(47 days)
N/A
Not Found
No
The summary describes a blood collection tube with a specific additive for coagulation assays. There is no mention of any computational analysis, algorithms, or learning processes.
No.
The device is used for collecting, transporting, and processing blood for diagnostic laboratory coagulation assays, not for treating a condition or disease.
No
This device is an evacuated blood collection tube, designed for collecting, transporting, and processing blood for clinical laboratory coagulation assays. It is a tool used to prepare a specimen for diagnostic testing, not a diagnostic device itself.
No
The device description clearly states it is a sterile, glass, evacuated blood collection tube containing chemical additives, which are physical components, not software.
Based on the provided information, the VACUTAINER® Brand CTAD Tube is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the collected specimen "may be used for clinical laboratory coagulation assays." This indicates the device is used to prepare a sample for diagnostic testing performed outside the body.
- Device Description: The description details how the collected blood is processed (centrifuged) and the plasma portion is analyzed for "coagulation parameters to detect clotting time disorders and to monitor patients undergoing anticoagulation therapy." This directly relates to diagnostic purposes.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is the typical setting for performing in vitro diagnostic tests.
- Performance Studies: The performance studies compare the device to another blood collection tube used for coagulation assays and evaluate key metrics like aPTT, Heparin Xa, and Platelet Factor 4, which are all parameters measured in in vitro diagnostic tests for coagulation.
The device is designed to collect and prepare a biological specimen (blood) for subsequent analysis in a clinical laboratory to obtain information about a patient's health status (coagulation disorders, monitoring therapy). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VACUTAINER® Brand CTAD Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. The CTAD additive, a combination of a buffered sodium citrate, theophylline, adenosine and dipyridamole, provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.
Product codes
JKA
Device Description
The VACUTAINER® Brand CTAD Tubes are sterile, glass, evacuated blood collection tubes. The tubes contain 0.109M Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. In addition to citrate, the CTAD tube contains theophylline, adenosine and dipyridamole (inhibitors of platelet activation). 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.
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
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Summary of Performance Studies
Clinical evaluations were performed to determine the safety and efficacy of the VACUTAINER® Brand CTAD Tube. The VACUTAINER® Brand CTAD Tube was compared to the currently marketed VACUTAINER® Brand Sodium Citrate Tube. The results of the clinical evaluation demonstrate that the VACUTAINER® Brand CTAD Tube provides clinically equivalent results when compared to the VACUTAINER® Brand Sodium Citrate Tube for Normal Donors and Warfarin Donors. The superior performance of the VACUTAINER® Brand CTAD Tube was distinctly demonstrated for patients undergoing heparin anticoagulant therapy. For the Heparin Donors, the tube demonstrated clinically non-equivalent aPTT, Heparin Xa and Platelet Factor 4 results when compared to the VACUTAINER® Brand Sodium Citrate Tube. These expected results clearly illustrated the effects of the CTAD additive to prevent platelet activation and subsequent release of platelet factor 4. The reduced levels of platelet factor 4 minimized the neutralization of heparin in the sample, thus leading to longer aPTT clotting times, higher Heparin Xa results and lower Platelet Factor 4 results. This stabilization of heparin in the collected sample allows for a more accurate monitoring of anticoagulant therapy in heparinized patients.
Key Metrics
Not Found
Predicate Device(s)
N/A
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
K99/120
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
2243072
Establishment:
- A d d re s s : .
- Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, NJ 07417-1885
- . Registration Number:
- . Contact Person:
James W. Haynes Regulatory Affairs Specialist Telephone No .: 201) 847-5170 Fax No. (201) 847-4858
- . Date of Summary: March 31, 1999
Device
.
.
- . Trade Namc: VACUTAINER® Brand CTAD Tube
- Classitication Name: Tubes, Vials, Systems, Scrum Separators, Blood Collection
- . Classification: Class II
- Performance Standards: None Established under 514 of the Food, Drug and Cosmetic Act
1
- 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 upplication by the couris.
-
Device Description: .
The VACUTAINER® Brand CTAD Tubes are sterile, glass, evacuated blood collection tubes. The tubes contain 0.109M Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. In addition to citrate, the CTAD tube contains theophylline, adenosine and dipyridamole (inhibitors of platelet activation). 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. -
Intended Use:
The VACUTAINER® Brand CTAD Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. The CTAD additive, a combination of a buffered sodium citrate, theophylline, adenosine and dipyridamole, provides an anticoagulated specimen that may be used for clinical laboratory coagulation аззауз. -
. Synopsis of Test Methods and Results
Clinical evaluations were performed to determine the safety and efficacy of the VACUTAINER® Brand CTAD Tube. The VACUTAINER® Brand CTAD Tube was compared to the currently marketed VACUTAINER® Brand Sodium Citrate Tube. The results of the clinical evaluation demonstrate that the VACUTAINER® Brand CTAD Tube provides clinically equivalent results when compared to the VACUTAINER® Brand Sodium Citrate Tube for Normal Donors and Warfarin Donors. The superior performance of the VACUTAINER® Brand CTAD Tube was distinctly demonstrated for patients undergoing heparin anticoagulant therapy. For the Heparin Donors, the tube demonstrated clinically non-equivalent aPTT, Heparin Xa and Platelet Factor 4 results when compared to the VACUTAINER® Brand Sodium Citrate Tube. These expected results clearly illustrated the effects of the CTAD additive to provent platelet activation and subsequent release of platelet factor 4. The reduced levels of platelet factor 4 minimized the neutralization of heparin in the sample,
2
thus leading to longer aPT" clotting times, higher Heparin Xa results and lower Platelet Factor 4 results. This stabilization of heparin in the collected sample allows for a more accurate monitoring of anticoagulant therapy in heparinized patients.
- Substantial Equivalence ◆
Based on comparison of the device features, materials, and intended use, the VACUTAINER® Brand CTAD Tube can be shown to be substantially cquivalent to the commercially available prodicate 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 |
James W. Haynes
James W. Ilayncs Regulatory Affairs Specialist
March 31, 1999
Date
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized eagle with three stripes forming its body, symbolizing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
MAY 1 9 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. James W. Haynes Regulatory Affairs Specialist Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417-1885
Re: K991120
Trade Name: VACUTAINER® Brand CT AD Tube Regulatory Class: II Product Code: JKA Dated: March 31, 1999 Received: April 2, 1999
Dear Mr. Haynes:
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 stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment datc of the Medical Device Amendments, or to devices that have heen reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 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: Gencral regulation (21 CFR Part 820) and that, through periodic ()S inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not allect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CIJA-88), this device may Onder the Chilical Laboratory Improvise.
require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his icter will anow you to oogin martoung your device of your device to a legally marketed nothication. The PDA Inding of sunnantal equivalize and thus, permits your device to proceed to the market.
If you desirc specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific acvice to: your do rises), please contact the Office of Compliance at additionally 807.10 for mi vitto diagnosis on the promotion and advertising of your device, (201) 594-4360. Tructionally, roll processes (301) 594-4639. Also, please note the regulation prease contact the Office of Compilance (start notification"(21 CFR 807.97). Other general enfined, "Wissoranding by reference to president to promotion from the Division of Small Information on your responsibility the number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrls/dsma/dsmamain.html"
Sincerely yours,
Steven Autman
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): _ K991120
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The VACUTAINER® Brand CTAD Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. The CTAD additive, a combination of a buffered sodium cirate, theophyline, adenosine and dipyridamole, provides an anticoagulated specimen that may be used for clinical laboratory
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991120
(Please do not Write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use 1
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Pct 21 CFR § 801.109)
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