The BD Vacutainer® Rapid Serum Tube Plus Blood Collection Tube (BD RST) 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.

The BD RST is not recommended for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency.

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 Plus Blood Collection Tube (BD RST) clots blood specimens much faster than other additives (5 minutes), and therefore is desirable when a fast turn-around-time is necessary.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims "substantially equivalent performance" to the predicate device, the BD Vacutainer® SST™ Plus Blood Collection tube (BD SST™). This implies that the acceptance criteria for individual analytes were likely defined as meeting pre-determined equivalence bounds (e.g., within a certain percentage difference, or within clinical significance ranges). However, the specific quantitative acceptance criteria for each analyte are not explicitly stated in this document. The reported performance is that the device met these unstated equivalence criteria.

Claim/Acceptance Criteria	Reported Device Performance
Blood clotting time	Clots blood in 5 minutes
Substantially equivalent performance to predicate BD SST™ for routine and special chemistry analytes for collection, separation, transport, and processing of venous blood specimens to obtain serum	Demonstrated substantially equivalent performance to the predicate device for tested routine and special chemistry analytes.
Substantially equivalent performance to predicate BD SST™ for selected serology analytes (anti-CMV IgG, anti-CMV-IgM, CRP)	Demonstrated substantially equivalent performance to the predicate device for selected serology analytes.
Substantially equivalent performance to predicate BD SST™ for selected immunology analytes (C3, C4, IgG1 IgM, Rf)	Demonstrated substantially equivalent performance to the predicate device for selected immunology analytes.
24 hr stability for evaluated analytes	Demonstrated 24 hr stability for analytes evaluated except LDL (19 hours) and Triglycerides (6 hours).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "clinical testing was performed on blood collected in both the evaluation and predicate tubes" but does not give a specific number of samples or subjects.
Data Provenance: Not explicitly stated. There is no mention of the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable here. The study assesses the performance of a blood collection tube for clinical chemistry measurements, not the interpretation of medical images or diagnostic results that would typically require expert ground truth establishment. The ground truth for this type of test is the objective measurement of analytes by laboratory instrumentation.

4. Adjudication Method for the Test Set

This information is not applicable as the study design focuses on objective laboratory measurements rather than expert interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This is a study evaluating a blood collection device, not an AI-assisted diagnostic tool involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This information is not applicable. This is a study of a medical device (blood collection tube) with laboratory performance assessments, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used in this study would be the objective laboratory measurements/values of the various chemistry, serology, and immunology analytes obtained from the blood samples. This is determined by validated laboratory instruments and methodologies, not by expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

This information is not applicable. This study does not involve a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a machine learning algorithm in this study.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTI

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:

Address: .
Registration Number: .

Contact Person: .

BD Diagnostics, Preanalytical Systems 1 Becton Drive, MC300 Franklin Lakes, NJ 07417 1024879

291297

Mary Ann Alsberge Regulatory Affairs Specialist BD Diagnostics, Preanalytical Systems Telephone No .: (201) 847-3103 Fax No. (201) 847-4858

Date of Summary: .

Device

BD Vacutainer® Rapid Serum Tube Plus Trade Name: Blood Collection Tube
May 1, 2009
JKA (Tubes, vials, systems, serum separators, Classification Name: . blood collection)
Class II Classification: .
None Established under 514 of the Food, Drug Performance Standards: ● and Cosmetic Act

Safety and Effectiveness Information Supporting the Substantial Equivalence Determination 2.

Device Description:

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> Intended Use:

The BD RST is a single 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.

The BD RST is not recommended for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency.

> Claims:

BD RST tube clots blood in 5 minutes. .
BD RST 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 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 tube demonstrates substantially equivalent performance to the predicate . BD SST™ tube for the following selected immunology analytes: C3, C4, IgG1 IgM, and Rf.
BD RST tube demonstrates substantially equivalent performance to the predicate . BD SST™ tube for 24 hr stability for analytes evaluated except LDL (19 hours) and Triglycerides (6 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 BD RST. 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 is substantially equivalent to the commercially available predicate device, the BD SST™ tube.

Mary Ann Alsberge Regulatory Affairs Specialist BD Diagnostics, Preanalytical Systems Date

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Becton Dickinson & Company c/o Ms. Mary Ann Alsberge Regulatory Affairs Specialist 1 Becton Drive, MC 300 Franklin Lakes, NJ 07417

AUG 2 5 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Re: K091292

Trade Name: BD Vacutainer® Rapid Serum Tube Plus Blood Collection Tube Regulation Number: 21 CFR §862.1675 Regulation Name: Blood specimen collection devices. Regulatory Class: Class II Product Codes: JKA Dated: July 21, 2009 Received: July 22, 2009

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 (OS) regulation (21 CFR Part 820).

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Page 2

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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

G.C.H.

Courtney C. Harper, Ph.D. Acting 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):

K091292

Device Name: BD Vacutainer® Rapid Serum Tube Plus Blood Collection Tube

Indication For Use:

The BD RST is not recommended for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091292

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
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.(b)
Classification. Class II.