(55 days)
Not Found
Not Found
No
The description focuses on a physical blood collection device and its components, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is intended for collecting, transporting, separating, and processing blood samples for in vitro diagnostic testing, not for treating a disease or condition.
No
Explanation: The device is a blood collection and processing device, not one that directly diagnoses a medical condition. It prepares samples for diagnostic testing, but does not perform the diagnosis itself.
No
The device description clearly states it is a "non-sterile, non-evacuated blood collection device containing a clot activator and an inert acrylic barrier material," which are physical components, 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 serum 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 to handle and process blood for testing, which aligns with the function of an IVD.
- Clinical Laboratory Setting: The intended user/care setting is the "clinical laboratory," which is where IVD testing is performed.
- Performance Studies: The performance studies describe the evaluation of assay results from samples processed by the device, comparing them to a predicate device used for the same purpose. This is typical for demonstrating the performance of an IVD.
The core function of collecting, processing, and preparing a biological sample for subsequent testing in a clinical laboratory is a defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
To collect, transport, separate and process capillary blood for testing serum in the clinical laboratory.
Product codes
JKA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
1982998
4
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).
1
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.
2
Page 2
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 requlation (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/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
3
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 _________________________________________________________________________________________________________________________________________________________