BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381

K041071 · Becton, Dickinson & CO · JKA · May 14, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041071
• Device Name: BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381
• Applicant: Becton, Dickinson & CO
• Product Code: JKA · Clinical Chemistry
• Decision Date: May 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube is used for trace element testing (e.g., Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc).

Device Story

Plastic evacuated blood collection tubes (13x100, 6ml) with Royal blue Hemogard™ closures; contain silica clot activator or K2EDTA additive. Used for collection, transport, and processing of blood samples in a closed system. Facilitates trace element testing (e.g., Arsenic, Lead, Mercury). Used in clinical settings by healthcare professionals. Provides a stable environment for blood samples prior to laboratory analysis; ensures sample integrity for trace element quantification.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance criteria met following material and additive modifications.

Technological Characteristics

Plastic evacuated blood collection tubes (13x100, 6ml); Royal blue Hemogard™ closure; Additives: Silica clot activator or K2EDTA. Closed system design.

Indications for Use

Indicated for use in patients requiring blood collection for trace element testing, including Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc.

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.

Submission Summary (Full Text)

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KO41071

# Attachment 4

MAY 1 4 2004

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 CFR § 807.92

#### Establishment:

- Address: .
- Registration Number: .

Contact Person: .

- BD Diagnostics, Preanalytical Systems 1 Becton Drive Franklin Lakes, NJ 07417-1885 2243072 Jing Zhang Regulatory Affairs Manager Telephone no .: 201-847-4717 Fax No. 201-847-4858 4/23/04
- Date of Summary: .

Device:

- Trade Name: .
- Classification Name: .
- Classification: .
- Performance Standards: .

BD Vacutainer® Trace Element Serum Plus Tube BD Vacutainer® Trace Element K2EDTA Plus Tube

Evacuated Blood Collection Tube Class II

None Established under 514 of the Food, Drug and Cosmetic Act

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# CONFIDENTIAL

## II Effectiveness Information Supporting Substantial Equivalence

- Device Description �
The device description of the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are as follows:

- Plastic tube (13x100, 6ml)

- Tube closure: Royal blue Hemogard™ closure
- Additive: Silica Clot Activator or K2EDTA
- Intended Use .

The BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube is used for trace element testing (e.g., Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc).

- Synopsis of Performance Study Results .
Extensive mechanical and functional testing was performed to demonstrate the devices' safety and effectiveness.

### III. Predicate Device Summary Table

Based on comparison of the device features, materials, intended use and performance, the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are shown to be substantially equivalent to the commercially available predicate devices indicated in the table below.

| Manufacturer | Predicate Device | 510(k) Number |
|----------------------------------|----------------------------------------------------|---------------|
| Becton, Dickinson and<br>Company | BD Vacutainer® Trace Element Serum Glass<br>Tube | Preamendment |
| | BD Vacutainer® Trace Element Na2EDTA<br>Glass Tube | |

Jie 52

Date

4/22/14

Pages of 2.

Jing Zhang Requlatory Affairs Manager BD Diagnostics, Preanalytical Systems Becton, Dickinson and Company

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 4 2004

Ms. Jing Zhang Regulatory Affairs Manager Becton Dickinson & Co. BD Diagnostics, PreAnalytical System 1 Becton Drive Franklin Lakes, NJ 07417

k041071 Re:

Trade/Device Name: The BD Vacutainer®Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: April 23, 2004 Received: April 26, 2004

Dear Ms. 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 cither 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) I mo lotter notification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, Ir you stions 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). You may obtain other general information on your responsibilities under the Act 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,

Jean M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K040171

DEvICE NAME: The BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube

INDICATIONS FOR USE:

The BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube is used for trace element testing (e.g., Arsenic Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, adduni,

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD4/0671

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