(143 days)
VACUTAINER® Brand Sodium Citrate Tube N/A
Not Found
No
The summary describes a blood collection tube and its use in laboratory testing, with no mention of AI or ML technology.
No.
The device is a blood collection tube used for diagnostic purposes (coagulation assays) and does not provide therapy or treatment.
No
This device is a blood collection and preparation tube, specifically designed to prevent blood clotting for subsequent analysis. It does not perform the diagnostic analysis itself, but rather provides the sample for such analysis. The diagnostic function is performed by laboratory coagulation assays on the collected plasma.
No
The device is a physical blood collection tube made of glass and containing a chemical anticoagulant. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the blood collected in the tube is used "primarily for clinical laboratory coagulation assays." This indicates the device is used to examine specimens derived from the human body (blood) to provide information for diagnostic purposes (detecting clotting time disorders and/or monitoring patients undergoing anticoagulation therapy).
- Device Description: The description further clarifies that the collected specimen is processed (centrifuged) and the plasma is analyzed for "coagulation parameters." This analysis is performed in a clinical laboratory setting.
- Care Setting: The intended user/care setting is a "Clinical laboratory," which is a typical environment for IVD testing.
The device is a collection and processing tool for a specimen that will be used in an in vitro diagnostic test (coagulation assays). Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The VACUTAINER® Brand Sodium Citrate Pediatric Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a tube containing Sodium Citrate anticoagulant is used primarily for clinical laboratory coagulation assays.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The VACUTAINER® Brand Sodium Citrate Pediatric Tubes are sterile, glass, evacuated blood collection tubes. The tube contains 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 the coagulation parameters to detect clotting time disorders and/or 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical evaluations were performed to determine the affects of the material modification of the rubber stopper. The modified VACUTAINER® Brand Sodium Citrate Pediatric Tube demonstrated analytically and statistically equivalent results when compared to the currently marketed VACUTAINER® Brand Sodium Citrate Tube.
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.
VACUTAINER® Brand Sodium Citrate Tube N/A
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.
Not Found
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
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: | James W. Haynes
Regulatory Affairs Specialist
Telephone no.: 201) 847-5170
Fax No. (201) 847-4858 |
| • Date of Summary: | February 2, 1999 |
Device =======================================================================================================================================================================
| Trade Name: | VACUTAINER® Brand Sodium Citrate
Pediatric 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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Image /page/1/Picture/0 description: The image shows the word "CONFIDENTIAL" in large, bold, black letters. The letters are closely spaced together, filling most of the frame. The font appears to be a sans-serif typeface, and the overall impression is one of emphasis and importance.
Safety and Effectiveness Information Supporting the II. 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 E quivalence 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 VACUTAINER® Brand Sodium Citrate Pediatric Tubes are sterile, glass, evacuated blood collection tubes. The tube contains 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 the coagulation parameters to detect clotting time disorders and/or monitor patients undergoing anticoagulation therapy.
Intended Use: .
The VACUTAINER® Brand Sodium Citrate Pediatric Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a tube containing Sodium Citrate anticoagulant is used primarily for clinical laboratory coagulation assays.
Synopsis of Test Methods and Results .
Becton Dickinson VACUTAINER Systems has determined that the material modification of the rubber stopper to the VACUTAINER® Brand Sodium Citrate Pediatric Tube does not affect the performance or effectiveness of the device for its intended use. Clinical evaluations were performed to determine the affects of the modifications described herein.
The VACUTAINER® Brand Sodium Citrate Pediatric Tube was compared t the currently marketed VACUTAINER® Brand Sodium Citrate Tube. The modified VACUTAINER® Brand Sodium Citrate Pediatric Tube demonstrated analytically and statistically equivalent results.
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Substantial Equivalence .
Based on comparison of the device features, materials, and intended use, the VACUTAINER® Brand Sodium Citrate Pediatric Tube can be shown to be substantially equivalent to the commercially available predicate device.
The predicate devices, 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 |
There are no new product claims described in this 510(k) Premarket Notification.
James W. Heyns
James W. Haynes Regulatory Affairs Specialist
February 2, 1999
Date
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 3 1999
Mr. James W. Haynes Regulatory Affairs Specialist Beckton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417-1885
- Re: K991551
Trade Name: VACUTAINER® Brand Sodium Citrate Pediatric Tube Regulatory Class: II Product Code: JKA Dated: August 23, 1999 Received: August 24, 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 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). 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: General regulation (21 CFR Part 820) and that, through periodic QS 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 affect 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 (CLIA-88), this device may 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 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"(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/cdrlvdsma/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
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B. INDICATIONS FOR USE
510(k) Number (if known): K991551
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The VACUTAINER® Brand Sodium Citrate Pediatric Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a tube containing Sodium Citrate anticoagulant is used primarily for clinical laboratory coagulation assays.
Gean Coogen
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991551
(Please do not Write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Or
Over-the-Counter Use_
(Per 21 CFR § 801.109)
(Optional format 1-2-96)