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 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.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called the "BD Vacutainer® Rapid Serum Tube Blood Collection Tube with Hemogard™ Closure (BD RST HG)". This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining explicit acceptance criteria and presenting a detailed study report. Therefore, some of the requested information (like specific numerical acceptance criteria or detailed study methodologies) is not explicitly stated.

However, I can extract the available information to address your points as much as possible.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" appear to be the demonstration of "substantial equivalence" to the predicate device, the BD Vacutainer® SST™ Plus Blood Collection tube (BD SST™), across several performance aspects.

Acceptance Criteria (Implied)	Reported Device Performance
Clot blood specimens within 5 minutes.	Met: "Clotting of blood within 5 minutes was demonstrated in the BD RST HG."
Substantially equivalent performance to predicate BD SST™ for collection, separation, transport, and processing of venous blood specimens for chemistry determinations.	Met: "The test results demonstrated that the evaluation device's performance was substantially equivalent to the legally marketed predicate device for tested analytes." (This is a general statement; specific metrics are not provided in this summary).
Substantially equivalent performance to predicate BD SST™ for selected serology analytes (anti-CMV IgG, anti-CMV-IgM, CRP).	Met: "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." (Specific equivalence metrics/P-values are not provided).
Substantially equivalent performance to predicate BD SST™ for selected immunology analytes (C3, C4, IgG IgM, Rf).	Met: "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." (Specific equivalence metrics/P-values are not provided).
Substantially equivalent performance to predicate BD SST™ for 24-hour stability for evaluated analytes.	Met (with exceptions): "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)." (This indicates equivalence for most, but not all, analytes for 24 hours, with specific shorter stability times noted for LDL, Progesterone, and Triglycerides. The document doesn't provide specific criteria for "substantially equivalent" in this context).

Additional Requested Information:

Since this is a 510(k) Summary, much of the granular detail about the study methodology (like sample sizes, expert qualifications, etc.) is not present. This document provides a high-level overview to satisfy the regulatory requirements for substantial equivalence.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The document states "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." This implies a set of human blood samples were used, but the quantity is not given.
- Data Provenance: Not specified. There is no information about the country of origin of the data, nor whether it was retrospective or prospective. Given it's "clinical testing," it was likely prospective collection for the purpose of the study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is largely irrelevant for this type of device. Blood collection tubes are evaluated based on their ability to preserve analytes and facilitate accurate lab test results, not on expert interpretation of images or clinical reports. The "ground truth" here would be the actual concentration of analytes in the blood as measured by standardized laboratory methods, usually comparing samples from the test device to samples from the predicate device (or sometimes a gold standard collection method, though not explicitly stated here). There is no mention of human "experts" establishing a ground truth in the sense of a diagnostic interpretation.
Adjudication method for the test set:
- Not applicable/Not specified. As explained above, this isn't a device that relies on human interpretation or adjudication in the typical sense (e.g., for image reading). The "adjudication" is done by laboratory equipment measuring analyte concentrations.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a blood collection tube, not an AI-powered diagnostic or imaging system that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm. Its performance is chemical, mechanical, and biological; it's about the physical collection and preservation of blood.
The type of ground truth used:
- The "ground truth" in this context is the accurate measurement of analyte concentrations in blood serum, typically achieved through standard laboratory assays (e.g., spectrophotometry, immunoassays) using clinically validated instruments. The performance of the BD RST HG is compared to the predicate device (BD SST™) to demonstrate that it yields comparable and accurate results for these measurements.
The sample size for the training set:
- Not applicable. This document describes a clinical validation study for a physical medical device (blood collection tube), not a machine learning or AI algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

Summary

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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 .: (201) 847-3103 Fax No. (201) 847-4858
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:

> 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.

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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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 yours.

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:

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)________________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

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.