(60 days)
Not Found
Not Found
No
The 510(k) summary describes a blood collection tube and its anticoagulant properties. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies. The benefits described relate to the physical properties of the tube and its impact on safety and specimen integrity.
No
This device is used for collecting and processing blood samples for laboratory testing, not for treating a medical condition.
No
Explanation: This device is a blood collection tube used to prepare blood samples for coagulation assays. It is a tool used in the diagnostic process, but it does not perform the diagnosis itself. The diagnosis is made by analyzing the "coagulation parameters" from the plasma, which this tube helps to collect and prepare.
No
The device is a physical blood collection tube with chemical additives, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the collected blood specimen "may be used for clinical laboratory coagulation assays." This indicates the device is used to prepare a sample for diagnostic testing performed in a laboratory.
- Device Description: The description clarifies that the collected plasma is "analyzed for coagulation parameters to detect clotting time disorders and to monitor patients undergoing anticoagulation therapy." This directly relates to diagnostic purposes.
- Performance Studies: The performance studies compare the device to a predicate device used for the same purpose (collecting blood for coagulation assays), further supporting its diagnostic nature.
The device is a blood collection tube with an anticoagulant, which is a common component used in the process of performing in vitro diagnostic tests on blood samples.
N/A
Intended Use / Indications for Use
The BD Vacutainer™ Safety Coagulation tube is an evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. The benefits of a safety plastic coagulation tube with Hemogard Safety Closure Assembly are:
- reduced risk of specimen tube breakage .
- . reduced exposure to blood by laboratory personnel and to minimize blood splatter during stopper removal
These benefits lead to increased safety of laboratory personnel and reduced necessity of repeat specimen collection.
Product codes
GIM
Device Description
The BD Vacutainer™ Safety Coagulation tubes are sterile, plastic, evacuated blood collection tubes. The tubes contain 0.109M or 0.129M Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. The specimen is centrifuged and the plasma portion is analyzed for coagulation parameters to detect clotting time disorders and to monitor patients undergoing anticoagulation therapy. The benefits of a plastic tube decrease the occurrence of accidental breakage, increases the safety of laboratory personnel and reduces the necessity of repeat specimens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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 evaluations were performed to determine the safety and efficacy of the BD Vacutainer™ Safety Coagulation tube. The BD Vacutainer™ Safety Coagulation tube (plastic) was compared to the currently marketed VACUTAINER™ Brand Sodium Citrate Tube (glass). The results of the clinical evaluation demonstrated that the BD Vacutainer™ Safety clinical evaluation demonstition illy equivalent results when compared to Coagulation tube provides crimidale) equalizare Tube for Normal, Warfarin, Heparin and other patient donors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VACUTAINER™ Brand Sodium Citrate Tube
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary Of Safety and Effectiveness
- I. 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: | Becton Dickinson VACUTAINER Systems
1 Becton Drive
Franklin Lakes, NJ 07417-1885 |
|------------------------|----------------------------------------------------------------------------------------------------------|
| • Registration Number: | 2243072 |
| • Contact Person: | Keith M. Smith
Director, Regulatory Affairs
Telephone No.:(201) 847-5837
Fax No. (201) 847-7040 |
| • Date of Summary: | September 28, 2001 |
Device
- Trade Name: BD Vacutainer™ Safety Coagulation tube . Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
- . Classification: Class II
- Performance Standards: None Established under 514 of the Food, Drug and Cosmetic Act
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II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
Substantial Equivalence Declaration:
The term "Substantial Equivalence" as used in this 510(k) Premarket Notification is limited to the definition of Substantial Equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR & 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of, substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
- . Device Description:
The BD Vacutainer™ Safety Coagulation tubes are sterile, plastic, evacuated blood collection tubes. The tubes contain 0.109M or 0.129M Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. The specimen is centrifuged and the plasma portion is analyzed for coagulation parameters to detect clotting time disorders and to monitor patients undergoing anticoagulation therapy. The benefits of a plastic tube decrease the occurrence of accidental breakage, increases the safety of laboratory personnel and reduces the necessity of repeat specimens.
. Intended Use:
The BD Vacutainer™ Safety Coagulation tube is an evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. The benefits of a safety plastic coagulation tube with Hemogard Safety Closure Assembly are:
- reduced risk of specimen tube breakage .
- . reduced exposure to blood by laboratory personnel and to minimize blood splatter during stopper removal
These benefits lead to increased safety of laboratory personnel and reduced necessity of repeat specimen collection.
- Synopsis of Test Methods and Results .
Clinical evaluations were performed to determine the safety and efficacy of the BD Vacutainer™ Safety Coagulation tube. The BD Vacutainer™ Safety Coagulation tube (plastic) was compared to the currently marketed VACUTAINER™ Brand Sodium Citrate Tube (glass). The results of the
2
clinical evaluation demonstrated that the BD Vacutainer™ Safety clinical evaluation demonstition illy equivalent results when compared to Coagulation tube provides crimidale) equalizare Tube for Normal, Warfarin, Heparin and other patient donors.
- Substantial Equivalence .
Based on comparison of the device features, materials, and intended use, the BDP Based on comparison on the device havenes, macemes, which substantially equivalent to the commercially available predicate device.
The predicate device, K number, and clearance date are identified below:
| Manufacturer | Predicate Device | K-Number | Clearance Date |
|---|---|---|---|
| Becton Dickinson | |||
| VACUTAINER™ | |||
| Systems | VACUTAINER™ | ||
| Brand Sodium | |||
| Citrate Tube | N/A | Pre-Amendment Device | |
| and, therefore, exempt | |||
| from premarket | |||
| notification requirements | |||
| according to the MDA of | |||
| 1976 |
لغد S.D
Keith M. Smith Director, Regulatory Affairs
11/30/01
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved, overlapping shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 01 2002
Mr. Keith M. Smith Associate Director, Regulatory Affairs BD Pharmaceutical Systems Becton Dickinson and Company 1 Becton Drive Mail Code 440 Franklin Lakes, New Jersey 07417-1880
Re: K013971
Trade/Device Name: BD Vacutainer™ Safety Coagulation Tube Regulation Number: 21 CFR § 862.1675 Regulation Name: Tubes, Vials, Systems, Serum Separators, Blood Collection Regulatory Class: II Product Code: GIM Dated: November 28, 2001 Received: December 3, 2001
Dear Mr. Smith:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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B. INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
BD Vacutainer™ Safety Coagulation tube Device Name:
Indications for Use:
The BD Vacutainer™ Safety Coagulation tube is a plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. The benefits of a safety plastic coagulation tube with Hemogard Safety Closure Assembly are:
- reduced risk of specimen tube breakage .
- reduced exposure to blood by laboratory personnel and to minimize blood . splatter during stopper removal
These benefits lead to increased safety of laboratory personnel and reduced necessity of repeat specimen collection.
Aurhini Boutta
rsion Sign Sign of Clinical Laboratory Devices
(Please do not Write below this line-continue on another 510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the-Counter Use Or
(Per 21 CFR § 801.109)
(Optional format 1-2-96)