(59 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of blood collection tubes, with no mention of AI or ML.
No
The device is used to collect and process blood for testing, not to treat a condition or for diagnosis.
No
This device is a blood collection tube used to collect, transport, and process blood for testing, not to perform the diagnostic testing itself. It's a sample collection tool, not a diagnostic instrument.
No
The device description clearly outlines physical components such as tubes, caps, and a vacuum tube holder, indicating it is a hardware device for blood collection.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the tubes are used to "collect, transport and process blood for testing plasma, serum, or whole blood for trace elements in the clinical laboratory." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a device designed to collect and prepare blood samples for laboratory testing.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is where in vitro diagnostic testing is performed.
The device is a container specifically designed to hold and prepare biological samples for subsequent in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. The Greiner VACUETTE® Trace Elements tubes with sodium heparin or no additive are used to collect, transport and process blood for testing plasma, serum, or whole blood for trace elements in the clinical laboratory.
Product codes
JKA
Device Description
VACUETTE® Tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. The VACUETTE® Trace Elements tube with sodium heparin may be used to collect a whole blood/plasma sample. The VACUETTE® Trace Elements tube with no additive may be used to collect a serum sample. The tubes are composed of clear plastic. The caps are roval blue and made of plastic and rubber: the inner cap rings are black and made of plastic. The tubes' size is 13 x 75 mm. 6mL draw. The tubes are equipped with a vacuum tube holder to assist in positioning the product when obtaining blood samples. The vacuum tube holder is composed of plastic.
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)
Two studies were conducted on the tubes – testing for presence of trace elements in the tubes using deionized water and comparison testing using blood collected from 40 blood donors. Test results for trace elements to be claimed showed no background presence of trace elements in the tubes and equivalent performance with blood samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Becton Dickinson Vacutainer® Trace Elements tube with sodium heparin
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
JAN 2 7 2003
November 27, 2002
510(K) SUMMARY
Greiner VACUETTE® Trace Elements Tubes
Greiner VACUETTE® North America. Inc. P.O Box 1026 Monroe, NC 28111
For information regarding this 510(k) Summary, please contact Greiner VACUETTE® North America, Douglas L. Harris.
Device Names:
Proprietary Name: VACUETTE® Trace Elements Tubes
Common Name: Blood Collection Tubes
Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Description:
VACUETTE® Tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. The VACUETTE® Trace Elements tube with sodium heparin may be used to collect a whole blood/plasma sample. The VACUETTE® Trace Elements tube with no additive may be used to collect a serum sample. The tubes are composed of clear plastic. The caps are roval blue and made of plastic and rubber: the inner cap rings are black and made of plastic. The tubes' size is 13 x 75 mm. 6mL draw. The tubes are equipped with a vacuum tube holder to assist in positioning the product when obtaining blood samples. The vacuum tube holder is composed of plastic.
Intended Use:
VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. The Greiner VACUETTE® Trace Elements tubes with sodium heparin or no additive are used to collect, transport and process blood for testing plasma, serum, or whole blood for trace elements in the clinical laboratory.
Substantial Equivalence:
The Greiner VACUETTE® Trace Elements tubes are substantially equivalent to the Becton Dickinson Vacutainer® Trace Elements tube with sodium heparin (pre-amendment). The blood collection tubes have the same intended use and contain the same tube material and stopper material; the VACUETTE® Trace Elements tube containing sodium heparin contains the same anticoagulant.
Two studies were conducted on the tubes – testing for presence of trace elements in the tubes using deionized water and comparison testing using blood collected from 40 blood donors. Test results for trace elements to be claimed showed no background presence of trace elements in the tubes and equivalent performance with blood samples.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Greiner Bio-One Vacuette® North America c/o Ms. Judi Smith Principal Sienna Partners, L.L.C. P.O. Box 103 Baldwin, MD 21013
JAN 2 7 2003
K023971 Re:
Trade/Device Name: Greiner VACUETTE® Trace Elements Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: November 27, 2002 Received: November 29, 2002
Dear Ms. Smith:
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. Iisting 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 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 (OS) regulation (21 CFR Part 820).
2
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions 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). 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/cdrh/dsma/dsmamain.html.
Sincerely yours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Ko2397/ 510(k) Number (if known):
Device Name: Greiner VACUETTE® Trace Elements Evacuated Blood Collection Tubes with sodium heparin or no additive
Indications For Use:
Greiner VACUETTE® Trace Elements Evacuated Blood Collection Tubes with sodium heparin or no additive are used to collect, transport and process blood for testing plasma, serum, or whole blood for trace elements in the clinical laboratory.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lan V.A. La De Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K093471
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)