(113 days)
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No
The summary describes a blood collection tube with a rapid clotting additive, not a device that processes data or images using AI/ML.
No
The BD Vacutainer® Rapid Serum Tube Plus Blood Collection Tube is explicitly described for in vitro diagnostic use, specifically for collecting, separating, transporting, and processing venous blood specimens to obtain serum for chemistry determinations. It does not treat or prevent any disease or condition.
No
This device is a blood collection tube used to obtain serum for chemistry determinations, not to diagnose a condition itself. It's a tool used in the process of generating data that may be used for diagnostic purposes by a healthcare professional.
No
The device is a physical blood collection tube, not a software application. The description focuses on the tube's physical properties and function in collecting and processing blood.
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 a clear indication that the device is intended to be used outside of the body to analyze a sample for diagnostic purposes.
- 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 summary of performance studies mentions "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 further supports the use of the device in a laboratory setting for diagnostic analysis.
The definition of an IVD is a medical device that is intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. The BD Vacutainer® Rapid Serum Tube Plus Blood Collection Tube fits this definition.
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Intended Use / Indications for Use
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.
Product codes
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 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.
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
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
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.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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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
.
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BD Vacutainer® Rapid Serum Tube Plus Trade Name: Blood Collection Tube
May 1, 2009 -
JKA (Tubes, vials, systems, serum separators, Classification Name: . blood collection)
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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:
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.
1
> 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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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 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.
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