(27 days)
K# 960857
Not Found
No
The summary describes a blood collection tube and its components, with no mention of AI or ML technology.
No.
This device is used for collecting, transporting, and processing blood samples for in vitro diagnostic testing in a clinical laboratory, not for treating or diagnosing a disease or condition in a patient.
No
The device is used to collect, transport, and process blood samples, which are then used for testing. It is a tool for diagnostic procedures, but not a diagnostic device itself as it does not perform any diagnostic analysis or provide a diagnosis.
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.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the tubes are used to "collect, transport and process blood for testing plasma or whole blood in the clinical laboratory." This directly aligns with the definition of an IVD, which are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description further supports this by detailing the components used for blood collection and processing for laboratory testing.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is a typical setting for IVD use.
- Performance Studies: The mention of a study conducted on blood samples and testing of analytes further indicates the device's role in diagnostic testing.
Therefore, the VACUETTE® tubes with sodium heparin, as described, are clearly intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The Greiner VACUETTE® blood collection tube with sodium heparin additive is an evacuated blood collection device that is used for the collection of venous blood. The VACUETTE® Tube is used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.
VACUETTE® tubes with sodium heparin are used to collect, transport and process blood for testing plasma or whole blood 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® tube with sodium heparin may be used to collect a whole blood/plasma sample. The tube is composed of clear plastic. The cap is made of plastic and rubber. The tube size is 13 x 75 mm. The tube is 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
clinical laboratory
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)
A study was conducted on blood collected from 40 donors into each type of tube. Test results of 27 analytes commonly tested in plasma showed equivalent performance of the two anticoagulants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K# 960857
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
Mav 31, 2001
510(K) SUMMARY
Greiner VACUETTE® Evacuated Blood Collection Tubes with Sodium Heparin
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® Evacuated Blood Collection Tube with Sodium Heparin |
|---|---|
| Common Name: | Blood Collection Tube with Sodium Heparin |
| 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® tube with sodium heparin may be used to collect a whole blood/plasma sample. The tube is composed of clear plastic. The cap is made of plastic and rubber. The tube size is 13 x 75 mm. The tube is 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:
The Greiner VACUETTE® blood collection tube with sodium heparin additive is an evacuated blood collection device that is used for the collection of venous blood. The VACUETTE® Tube is used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.
Substantial Equivalence:
The Greiner VACUETTE® tube with sodium heparin has been found to be substantially equivalent to the Greiner VACUETTE® tube with lithium heparin (K# 960857). Both blood collection tubes have the same intended use and contain the same tube material and stopper material. The tubes have different additives. The predicate device, Greiner VACUETTE® plasma tube with lithium heparin, contains lithium heparin as the anticoaqulant. The Greiner VACUETTE® plasma tube with sodium heparin contains sodium heparin as the anticoagulant.
A study was conducted on blood collected from 40 donors into each type of tube. Test results of 27 analytes commonly tested in plasma showed equivalent performance of the two anticoagulants.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Greiner Bio-One Vacuette North America c/o Ms. Judith J. Smith Principal Suenna Partners, L.L.C. P.O. Box 103 Baldwin, MD 21013
JUN 2 8 2001
510(k) Number: K011699 Re: STO(K) Name: Vacuette® Blood Collection Tubes with Sodium Heparin Regulation Number: 862.1675 Regulatory Class: II Product Code: JKA Dated: May 31, 2001 Received: June 1, 2001
Dear Ms. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becally be o(x) = is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device meetstate conmistoc prov to that have been reclassified in accordance with the provisions of the Alliendiffens, of to devices man have occast . You may, therefore, market the device, subject to Tecteral Food, Drug, and Ocentent Fee et. The general controls provisions of the Act include the general controls provincils of the Fring 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 (Fremarket Approval), it they of backed f Federal Regulations, Title 21, Parts 800 to 895. allecting your device can of rounning assumes compliance with the Good Manufacturing in A Substantally equiralene acterimeral (GMP) regulation (21 CFR Part 820) and that, through Practice for Mearcal bonn the Food and Drug Administration (FDA) will verify such penodic offir inspections, alle i oow alle GMP regulation may result in regulatory action. In assumptions: Transle to configer announcements concerning your device in the Federal addition, PDA may Puonen rainer annovour premarket notification submission does not affect Register. Flease note: this response to your proam proam 542 of the Act for devices under the ally obligation you might in Control provisions, or other Federal laws or regulations.
2
Page 2
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 nothication. The FDA inding of successification 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 If you desire specific advice for your do revices), please contact the Office of Compliance at additionally 607.10 for m Prito diagnestions on the promotion and advertising of your device, (301) 594-4388. Additionally, for question of (101) 594-4639. Also, please note the regulation prease conact the Office or Compilance (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small illionnation on your responsionnes are use are momber (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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: VACUETTE® Blood Collection Tubes with sodium heparin
Indications For Use:
VACUETTE® tubes with sodium heparin are used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)