(55 days)
To collect, transport, separate and process capillary blood for testing serum in the clinical laboratory.
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.
This document describes the Greiner MiniCollect® Serum Gel tube, a blood collection device, and its substantial equivalence to a predicate device. The information provided heavily focuses on the regulatory submission and does not detail specific acceptance criteria or a dedicated study report with detailed performance metrics beyond a statement of "good correlation."
Here's an analysis based on the provided text, addressing your points where possible, and noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria (e.g., specific thresholds for correlation coefficients, bias, or agreement). Instead, it relies on demonstrating "good correlation" to the predicate device for assay results.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Equivalency of assay results to predicate device | "Test results from paired samples for 23 analytes and 13 hormones were evaluated demonstrating good correlation." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "paired samples" were used, but it does not specify the number of samples or patients included in this testing.
- Data Provenance: Not explicitly stated (e.g., country of origin). It's likely a retrospective or prospective study performed by the manufacturer, but this is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable in the typical sense for this type of device. The "ground truth" here is the performance of the predicate device (Becton Dickinson's Microtainer® Brand tubes with gel separator). The assay results are objective measurements from laboratory instruments, not subjective interpretations by experts.
4. Adjudication Method for the Test Set
Not applicable. There's no subjective assessment requiring adjudication. The comparison is based on quantitative assay results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is typically for imaging devices or diagnostics that involve human interpretation. This device is a blood collection tube, and its performance is evaluated by chemical analysis, not human reader interpretation. Therefore, no MRMC study or effect size for human reader improvement is relevant or mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. This device is a medical product (blood collection tube) and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth or reference standard for comparison was the assay results obtained from the predicate device, Becton Dickinson's Microtainer® Brand tubes with gel separator. The aim was to demonstrate that results from the Greiner MiniCollect® tubes correlate well with those from the established predicate device.
8. The Sample Size for the Training Set
This concept is not directly applicable. This is not an AI/ML device that requires a training set. The "evaluation" mentioned refers to the comparison of the new device's performance against a predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device with a training set.
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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 (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
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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 _________________________________________________________________________________________________________________________________________________________
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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 Laboratory Devices
510(k) Number. K982998
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.