(28 days)
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No
The summary describes a blood collection device with anticoagulant and barrier material, focusing on its physical properties and performance in comparison to a predicate device. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a blood collection device for testing plasma/serum in a clinical laboratory. It is used for diagnostic purposes (collecting and processing blood for testing) and not for treating, preventing, or alleviating a disease or condition.
No
The device is intended to collect, transport, separate, and process capillary blood for testing plasma or serum, which are steps prior to diagnostic testing. It does not perform the testing or analysis itself.
No
The device description clearly states it is a physical blood collection device containing anticoagulant and barrier material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "To collect, transport, separate and process capillary blood for testing plasma in the clinical laboratory." This describes a process performed in vitro (outside the body) on a biological sample (blood) for the purpose of obtaining information for clinical diagnosis or monitoring.
- Device Description: The description details a device designed for collecting and processing blood, which is a key step in many in vitro diagnostic tests.
- Clinical Laboratory Setting: The intended user/care setting is the "clinical laboratory," which is where in vitro diagnostic testing is performed.
- Performance Studies: The performance studies describe evaluating the equivalency of assay results, which is a common practice for validating devices used in in vitro diagnostic testing.
- Predicate Device: The predicate device is another blood collection tube used for in vitro diagnostic testing.
All these factors strongly indicate that the Greiner MiniCollect® is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To collect, transport, separate and process capillary blood for testing plasma in the clinical laboratory.
Product codes
JKA
Device Description
The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing lithium heparin anticoagulant and an inert acrylic barrier material, intended to collect, transport, separate and process capillary blood for testing serum. 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.
Mentions image processing
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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
The equivalency of assay results for both tubes was evaluated by testing paired samples collected in Greiner MiniCollect® Lithium Heparin Gel tubes and Becton Dickinson Microtainer Brand tubes with lithium heparin and gel separator. Test results from paired samples for 22 analytes and 4 hormones were evaluated demonstrating good correlation.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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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® Lithium Heparin Gel tube with Lithium Heparin and separation gel for capillary blood collection. The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing lithium heparin anticoagulant 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 heparin 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® Lithium Heparin Gel tubes and Becton Dickinson Microtainer Brand tubes with lithium heparin and gel separator. Test results from paired samples for 22 analytes and 4 hormones were evaluated demonstrating good correlation.
Greiner's 510(k) has been submitted on May 28,1999 by Doug Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, MD 21014 (410/836-8228).
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이 이 지원 이상 이상 이상 이 대한민국 대학교 대학교 문학 역사 1992년 1992년 1992년 1992년 1992년 1992년 1992년 1992년 1992년 1992년 1992년 19
이후 기자 : 1
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 25 1999
Mr. Douglas L. Harris Managing Director Greiner Meditech, Inc. 260 Gateway Drive Suite 17A Bel Air, Maryland 21014
Re: K991843
Trade Name: MiniCollect® Lithium Heparin Gel Blood Collection Tube Regulatory Class: II Product Code: JKA Dated: May 28, 1999 Received: May 28, 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 Sutman
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): K991843
Device Name:
MiniCollect® Lithium Heparin Gel Blood Collection Tube
Indications for Use:
To collect, transport, separate and process capillary blood for testing plasma in the clinical laboratory.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 99 18 43
Prescription Use X
Over-The-Counter Use _