BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774

K101502 · Becton, Dickinson & CO · JKA · Jun 29, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101502
• Device Name: BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774
• Applicant: Becton, Dickinson & CO
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jun 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The BD Vacutainer® Rapid Serum Tube Blood Collection Tube with Hemogard™ Closure (BD RST HG) is a single use tube used to collect, separate, transport and process venous blood specimens to obtain serum for chemistry determinations for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker. Clot time has not been established for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency. As a result, the use of BD RST HG in these patients is not recommended.

Device Story

BD Vacutainer® Rapid Serum Tube (RST HG) is a sterile, single-use, evacuated plastic blood collection tube with a Hemogard™ closure. Designed for rapid serum preparation; utilizes additives to accelerate blood clotting to 5 minutes, facilitating faster turnaround times for chemistry, serology, and immunology testing. Used in clinical settings by trained healthcare workers for venous blood collection. The device functions as a closed system for collection, transport, and separation of blood specimens. Healthcare providers use the resulting high-quality serum for diagnostic determinations. Benefits include reduced processing time compared to standard serum tubes.

Clinical Evidence

No clinical trials; performance established via bench testing and method comparison studies. Precision/reproducibility evaluated across 45 healthy subjects using variance components analysis (%CV/SD). Method comparison conducted at 4 clinical sites and internal facility using 55 analytes across various instrument platforms (Roche, Beckman Coulter, Siemens, Ortho, Biomerieux). Deming regression analysis showed high correlation (slopes 0.94-1.03) between candidate and predicate. Stability studies confirmed 12-month shelf life and 24-hour analyte stability at room temperature (with exceptions for LDL, triglycerides, and progesterone).

Technological Characteristics

Sterile, single-use, evacuated plastic blood collection tube; Hemogard™ closure; rubber stopper; additive-based clotting acceleration (5-minute clot time); closed system design.

Indications for Use

Indicated for venous blood collection, separation, transport, and processing to obtain serum for chemistry determinations in clinical settings by trained healthcare workers. Not recommended for patients on heparin therapy, direct thrombin inhibitor therapy, or with Factor I deficiency. Not recommended for amino acid determinations. Therapeutic drug monitoring, blood banking, and infectious disease performance not established, except for anti-CMV IgG and anti-CMV IgM.

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

• BD Vacutainer® SST™ Plus Blood Collection tube (BD SST™)

Submission Summary (Full Text)

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K101502

JUN 2 9 2010

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

### 1. 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:

- BD Diagnostics, Preanalytical Systems Address: . 1 Becton Drive, MC300 Franklin Lakes, NJ 07417 Registration Number: 1024879 .
- Mary Ann Alsberge Contact Person: . Regulatory Affairs Specialist BD Diagnostics, Preanalytical Systems Telephone No .: [phone] Fax No. [phone]
- June 25, 2010 Date of Summary: .

### Device

.

- BD Vacutainer® Rapid Serum Tube Blood Trade Name: . Collection Tube with Hemogard™ Closure
- JKA (Tubes, vials, systems, serum separators, Classification Name: blood collection)
- Class II Classification: .
- Performance Standards: None Established under 514 of the Food, Drug . and Cosmetic Act

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- Safety and Effectiveness Information Supporting the Substantial Equivalence Determination 2.
> Device Description:

BD Vacutainer® Tubes are sterile, single-use, evacuated plastic blood collection tubes with rubber stoppers that provide a means of collecting, transporting, separating, and processing blood in a closed tube. The BD Vacutainer® Rapid Serum Tube Blood Collection Tube with Hemogard™ Closure (BD RST HG) clots blood specimens much faster than other additives (5 minutes), and therefore is desirable when a fast turnaround-time is necessary.

#### > Intended Use:

The BD RST HG is a single use tube used to collect, separate, transport and process venous blood specimens to obtain serum for chemistry determinations for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker.

Clot time has not been established for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency. As a result, the use of BD RST HG in these patients is not recommended.

> Claims:

- BD RST HG tube clots blood in 5 minutes, providing high quality serum. .
- BD RST HG tube demonstrates substantially equivalent performance to the predicate . BD Vacutainer® SST™ Plus Blood Collection tube (BD SST™) for the collection, separation, transport, and processing of venous blood specimens for chemistry determinations requiring serum for in vitro diagnostic use.
- BD RST HG tube demonstrates substantially equivalent performance to the predicate . BD SST™ tube for the following selected serology analytes: anti-CMV IgG anti-CMV-IgM, and CRP.
- BD RST HG tube demonstrates substantially equivalent performance to the predicate . BD SST™ tube for the following selected immunology analytes: C3, C4, IgG IgM, and Rf .
- BD RST HG tube demonstrates substantially equivalent performance to the predicate . BD SST™ tube for 24 hr stability for analytes evaluated except LDL (16 hours), Progesterone (8 hours), and Triglycerides (15 hours).
- > Synopsis of Test Methods and Results

Clinical testing was performed on blood collected in both the evaluation and predicate tubes for a battery of routine and special chemistry analytes, and selected serology and immunology analytes. Clotting of blood within 5 minutes was demonstrated in the

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BD RST HG. The test results demonstrated that the evaluation device's performance was substantially equivalent to the legally marketed predicate device for tested analytes.

Based on a comparison of the device features, materials, and intended use, the BD RST HG is substantially equivalent to the commercially available predicate device, the BD SST™ tube.

May Ann Alaberge
Mary Ann Alaberge

Mary Ann Alsberge Regulatory Affairs Specialist BD Diagnostics, Preanalytical Systems

6/25/10
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 consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the eagle.

Public Health Service

Becton Dickinson & Co. c/o Ms. Mary Anne Alsberge Regulatory Affairs Specialist 1 Becton Drive, MC300 Franklin Lakes, NJ 07417-1885

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUN 2 9 2010

Re: k101502

Trade Name: BD Vacutainer® Rapid Serum Tube Blood Collection Tube with Hemogard™ Closure (BD RST HG) Regulation Number: 21 CFR §862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Codes: JKA Dated: May 28, 2010 Received: June 1, 2010

Dear Ms. Alsberge:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

CA

Courtney C. Harper, Ph.D. 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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# Indication for Use

510(k) Number (if known):k101502

Device Name: BD Vacutainer® Rapid Serum Tube Blood Collection Tube with Hemogard™ Closure

Indications for Use:

The BD Vacutainer® Rapid Serum Tube Blood Collection Tube with Hemogard™ Closure (BD RST HG) is a single use tube used to collect, separate, transport and process venous blood specimens to obtain serum for chemistry determinations for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker.

Clot time has not been established for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency. As a result, the use of BD RST HG in these patients is not recommended.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF 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

K101502 510(k)________________________________________________________________________________________________________________________________________________________________________

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