(18 days)
Preamendment
Not Found
No
The 510(k) summary describes a blood collection tube and its intended use for trace element testing. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on mechanical and functional testing of the tube itself.
No
This device is a blood collection tube used for diagnostic testing of trace elements, not for treating a disease or condition.
No
The device collects and processes blood for trace element testing, but it does not perform the diagnostic analysis itself. It is a collection and transport device for samples intended for diagnostic testing.
No
The device description clearly indicates it is a physical blood collection tube made of plastic with a closure and additives, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the collected blood is "used for trace element testing." This testing is performed in vitro (outside the body) on a biological specimen (blood) to provide information for diagnostic purposes (determining the levels of trace elements).
- Device Description: The device is a "plastic evacuated blood collection tube" with additives (Silica Clot Activator or K2EDTA). These are standard components of devices used for collecting and preparing biological samples for in vitro analysis.
- Predicate Devices: The predicate devices listed are also described as "Trace Element" tubes, further reinforcing their use in in vitro diagnostic testing.
The core function of this device is to collect and prepare a biological sample for subsequent in vitro analysis to aid in diagnosis or monitoring. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube is used for trace element testing (e.g., Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc).
Product codes
JKA
Device Description
The device description of the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are as follows:
- Plastic tube (13x100, 6ml)
- Tube closure: Royal blue Hemogard™ closure
- Additive: Silica Clot Activator or K2EDTA
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)
Extensive mechanical and functional testing was performed to demonstrate the devices' safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Preamendment
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
KO41071
Attachment 4
MAY 1 4 2004
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 CFR § 807.92
Establishment:
- Address: .
- Registration Number: .
Contact Person: .
- BD Diagnostics, Preanalytical Systems 1 Becton Drive Franklin Lakes, NJ 07417-1885 2243072 Jing Zhang Regulatory Affairs Manager Telephone no .: 201-847-4717 Fax No. 201-847-4858 4/23/04
- Date of Summary: .
Device:
- Trade Name: .
- Classification Name: .
- Classification: .
- Performance Standards: .
BD Vacutainer® Trace Element Serum Plus Tube BD Vacutainer® Trace Element K2EDTA Plus Tube
Evacuated Blood Collection Tube Class II
None Established under 514 of the Food, Drug and Cosmetic Act
Page 1 of 2
1
CONFIDENTIAL
II Effectiveness Information Supporting Substantial Equivalence
-
Device Description �
The device description of the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are as follows: -
Plastic tube (13x100, 6ml)
-
Tube closure: Royal blue Hemogard™ closure
-
Additive: Silica Clot Activator or K2EDTA
-
Intended Use .
The BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube is used for trace element testing (e.g., Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc).
- Synopsis of Performance Study Results .
Extensive mechanical and functional testing was performed to demonstrate the devices' safety and effectiveness.
III. Predicate Device Summary Table
Based on comparison of the device features, materials, intended use and performance, the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are shown to be substantially equivalent to the commercially available predicate devices indicated in the table below.
| Manufacturer | Predicate Device | 510(k) Number |
|---|---|---|
| Becton, Dickinson and | ||
| Company | BD Vacutainer® Trace Element Serum Glass | |
| Tube | Preamendment | |
| BD Vacutainer® Trace Element Na2EDTA | ||
| Glass Tube |
Jie 52
Date
4/22/14
Pages of 2.
Jing Zhang Requlatory Affairs Manager BD Diagnostics, Preanalytical Systems Becton, Dickinson and Company
2
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 4 2004
Ms. Jing Zhang Regulatory Affairs Manager Becton Dickinson & Co. BD Diagnostics, PreAnalytical System 1 Becton Drive Franklin Lakes, NJ 07417
K041071 Re:
Trade/Device Name: The BD Vacutainer®Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: April 23, 2004 Received: April 26, 2004
Dear Ms. 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 cither 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotter notification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, Ir you stions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Jean M. Cooper, US, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K040171
DEvICE NAME: The BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube
INDICATIONS FOR USE:
The BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube is used for trace element testing (e.g., Arsenic Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, adduni,
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KD4/0671
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