(28 days)
Not Found
No
The device is a blood collection tube and the description focuses on its physical components and function in separating plasma. There is no mention of any computational or analytical capabilities that would involve AI/ML.
No
The device is for collecting, transporting, and processing blood for clinical laboratory assays, not for treating a disease or condition.
No
Explanation: This device is a blood collection tube used to prepare blood samples for laboratory assays. It does not perform a diagnostic function itself, but rather facilitates the collection and processing of samples that will then be used for diagnostic testing.
No
The device description clearly outlines physical components (plastic tube, closure assembly, gel barrier) and its function involves physical processes (blood collection, centrifugation, mechanical separation). It is a hardware device.
Based on the provided information, the BD Vacutainer™ PLUS PST II™ Tube is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the blood collected in this tube is "used for clinical laboratory assays involving the use of patient plasma." This directly aligns with the definition of an IVD, which are devices used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details how the tube is used to collect, transport, and process blood for obtaining plasma, which is then used for "clinical laboratory assays."
- Clinical Laboratory Setting: The intended user/care setting is the "clinical laboratory," which is where IVD testing is performed.
- Performance Studies: The summary of performance studies describes a clinical evaluation comparing this tube to a predicate device for "chemistry analyte results," further indicating its use in diagnostic testing.
Therefore, the BD Vacutainer™ PLUS PST II™ Tube fits the criteria of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD Vacutainer™ PLUS PST II™ Tube is a lithium heparin coated plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS PST II™ Tube is used for clinical laboratory assays involving the use of patient plasma.
Product codes
JKA
Device Description
The Vacutainer™ PLUS PST II™ Tubes are sterile, plastic, evacuated blood collection tubes. The Vacutainer™ PLUS PST II™ Tube consists of: (1) a closure assembly. (2) an inert acrylic gel mechanical barrier, and (3) a lithium heparin coated plastic tube. The specimen is centrifuged and the barrier material forms at the plasma interface, mechanically separating the plasma from cells. The plasma portion is used for clinical laboratory assays involving the use of patient plasma. 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies
Clinical evaluations were performed to determine the safety and efficacy of the BD Vacutainer™ PLUS PST II™ Tube. The BD Vacutainer™ PLUS PST II™ Tube was compared to the currently marketed BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube. The results of the clinical evaluation demonstrated that the BD Vacutainer™ PLUS PST II™ Tube provides clinically equivalent chemistry analyte results when compared to the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube.
Key Metrics
Not Found
Predicate Device(s)
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
JUL 2 9 2002
J. 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: | BD VACUTAINER Systems, Preanalytical Solutions
1 Becton Drive, MC 300
Franklin Lakes, NJ 07417-1885 |
|------------------------|-----------------------------------------------------------------------------------------------------------|
| • Registration Number: | 2243072 |
| • Contact Person: | Jing Zhang
Manager Regulatory Affairs
Telephone No.:(201) 847-4717
Fax No. (201) 847-4858 |
| • Date of Summary: | July 24, 2002 |
Device
.
- Trade Name: BD Vacutainer™ PLUS PST II™ Tube
- Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
- Classification: Class II .
- None Established under 514 of the Food, Performance Standards: . Drug and Cosmetic Act
1
- Safety and Effectiveness Information Supporting the Substantial Equivalence II. Determination
> Device Description:
The Vacutainer™ PLUS PST II™ Tubes are sterile, plastic, evacuated blood collection tubes. The Vacutainer™ PLUS PST II™ Tube consists of: (1) a closure assembly. (2) an inert acrylic gel mechanical barrier, and (3) a lithium heparin coated plastic tube. The specimen is centrifuged and the barrier material forms at the plasma interface, mechanically separating the plasma from cells. The plasma portion is used for clinical laboratory assays involving the use of patient plasma. 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™ PLUS PST II™ Tube is a lithium heparin coated plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS PST II™ Tube is used for clinical laboratory assays involving the use of patient plasma.
-
Claims:
The PLUS PST II™ Tube: (1) provides improved plasma quality vs. the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube: (2) provides selected analyte stability up to twenty-four hours after centrifugation; and (3) provides stability for up to two hours after centrifugation for the following cardiac analytes: troponin I, creatine kinase MB fraction (CKMB), and myoglobin.
> Synopsis of Test Methods and Results
Clinical evaluations were performed to determine the safety and efficacy of the BD Vacutainer™ PLUS PST II™ Tube. The BD Vacutainer™ PLUS PST II™ Tube was compared to the currently marketed BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube. The results of the clinical evaluation demonstrated that the BD Vacutainer™ PLUS PST II™ Tube provides clinically equivalent chemistry analyte results when compared to the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube.
2
> Substantial Equivalence
Based on a comparison of the device features, materials, and intended use, the BD Vacutainer™ PLUS PST II™ Tube are substantially equivalent to the commercially available predicate device. The only difference between the predicate Vacutainer™ PLUS PST™ Tubes and the Vacutainer™ PLUS PST IITM Tubes is the acrylic gel material. The predicate device, K number, and clearance date are identified below:
Manufacturer | Predicate Device | K-Number | Clearance Date |
---|---|---|---|
BD VACUTAINER™ Systems | VACUTAINER™ Brand PST™ PLUS Tube | K945952 | 1/18/95 |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 9 2002
Mr. Jing Zhang Manager, Regulatory Affairs Becton, Dickinson and Company 1 Becton Drive, MC 300 Franklin Lakes, NJ 07417-1885
Re: K022130
Trade/Device Name: BD Vacutainer136 Plus PST IITM Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: June 28, 2002 Received: July 1, 2002
Dear Mr. Zhang:
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 -
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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
5
B. INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Koz2130
Device Name: BD Vacutainer™ PLUS PST II™ Tube
Indications for Use:
The BD Vacutainer™ PLUS PST II™ Tube is a lithium heparin coated plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS PST II™ Tube is used for clinical laboratory assays involving the use of patient plasma.
(Please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE) ﻟﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ Prescription Use Or Over-the-Counter Use (Optional format 1-2-96) (Per 21 CFR § 801.109)
Hean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KO 22130