, 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour 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 Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 deviceto proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## B. INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: BD Vacutainer™ PLUS SST™ Tube

Indications for Use:

The Vacutainer™ PLUS SST™ Tube is a plastic evacuated blood collection tube with silica clot activator and gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS SST™ Tube is primarily used for clinical laboratory testing in chemistry using patient serum, but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the Vacutainer™ PLUS SST™ Tube is compatible with many commonly used therapeutic drugs therefore suitable for therapeutic drug monitoring (TDM). Blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR § 801.109)

(Optional format 1-2-96)

Or Over-the-Counter Use***_***

Sean Cooper
(Division Sign-Off)

Division of Clinical Labora. Jvices
510(k) Number K023075