(28 days)
BD Vacutainer® SST™ Plus Blood Collection tube (BD SST™)
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No
The device description and intended use focus on the physical properties and function of a blood collection tube, with no mention of AI or ML technologies.
No.
The device is used for collecting, separating, transporting, and processing blood specimens for in vitro diagnostic use, not for treating any medical condition or disease.
No
Explanation: The device is a blood collection tube used to prepare serum for laboratory analysis, not to diagnose a condition itself. The collected serum is used for "chemistry determinations for in vitro diagnostic use," meaning the diagnostic process occurs with the collected sample, not through the tube itself.
No
The device is a physical blood collection tube with a closure, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The intended use explicitly states that the tube is used "to obtain serum for chemistry determinations for in vitro diagnostic use." This is the most direct indicator.
- Device Description: The description mentions that the tube is used for "collecting, transporting, separating, and processing blood," which are all steps involved in preparing a sample for in vitro diagnostic testing.
- Performance Studies: The performance studies compare the device to a predicate device for "routine and special chemistry analytes, and selected serology and immunology analytes." These are all types of tests performed in vitro.
The core function of this device is to prepare a blood sample for analysis outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JKA
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
It is used in settings where a venous blood sample is collected by a trained healthcare worker.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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 HG. The test results demonstrated that the evaluation device's performance was substantially equivalent to the legally marketed predicate device for tested analytes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BD Vacutainer® SST™ Plus Blood Collection tube (BD SST™)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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:
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).
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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 (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.
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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