(53 days)
Not Found
No
The description focuses on the physical components and function of a blood collection tube, with no mention of AI or ML.
No.
This device is designed for collecting, transporting, storing, and processing blood for testing serum in a clinical laboratory and for therapeutic drug monitoring, not for delivering therapy.
No
This device is a blood collection tube used for processing blood samples in a laboratory. It is a tool for collecting and preparing samples, not for directly diagnosing a condition.
No
The device description clearly states it is a physical blood collection tube containing a clot activator and gel separator, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "To collect, transport, store and process blood for testing serum in the clinical laboratory." This clearly indicates the device is used in vitro (outside the body) for diagnostic purposes (testing serum).
- Device Description: The description details a "blood collection device" used for processing blood, which aligns with the function of an IVD used in laboratory testing.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is the typical setting for performing in vitro diagnostic tests.
The information provided strongly supports the classification of this device as an IVD.
N/A
Intended Use / Indications for Use
To collect, transport, store and process blood for testing serum in the clinical laboratory. In addition, tubes are suitable for therapeutic drug monitoring.
Product codes
JKA
Device Description
The Greiner VACUETTE® blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator and an inert polymeric barrier material.
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 tests show that there is no significant clinical difference between Greiner VACUETTE® blood collection tubes with clot activator and gel separator and Becton Dickinson plain glass blood collection tubes. Clinical tests compared Greiner VACUETTE® blood collection tubes with clot activator and no gel separator, and VACUETTE® blood collection tubes with clot activator and gel separator to Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes. No clinically significant difference was noted in these comparison studies.
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.
K960858, Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes
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.
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DEC 28 1998
1983952
I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Greiner Meditech. Inc. ("Greiner") is submitting a labeling change to its already approved VACUETTE® blood collection tube with clot activator and gel separator (K960858). The Greiner VACUETTE® blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator and an inert polymeric barrier material. The product is intended for use in collecting, transporting, storing and processing blood serum from cellular components of blood. The labeling change is to exclude the existing contraindication on labeling of the VACUETTE® Blood Collection tube with clot activator and gel separator for use of the tube in therapeutic drug monitoring, and to include on the labeling a statement that the tubes are suitable for such use.
Greiner is claiming substantial equivalence to its previously cleared VACUETTE® blood collection tube with clot activator and gel separator (K960858) and to Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes. The modified blood collection tubes still will have the same basic intended use as the cleared VACUETTE® tube, with the additional use for therapeutic drug monitoring. The plastic tube material, clot activator and gel separator material will remain the same as in the cleared VACUETTE® tube (K960858). Clinical tests show that there is no significant clinical difference between Greiner VACUETTE® blood collection tubes with clot activator and gel separator and Becton Dickinson plain glass blood collection tubes. Clinical tests compared Greiner VACUETTE® blood collection tubes with clot activator and no gel separator, and VACUETTE® blood collection tubes with clot activator and gel separator to Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes. No clinically significant difference was noted in these comparison studies.
Greiner's 510(k) has been submitted on November 2, 1998 by Doug Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, MD 21014 (410) 836-8228.
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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three overlapping lines that resemble a person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
DEC 28 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Douglas L. Harris Managing Director Greiner Meditech, Inc. P.O. Box 943 Bel Air, MD 21014
Re: K983952 Trade Name: VACUETTE® Blood Collection Tube w/ Clot Activator and Gel Separator Regulatory Class: II Product Code: JKA November 5, 1998 Dated: Received: November 5, 1998
Dear Mr. Harris:
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 aqainst 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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 requlation 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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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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
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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P.O. Box 943 Bel Air, Maryland 21014
510(k) Number (if known): K983952
Device Name: VACUETTE® Blood Collection Tube with Clot Activator and Gel Separator
Indications For Use: To collect, transport, store and process blood for testing serum in the clinical laboratory. In addition, tubes are suitable for therapeutic drug monitoring.
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(Division Sign-Off) Division of Clinical Laboratory Devices 1983957 510(k) Number _
Prescription Use X
Over-the-Counter Use _