(50 days)
To collect, transport, store, and evaluate capillary blood specimens for hematology and lead tests.
The Greiner MiniCollect® EDTA K3 tube is a non-sterile, non-evacuated blood collection device containing EDTA K3 anticoagulant additive, and is intended for use in evaluations of capillary blood specimens. The Greiner MiniCollect® tube 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.
The provided text is a 510(k) summary for a blood collection tube (Greiner MiniCollect® EDTA K3 tube) and does not describe an AI medical device. Therefore, much of the requested information, such as acceptance criteria for AI performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable.
However, I can extract the relevant information regarding the device's equivalency study.
Acceptance Criteria and Study for Greiner MiniCollect® EDTA K3 Blood Collection Tube
This device is a blood collection tube and not an AI medical device. The "acceptance criteria" in this context refers to demonstrating substantial equivalence to a legally marketed predicate device, rather than performance metrics for an AI algorithm. The study aimed to show that the new device yielded comparable assay results to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Equivalency of Assay Results | Good correlation between test results from paired samples for 15 hematology parameters and lead tests when collected in Greiner MiniCollect® EDTA K3 tubes and Becton Dickinson Microtainer® Brand EDTA K2 tubes. | "Test results from paired samples for 15 hematology parameters and lead tests were evaluated and good correlation was observed." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "paired samples" were used, but it does not specify the number of samples (n) involved in the study.
- Data Provenance: Not specified, but generally, such studies involve prospective collection of samples for comparison. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the study involved comparing assay results from two different blood collection tubes, not establishing ground truth for an AI algorithm's predictions. The "ground truth" here would be the actual values obtained from laboratory analysis, not expert consensus.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison of analytical results, not an assessment requiring expert adjudication.
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 is not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
The "ground truth" was the analytical results from standard laboratory assays for 15 hematology parameters and lead tests. These results were obtained from blood specimens collected in both the investigational device and the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI device, and therefore, no training set was used.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, this question is not relevant.
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OCT 19 1998
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I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) premarket notification for its Greiner MiniCollect® EDTA tube with EDTA K3 for capillary blood collection. The Greiner MiniCollect® EDTA K3 tube is a non-sterile, non-evacuated blood collection device containing EDTA K3 anticoagulant additive, and is intended for use in evaluations of capillary blood specimens.
Greiner is claiming substantial equivalence to Becton Dickinson's Microtainer® EDTA K > tube (K940905). Both blood collection tubes have intended use and are made out of the same material, polypropylene plastic. The Becton Dickinson Microtainer® EDTA tube uses EDTA K2 as an additive, while the Greiner MiniCollect® EDTA tube uses EDTA K3 as an additive. The Greiner MiniCollect® tube 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. The Becton Dickinson Microtainer® Brand EDTA tube caps are made of polyethylene. The equivalency of assay results for both tubes was evaluated by testing paired samples collected in Greiner MiniCollect® EDTA K3 tubes and Becton Dickinson Microtainer® Brand EDTA K2 tubes. Test results from paired samples for 15 hematology parameters and lead tests were evaluated and good correlation was observed.
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 16 1998
Douglas L. Harris . Manaqing Director Greiner Meditech, Inc. 260 Gateway Drive, Suite 17A P.O. Box 943 Bel Air, Maryland 21014
Re : K982999 MiniCollect® EDTA K, Blood Collection Tube Requlatory Class: II Product Code: JKA Dated: August 27, 1998 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 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 In addition, FDA may publish further announcements action. 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 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 Litman
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): ____________________________________________________________________________________________________________________________________________________
Device Name:
MiniCollect® EDTA K3 Blood Collection Tube
Indications for Use:
To collect, transport, store, and evaluate capillary blood specimens for hematology and lead tests.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 4982999
Prescription Use X 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.