(24 days)
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.
The MiniCollect® Coagulation tube is intended for citrate anticoagulated whole blood samples for Coagulation Assays.
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.
The provided text is a 510(k) summary for the Greiner MiniCollect® Coagulation tube. It focuses on demonstrating substantial equivalence to a predicate device, the Greiner VACUETTE® Coagulation tube (K971221). The primary method of demonstrating this equivalence is through a comparative study of assay results using paired samples.
Here's an analysis of the provided information against your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Primary Goal: Substantial Equivalence to predicate device (Greiner VACUETTE® Coagulation tube). | "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." |
| Implied Performance: The study results supported the claim of substantial equivalence, as the device was cleared by the FDA. Specific numerical performance metrics (e.g., correlation coefficients, mean differences within acceptable ranges) are not provided in this summary. | |
| Intended Use: Collection, transport, and processing of whole blood for coagulation testing. | The device meets this intended use, as verified by the FDA's clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the number of paired samples used in the equivalence study. It only mentions "testing paired samples."
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of information is not relevant or typically provided for a device like a blood collection tube. The "ground truth" here is the assay results themselves, which are generated by laboratory instruments, not by expert interpretation.
4. Adjudication Method for the Test Set
Not applicable for this type of device and study. The comparison is between quantitative assay results, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this was not an MRMC comparative effectiveness study. This type of study is used to evaluate the impact of a device or algorithm on human reader performance, typically in diagnostic imaging. The Greiner MiniCollect® is a blood collection tube, and its evaluation focuses on analytical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense, the primary study was a "standalone" evaluation of the device's impact on assay results, independent of human interpretation or human-in-the-loop involvement during the device's operation (i.e., the tube itself doesn't have an algorithm). The performance being assessed is the analytical performance of the tube in preserving blood quality for coagulation testing.
7. The Type of Ground Truth Used
The ground truth was established by analytical results from standard coagulation assays performed on blood collected in the predicate device (Greiner VACUETTE® Coagulation tube). The paired samples allowed for a direct comparison of the tested device against an established, legally marketed standard.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or algorithms that require a "training set." The study evaluated the physical characteristics and chemical properties of the tube and its effect on blood samples.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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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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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of what appears to be a bird or abstract design composed of three curved lines.
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
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 (770) 488-7655.
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 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
§ 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.