VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE

K991551 · Bd Becton Dickinson Vacutainer Systems Preanalytic · JKA · Sep 23, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991551
• Device Name: VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
• Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
• Product Code: JKA · Clinical Chemistry
• Decision Date: Sep 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The VACUTAINER® Brand Sodium Citrate Pediatric Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a tube containing Sodium Citrate anticoagulant is used primarily for clinical laboratory coagulation assays.

Device Story

VACUTAINER® Brand Sodium Citrate Pediatric Tube is a sterile, evacuated glass blood collection tube containing sodium citrate anticoagulant. Used in clinical laboratory settings by healthcare professionals to collect and transport whole blood. The tube facilitates the separation of plasma via centrifugation for subsequent analysis of coagulation parameters to detect clotting disorders or monitor anticoagulation therapy. The device functions as a closed system for specimen handling. The modification involves the rubber stopper material; clinical evaluations confirmed analytical and statistical equivalence to the predicate device.

Clinical Evidence

Clinical evaluations compared the modified VACUTAINER® Brand Sodium Citrate Pediatric Tube to the currently marketed predicate tube. Results demonstrated that the modified device is analytically and statistically equivalent to the predicate for coagulation assay performance.

Technological Characteristics

Sterile, evacuated glass blood collection tube; contains sodium citrate anticoagulant; features a modified rubber stopper. Operates as a closed system for blood collection and processing. No specific ASTM standards or software components mentioned.

Indications for Use

Indicated for collection, transport, and processing of blood samples for clinical laboratory coagulation assays in pediatric patients.

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 Sodium Citrate Tube (Pre-Amendment Device)

Submission Summary (Full Text)

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# I. 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

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### Establishment:

| • Address: | Becton Dickinson VACUTAINER Systems<br>1 Becton Drive<br>Franklin Lakes, NJ 07417-1885 |
|------------------------|------------------------------------------------------------------------------------------------------------|
| • Registration Number: | 2243072 |
| • Contact Person: | James W. Haynes<br>Regulatory Affairs Specialist<br>Telephone no.: 201) 847-5170<br>Fax No. [phone] |
| • Date of Summary: | February 2, 1999 |

Device =======================================================================================================================================================================

| Trade Name: | VACUTAINER® Brand Sodium Citrate<br>Pediatric 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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### Safety and Effectiveness Information Supporting the II. Substantial Equivalence Determination

Substantial Equivalence Declaration:

The term "Substantial Equivalence" as used in this 510(k) Premarket Notification is limited to the definition of Substantial E quivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR § 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of, substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

- . Device Description:
The VACUTAINER® Brand Sodium Citrate Pediatric Tubes are sterile, glass, evacuated blood collection tubes. The tube contains Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. The specimen is centrifuged and the plasma portion is analyzed for the coagulation parameters to detect clotting time disorders and/or monitor patients undergoing anticoagulation therapy.

Intended Use: .

> The VACUTAINER® Brand Sodium Citrate Pediatric Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a tube containing Sodium Citrate anticoagulant is used primarily for clinical laboratory coagulation assays.

Synopsis of Test Methods and Results .

Becton Dickinson VACUTAINER Systems has determined that the material modification of the rubber stopper to the VACUTAINER® Brand Sodium Citrate Pediatric Tube does not affect the performance or effectiveness of the device for its intended use. Clinical evaluations were performed to determine the affects of the modifications described herein.

The VACUTAINER® Brand Sodium Citrate Pediatric Tube was compared t the currently marketed VACUTAINER® Brand Sodium Citrate Tube. The modified VACUTAINER® Brand Sodium Citrate Pediatric Tube demonstrated analytically and statistically equivalent results.

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### Substantial Equivalence .

Based on comparison of the device features, materials, and intended use, the VACUTAINER® Brand Sodium Citrate Pediatric Tube can be shown to be substantially equivalent to the commercially available predicate device.

The predicate devices, K number, and clearance date are identified below:

| Manufacturer | Predicate Device | K-Number | Clearance Date |
|--------------------------------------------|---------------------------------------------|----------|-------------------------------------------------------------------------------------------------------------------------------|
| Becton Dickinson<br>VACUTAINER®<br>Systems | VACUTAINER®<br>Brand Sodium<br>Citrate Tube | N/A | Pre-Amendment Device<br>and, therefore, exempt<br>from premarket notification<br>requirements according to<br>the MDA of 1976 |

There are no new product claims described in this 510(k) Premarket Notification.

James W. Heyns

James W. Haynes Regulatory Affairs Specialist

February 2, 1999
Date

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 3 1999

Mr. James W. Haynes Regulatory Affairs Specialist Beckton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417-1885

- Re: K991551
Trade Name: VACUTAINER® Brand Sodium Citrate Pediatric Tube Regulatory Class: II Product Code: JKA Dated: August 23, 1999 Received: August 24, 1999

Dear Mr. Haynes:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrlvdsma/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): K991551

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The VACUTAINER® Brand Sodium Citrate Pediatric Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a tube containing Sodium Citrate anticoagulant is used primarily for clinical laboratory coagulation assays.

Gean Coogen

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991551

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Or

Over-the-Counter Use_

(Per 21 CFR § 801.109)

(Optional format 1-2-96)