(91 days)
Not Applicable
No
The summary describes a blood collection tube and its components, with no mention of software, algorithms, or any technology related to AI or ML.
No.
This device is designed for collecting, transporting, separating, and processing blood samples for diagnostic testing, not for providing therapy or treatment to a patient.
No
This device is a blood collection tube used for collecting, transporting, and processing blood samples. While these samples can then be used for diagnostic testing (e.g., immunohematology testing like ABO Grouping, Rh typing, and antibody screening), the device itself does not perform the diagnostic analysis but rather facilitates the collection of the sample for such analysis.
No
The device description clearly outlines physical components such as plastic tubes, closure assemblies, and chemical coatings (EDTA, silica clot activator), indicating it is a hardware device for blood collection and processing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the blood collected in these tubes "can be used for immunohematology testing including ABO Grouping, Rh typing and antibody screening which requires red cells and plasma or serum." These are laboratory tests performed on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The device is a blood collection tube designed to collect, transport, separate, and process blood. This is a fundamental step in the process of performing in vitro diagnostic tests.
- Clinical Testing: The document mentions clinical testing was performed to evaluate the effectiveness of the tubes for immunohematology testing, further supporting their use in a diagnostic context.
While the document doesn't explicitly use the term "In Vitro Diagnostic," the intended use and the nature of the device clearly align with the definition of an IVD. It is a device used in vitro (outside the body) to examine specimens (blood) from the human body to obtain information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The VACUTAINER® Brand PLUS Tube with EDTA anticoagulant and the VACUTAINER Brand PLUS Serum Tube are evacuated blood collection tubes which provides a means collecting, transporting and processing blood in a closed plastic tube. Blood collected in a tube containing EDTA anticoagulant, VACUTAINER® Brand PLUS Tube with EDTA anticoagulant, is used primarily for clinical laboratory hematology studies. The VACUTAINER® Brand PLUS Serum Tube containing Silica activator is used primarily in clinical laboratory testing for chemistry assays.
In addition, the blood collected and processed in the VACUTAINER® Brand PLUS with EDTA anticoagulant and the VACUTAINER® Brand PLUS Serum Tube can be used immunohematology testing including ABO grouping, Rh typing and antibody screening which requires red cells and plasma or serum.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The VACUTAINER® Brand PLUS Tube with EDTA and the VACUTAINER PLUS Serum Tube are evacuated plastic blood collection tubes for collecting, transporting and processing blood in a closed plastic tube. The VACUTAINER® Brand PLUS Tube with EDTA consists of closure assembly, a plastic tube and EDTA coating (dipotassium). The VACUTAINER PLUS Serum Tube consists of closure assembly, a plastic tube and silica clot activator.
The standard closure assembly is a basic rubber stopper. The tubes are also available with the VACUTAINER® Hemogard Closure Assembly, which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. The Hemogard closure assembly, intended to reduce user exposure to blood, was described in 510(k) Premarket Notification K945952 that received FDA clearance on January 18, 1995. All stopper/closures are color coded to reflect additive type (see the chart VACUTAINER® Tube Stopper/Closure Color Code Cross Reference located in the Product Insert, Attachment D)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing to evaluate the effectiveness of the additional Indications for Use described in premarket notification was performed. The results of the clinical evaluation demonstrate that the VACUTAINER® Brand PLUS (plastic) EDTA and PLUS Serum tubes provide equivalent results compared to the VACUTAINER® Brand (glass) Serum and EDTA tubes for immunohematology testing including ABO Grouping, Rh typing and antibody screening which requires red cells and plasma or serum.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Applicable
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.
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).
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
JUN | 7 1998
K981013
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
General Information I
This Summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92
| Establishment:
• Address: | Becton Dickinson VACUTAINER Systems
1 Becton Drive
Franklin Lakes, NJ 07417-1885 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| • Registration Number: | 2243072 |
| • Contact Person: | Eileen Schweighardt
Regulatory Affairs Manager
Telephone no.: 201 - 847 - 4570
Facsimile no.: 201 - 847 - 4858 |
| • Date of Summary: | March, 1998 |
| Device Name:
• Trade Name: | VACUTAINER® Brand PLUS Tube
with EDTA Anticoagulant and
VACUTAINER® Brand PLUS Serum Tube |
| • Classification Name : | Blood Specimen Collection Device |
| • Classification: | Class II |
| • Performance Standards: | None Established under 514 of
the Food, Drug and Cosmetic Act |
II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination Substantial Equivalence Declaration: The term "Substantial Equivalence" is used in this 510(k) Premarket Notification is limited to the definition of Substantial Equivalence as 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 apporval or reclassification.
1
- · Device Description
The VACUTAINER® Brand PLUS Tube with EDTA and the VACUTAINER PLUS Serum Tube are evacuated plastic blood collection tubes for collecting, transporting and processing blood in a closed plastic tube. The VACUTAINER® Brand PLUS Tube with EDTA consists of closure assembly, a plastic tube and EDTA coating (dipotassium). The VACUTAINER PLUS Serum Tube consists of closure assembly, a plastic tube and silica clot activator.
