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.

AI/ML Overview

The provided text describes a 510(k) summary for the Greiner MiniCollect® Lithium Heparin Gel tube. The study focuses on demonstrating substantial equivalence to a predicate device, not on specific acceptance criteria for a new clinical performance claim. Therefore, the requested information about acceptance criteria for a device, MRMC studies, ground truth establishment, and training set details are not fully applicable or available in the provided text.

However, based on the provided text, here's an attempt to extract relevant information and note what is not applicable or provided:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (Becton Dickinson's Microtainer® Brand heparin tubes with gel separator).	"Test results from paired samples for 22 analytes and 4 hormones were evaluated demonstrating good correlation." The formal acceptance criteria for "good correlation" are not explicitly stated (e.g., specific correlation coefficient thresholds).
Same intended use as the predicate device.	The Greiner MiniCollect® is intended "to collect, transport, separate and process capillary blood for testing serum," which is the same intended use as the predicate.
Made of the same material as the predicate device.	Both tubes are made of "polypropylene plastic."

2. Sample size used for the test set and the data provenance

Sample Size: "paired samples for 22 analytes and 4 hormones" were evaluated. The exact number of patients or individual samples is not specified, but it implies multiple samples for each of the 26 assessed parameters.
Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/provided. The study compared the performance of two blood collection tubes rather than relying on expert interpretation for a "ground truth" diagnosis. The "ground truth" for the analytes/hormones would be established by standard assay methods, which are inherently part of the test.

4. Adjudication method for the test set

Not applicable/provided. There was no expert adjudication process described as the study compared analytical results from two devices.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a blood collection tube, not an AI-powered diagnostic system involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a blood collection tube, not an AI algorithm. The performance evaluation was based on analytical results of blood collected in the tubes.

7. The type of ground truth used

The "ground truth" in this context refers to the analytical results obtained from the predicate device, Becton Dickinson's Microtainer® Brand heparin tubes with gel separator. The study aimed to show that the new device yielded comparable analytical results. The "ground truth" for the analytes themselves would be the accuracy and precision of the respective laboratory assays.

8. The sample size for the training set

Not applicable. This study does not involve a training set as it's a comparison of two physical medical devices, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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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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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 _

Regulation Number and Section

§ 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.