Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes are designed for the collection, transportation and processing of capillary blood (collected via lancet stick) whenever a small amount of blood is preferred.

Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are used to obtain whole blood for testing parameters in hematology.

Device Description

Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA are non-evacuated, non-sterile, low sample volume tubes made from virtually unbreakable, highly transparent polypropylene. The tube measures 11 x 40 mm and there is a predefined nominal fill volume of 0.5 mL for achieving correct additive concentrations.

AI/ML Overview

The provided 510(k) summary for K063357 (Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA)) mentions a study conducted to demonstrate substantial equivalence, but it does not provide specific acceptance criteria or detailed results in the format requested.

The summary states: "A study was conducted to demonstrate substantial equivalence of the Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA with the Greiner Bio-One VACUETTE® Blood Collection Tube with K2EDTA (K014104) and the Becton Dickinson Microtainer® Tube with K2EDTA (K940905) when samples from these tubes are used in hematology assays."

And the conclusion: "The conclusion from the study is that the hematology results from samples collected in the Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are substantially equivalent to those collected in the predicate tubes."

This indicates that the study aimed to show that key hematology parameters measured from blood collected in the new device were comparable to those from predicate devices. However, the exact metrics for "substantial equivalence" (e.g., specific ranges for acceptable differences in cell counts, hemoglobin, etc.) are not detailed in this document.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not Specified	"hematology results from samples collected in the Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are substantially equivalent to those collected in the predicate tubes."

Note: The document states that the conclusion of the study was substantial equivalence. It does not provide the specific numerical acceptance criteria (e.g., "difference in WBC count must be within +/- X%") or the actual numerical results obtained for each hematological parameter for a direct comparison.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The study was "conducted," implying it was likely prospective, but this is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This study is a performance comparison of blood collection tubes for hematology assays, not an AI device requiring expert ground truth for interpretation. The "ground truth" would be the measurements obtained from the predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. This study is a performance comparison of blood collection tubes for hematology assays, not an AI device requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is not an MRMC study. It is a study comparing the performance of a medical device (blood collection tube) against predicate devices for analytical performance in hematology assays.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This is a physical medical device (blood collection tube), not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this study would be the hematology assay results obtained from samples collected in the predicate devices. The new device's performance is compared against these established results.

8. Sample Size for the Training Set:

Not applicable. This is a performance study for a physical device, not an AI/machine learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established:

Not applicable. As above, no training set for an AI model.

Summary

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K063357

510(k) SUMMARY

JUL 1 0 2007 November 3, 2006

CONTACT: Douglas L. Harris Greiner Vacuette North America, Inc. 4238 Capital Drive Monroe, NC 28110

NAME OF DEVICE: Greiner Bio-One MiniCollect® Capillary Blood Collection Trade Name: Tubes with dipotassium EDTA (K2EDTA) Common Names/Descriptions: Blood Collection System Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection VACUETTE® PREDICATE DEVICES: Greiner Bio-One Evacuated Blood Collection Tube with K2EDTA (K014104); Becton Dickinson Microtainer® Tube with K2 EDTA (K940905)

DEVICE DESCRIPTION:

Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA are nonevacuated, non-sterile, low sample volume tubes made from virtually unbreakable, highly transparent polypropylene. The tube measures 11 x 40 mm and there is a predefined nominal fill volume of 0.5 mL for achieving correct additive concentrations.

INTENDED USE:

Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are used to obtain whole blood for testing parameters in hematology.

SUBSTANTIAL EQUIVALENCE:

Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA are substantially equivalent to the Greiner Bio-One VACUETTE® Blood Collection Tube with K2EDTA (K014104) and the Becton Dickinson Microtainer® Tube with K2EDTA (K940905) in intended use, design and composition.

A study was conducted to demonstrate substantial equivalence of theGreiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA with the Greiner Bio-One VACUETTE® Blood Collection Tube with K2EDTA (K014104) and the Becton Dickinson Microtainer® Tube with K2EDTA (K940905) when samples from these tubes are used in hematology assays.

The conclusion from the study is that the hematology results from samples collected in the Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are substantially equivalent to those collected in the predicate tubes.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 0 2007

Douglas L. Harris Greiner Vacuette North America, Inc. 4238 Capital Drive Monroe, North Carolina 28110

Re: K063357

. Trade/Device Name: Greiner Bio-One MiniCollect Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Collection System Regulatory Class: Class II Product Code: JKA Dated: June 13, 2007 Received: June 15, 2007

Dear Mr. Harris:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

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Page 2 – Douglas L. Harris

will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert H. Becker

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology

Office of In Vitro Diagnostic Device Evaluation and Safety

Center for Devices and Radiological Health

Enclosure

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Page 3 – Douglas L. Harris

cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ- Division D.O.

and the comments of the comments of

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Indications for Use

510(k) Number (if known): K063357

Device Name: Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA)

Indications for Use:

Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are used to obtain whole blood for testing parameters in hematology.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Josephine Bautista
Division Sign Off

Office of In Vitro Diagn

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K063357

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.