The standard closure assembly is a basic rubber stopper. The tubes are also available with the VACUTAINER® Hemogard Closure Assembly, which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. The Hemogard closure assembly, intended to reduce user exposure to blood, was described in 510(k) Premarket Notification K945952 that received FDA clearance on January 18, 1995. All stopper/closures are color coded to reflect additive type (see the chart VACUTAINER® Tube Stopper/Closure Color Code Cross Reference located in the Product Insert, Attachment D)
· Intended Use
The VACUTAINER® Brand PLUS Tube with EDTA anticoagulant and the VACUTAINER Brand PLUS Serum Tube are evacuated blood collection tubes which provides a means collecting, transporting and processing blood in a closed plastic tube. Blood collected in a tube containing EDTA anticoagulant, VACUTAINER® Brand PLUS Tube with EDTA anticoagulant, is used primarily for clinical laboratory hematology studies. The VACUTAINER® Brand PLUS Serum Tube containing Silica activator is used primarily in clinical laboratory testing for chemistry assays.
In addition, the blood collected and processed in the VACUTAINER® Brand PLUS with EDTA anticoagulant and the VACUTAINER® Brand PLUS Serum Tube can be used immunohematology testing including ABO grouping, Rh typing and antibody screening which requires red cells and plasma or serum.
· Synopsis of Test Methods and Results
Clinical testing to evaluate the effectiveness of the additional Indications for Use described in premarket notification was performed. The results of the clinical evaluation demonstrate that the VACUTAINER® Brand PLUS (plastic) EDTA and PLUS Serum tubes provide equivalent results compared to the VACUTAINER® Brand (glass) Serum and EDTA tubes for immunohematology testing including ABO Grouping, Rh typing and antibody screening which requires red cells and plasma or serum.
2 of 3
2
· Substantial Equivalence
Becton Dickinson VACUTAINER Systems believes that the VACUTAINER® Brand PLUS Tube with EDTA and VACUTAINER® Brand PLUS Serum Tube with the expanded Indications for Use is substantially equivalent to a commercially available blood collection tube. Clinical testing, as described in this premarket notification, demonstrates equivalent performance and effectiveness and supports the determination of substantial equivalence. The predicate devices, manufacturer, K number and clearance date are identified below:
| Manufacturer | Predicate Device | K-Number | Clearance Date |
|---|---|---|---|
| VACUTAINER | |||
| Systems | VACUTAINER® | ||
| Brand Serum Tube | Not | ||
| Applicable | Pre-Amendment Device and, therefore, | ||
| exempt from premarket notification | |||
| requirements according to the MDA of |
- |
| VACUTAINER
Systems | VACUTAINER®
Brand Tube with EDTA
Anticoagulant | Not
Applicable | Pre-Amendment Device and, therefore,
exempt from premarket notification
requirements according to the MDA of - |
Elen Schuyraon
Eileen Schweighardt Regulatory Affairs Manager Regulatory Affairs Department
March 16, 1998 Date
3 of 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings.
JUN 17 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Eileen Schweighardt Regulatory Affairs Manager Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417
Re : K981013 VACUTAINER Brand (PLUS) Plastic Blood Collection Tube with EDTA Anticoagulant and VACUTAINER Brand PLUS (Plastic) Serum Tube Regulatory Class: II Product Code: JKA Dated: March 17, 1998 March 18, 1998 Received:
Dear Ms. Schweighardt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use regulated by CDRH 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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act The general controls provisions of the Act include (Act) . requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
In addition, we have determined that your indications for use which includes immunohematology testing for ABO grouping, Rh typing and antibody screening are subject to requlation by the Center for Biologics (CBER) .
Our substantially equivalent determination does not apply to the indications for use regulated by CBER. CBER is reviewing BK980011 for the immunohematology claims. For information on applicable Agency requirements for marketing this product, we suggest you contact:
Mary Gustafson HFM-370, Room 200 N. Woodmont Center for Biologics Evaluation and Research Food and Druq Administration, Rockville, MD 20852 (301) 827-3524
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal
4
Page 2 - Ms. Schweighardt
Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action.
In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device indicated for uses regulated by CDRH in your 510(k) premarket notification although we recommend that you first contact Ms. Kochman from CBER at (301) 827-3524 before marketing your product with the immunohematology claims regulated by CBER. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
S. Dutra
Steven I. Gutman, MD, MBA Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
5
ATTACHMENT I
Image /page/5/Picture/1 description: The image is a black and white photograph. The image is mostly black, with some white areas. The image is blurry and out of focus. It is difficult to make out any specific details in the image.
Kg81013
Device Name: VACUTAINER® Brand PLUS Tube with EDTA Anticoagulant and VACUTAINER® Brand PLUS Serum Tube
Indications for Use:
510(k) Number (if known):_
The VACUTAINER® Brand PLUS (plastic) Tube with EDTA and VACUTAINER® Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube. When the tube is used together with VACUTAINER® Brand Needles and Holders, it is a closed system for the collection of venous blood with the same indications as described herein.
Blood collected in PLUS EDTA and PLUS Serum tubes can be used for immunohematology testing including ABO Grouping, Rh typing and antibody screening which requires red cells and plasma or serum.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﮨﮯ Prescription Use_ OR (Per 21 CFR 801.109)
Over-the-Counter Use
(Optional Format 1-2-96)
Clare Sliva
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _