(162 days)
VACUETTE® Blood Collection Tubes with Clot Activator, Gel Separator, and Standard Stopper (16 x 100 mm, 8 mL) are used to collect, transport and process blood for testing serum in the clinical laboratory. In addition, the tubes are suitable for therapeutic drug monitoring (TDM).
Greiner VACUETTE® Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8 mL)
This document is an FDA 510(k) clearance letter for a blood collection tube. It does not contain information about the acceptance criteria or a study proving a device meets acceptance criteria in the context of an AI-powered medical device.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 5 - 2009
Greiner Bio-One North America c/o Ms. Judi Smith Application Correspondent P.O. Box 103 Baldwin, MD 21013
K081929 Re:
Trade/Device Name: Greiner Vacuette® Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8 mL) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device. Regulatory Class: Class II Product Code: JKA Dated: November 24, 2008 Received: November 26, 2008
Dear Ms. Smith:
This letter corrects our substantially equivalent letter of December 16, 2009.
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 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 (QS) regulation (21 CFR Part 820).
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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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Coopes, M.S., D.V.M.
Yean M. Cooper, M.S., 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
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Indication for Use
510(k) Number (if known): K081929
Device Name: Greiner VACUETTE® Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8 mL)
Indication For Use:
VACUETTE® Blood Collection Tubes with Clot Activator, Gel Separator, and Standard Stopper (16 x 100 mm, 8 mL) are used to collect, transport and process blood for testing serum in the clinical laboratory. In addition, the tubes are suitable for therapeutic drug monitoring (TDM).
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081929
§ 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.