(24 days)
Not Found
No
The 510(k) summary describes a blood collection tube and its intended use for coagulation testing. There is no mention of AI, ML, or any computational analysis of data that would suggest the use of these technologies. The device is a passive collection and transport device.
No
The device is a blood collection tube used for diagnostic testing (coagulation testing), not for treating a disease or condition.
No
The device is a blood collection tube used for coagulation testing, which is a step in the diagnostic process, but the tube itself does not perform the diagnosis. It collects, transports, and processes the sample.
No
The device is a physical blood collection tube containing a chemical solution, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for collecting, transporting, and processing whole blood for coagulation testing. Coagulation testing is a diagnostic procedure performed in vitro (outside the body) to assess blood clotting function.
- Device Description: The description reinforces its purpose as a blood collection device containing a substance (sodium citrate) used in the preparation of samples for diagnostic testing.
- Performance Studies: The summary of performance studies mentions evaluating assay results, which are the outcomes of diagnostic tests.
- Predicate Device: The predicate device is also a "Coagulation tube," further indicating the device's role in diagnostic testing.
The device is designed to prepare a sample (whole blood with anticoagulant) that will be used in a diagnostic test (coagulation assay). This fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The equivalence of assay results for both tubes (Greiner MiniCollect® Coagulation tubes and Greiner VACUETTE® Coagulation tubes) was evaluated by testing paired samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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).
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§ 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.
0
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/2 description: The image shows the word "Fax" in a bold, sans-serif font. To the left of the word "Fax" is a partial circle, which appears to be a stylized representation of a parenthesis or a similar curved shape. The overall design is simple and graphic, likely representing a logo or a symbol associated with fax machines or fax services.
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