GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE

K992244 · Greiner Meditech, Inc. · JKA · Jul 26, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992244
• Device Name: GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE
• Applicant: Greiner Meditech, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jul 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The MiniCollect® Coagulation tube is intended for citrate anticoagulated whole blood samples for Coagulation Assays.

Device Story

The Greiner MiniCollect® Coagulation tube is a non-sterile, non-evacuated plastic blood collection device containing a 3.2% sodium citrate solution. It is used to collect, transport, and process venous whole blood samples for coagulation assays. The device is intended for use by healthcare professionals in clinical settings. By providing a standardized environment for blood collection, it ensures the integrity of samples for subsequent laboratory coagulation testing, facilitating accurate clinical diagnosis and monitoring of coagulation-related conditions.

Clinical Evidence

Bench testing only. Equivalence was established by comparing assay results from paired blood samples collected in the subject MiniCollect® Coagulation tubes and the predicate VACUETTE® Coagulation tubes.

Technological Characteristics

Plastic blood collection tube containing 3.2% sodium citrate solution. Non-evacuated, non-sterile design.

Indications for Use

Indicated for the collection, transport, and processing of venous whole blood samples for coagulation testing.

Regulatory Classification

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.

Predicate Devices

• VACUETTE® Coagulation tube (K971221)

Submission Summary (Full Text)

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## JUL 26 1999

## K992244

## I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) pre-market notification for its Greiner MiniCollect® Coagulation tube with 3.2% sodium citrate solution for venous blood collection. The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a 3.2% sodium citrate solution, intended to collect, transport, and process whole blood for coagulation testing.

Greiner is claiming substantial equivalence to it's VACUETTE® Coagulation tube (K971221). Both blood collection tubes have intended use and are made out of plastic. The equivalence of assay results for both tubes was evaluated by testing paired samples collected in Greiner MiniCollect® Coagulation tubes and Greiner VACUETTE® Coagulation tubes.

Greiner's 510(k) has been submitted on July 1, 1999 by Doug Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, MD 21014 (410/836-8228).

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JUL 26 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Douglas L. Harris Managing Director Greiner Meditech, Inc. P.O. Box 943 Bel Air, Maryland 21014

K992244

Re:

Trade Name: MiniCollect® Coagulation Blood Collection Tube Regulatory Class: II Product Code: JKA Dated: July 2, 1999 Received: July 2, 1999

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 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 affecting your device can be found in the Code of Federal Regulations, 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 Regulation (QS) for Medical Devices: General regulation (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 regulation 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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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Image /page/3/Picture/3 description: The image shows the logo for Greiner Bio-One North America. The word "greiner" is in white text on a black rectangle. Below the rectangle, the words "VACUETTE" and "North America" are printed in black text.

| Urgent | For Review | Please Comment | Please Reply | Please Recycle | | |
|--------|------------------------------------|----------------|--------------|----------------|----------------------------------|--|
| Re: | Coag 510k responses | | | CC: | Helene Restrepo | |
| Phone: | [Click here and type phone number] | | | Date: | 07/13/99 | |
| Fax: | [Click here and type fax number] | | | Pages: | [Click here and type # of pages] | |
| To: | Alan Peacock | | | From: | Douglas L Harris | |

Alan our 510 number for the VACUETTE® ^Coag tube is

Indications for use

The MiniCollect® Coagulation tube is intended for citrate anticoagulated whole blood samples for Coagulation Assays.

Sean Cooper

(Division Sign-Off) ിvision of Clinical Laboratory Devices 10(k) Number_

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PRESCRIPTION USE 21 cer 801, 109