GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE

K982998 · Greiner Meditech, Inc. · JKA · Oct 21, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982998
• Device Name: GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE
• Applicant: Greiner Meditech, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

To collect, transport, separate and process capillary blood for testing serum in the clinical laboratory.

Device Story

MiniCollect® Serum Gel tube is a non-sterile, non-evacuated capillary blood collection device. It contains a clot activator and an inert acrylic barrier material to facilitate serum separation. The device features a rubber cap with cross-cuts, allowing direct collection and sampling without cap removal. Used by healthcare professionals in clinical settings to process capillary blood samples for serum analysis. The device enables efficient blood collection and separation, ensuring sample integrity for subsequent laboratory testing.

Clinical Evidence

Bench testing only. Equivalence was evaluated by testing paired samples collected in Greiner MiniCollect® Serum Gel tubes and Becton Dickinson Microtainer® Brand tubes. Results for 23 analytes and 13 hormones demonstrated good correlation between the two devices.

Technological Characteristics

Materials: Polypropylene plastic tube, rubber cap with cross-cuts. Contains clot activator and inert acrylic barrier material. Non-sterile, non-evacuated design.

Indications for Use

Indicated for the collection, transport, separation, and processing of capillary blood for serum testing in clinical laboratory settings.

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

• Becton Dickinson's Microtainer® Brand tubes with gel separator

Submission Summary (Full Text)

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

Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) pre-market notification for its Greiner MiniCollect® Serum Gel tube with clot activator and separation gel for capillary blood collection. The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a clot activator and an inert acrylic barrier material, intended to collect, transport, separate and process capillary blood for testing serum.

Greiner is claiming substantial equivalence to Becton Dickinson's Microtainer® Brand tubes with gel separator. Both blood collection tubes have the same intended use and are made out of the same material, polypropylene plastic. The Greiner MiniCollect® cap is made from rubber and has "cross-cuts" to allow for direct collection into and sampling from the tube without having to remove the cap. Becton Dickinson's Microtainer® Brand tube caps are polypropylene stoppers. The equivalency of assay results for both tubes was evaluated by testing paired samples collected in Greiner MiniCollect® Serum Gel tubes and Becton Dickinson Microtainer® Brand tubes with gel separator. Test results from paired samples for 23 analytes and 13 hormones were evaluated demonstrating good correlation.

Greiner's 510(k) has been submitted on August 27, 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 U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 21 1998

Douqlas L. Harris .Managing Director Greiner Meditech, Inc. 260 Gateway Drive, Suite 17A P.O. Box 943 Bel Air, Maryland 21014

Re : K982998 MiniCollect® Serum Gel Blood Collection Tube Regulatory Class: II Product Code: JKA August 27, 1998 Dated: Received: August 27, 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 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 requlations 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 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 Reqister. 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 requlations.

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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 requlation (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/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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## STATEMENT OF INDICATIONS FOR USE

| 510(k) Number (if known): | K982998 |
|---------------------------|-----------------------------------------------------------------------------------------------------------|
| Device Name: | MiniCollect® Serum Gel Blood Collection Tube |
| Indications for Use: | To collect, transport, separate and process capillary blood for testing serum in the clinical laboratory. |

(Division Sign-Off)
Division of Clinical Laboral Devices
510(k) Number. K982998

Prescription Use _____________________________________________________________________________________________________________________________________________________________

ﮧ

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

{4}------------------------------------------------

## STATEMENT OF INDICATIONS FOR USE

| 510(k) Number (if known): | K982998 |
|---------------------------|-----------------------------------------------------------------------------------------------------------|
| Device Name: | MiniCollect® Serum Gel Blood Collection Tube |
| Indications for Use: | To collect, transport, separate and process capillary blood for testing serum in the clinical laboratory. |

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K982998

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________