VACUETTE EDTA K2 TUBES by GREINER VACUETTE NORTH AMERICA, INC.

The VACUETTE® EDTA K2 tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume. The VACUETTE® EDTA K2 tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.

Device Description

The VACUETTE® EDTA K2 Tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.

AI/ML Overview

The provided text describes the 510(k) summary for the VACUETTE® EDTA K2 Tubes. The core of the submission is to demonstrate substantial equivalence to a predicate device, the Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube, rather than meeting specific acceptance criteria defined by a standalone performance study in the way a diagnostic algorithm might. Therefore, the information typically requested for AI/algorithm performance (e.g., sample sizes for test/training, number of experts for ground truth, MRMC study details) is not directly applicable in its usual sense for this device.

However, I can extract the information related to the studies performed to demonstrate "substantial equivalence," interpreting the "acceptance criteria" as the comparable performance necessary to achieve substantial equivalence.

Here's the breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence study for a medical device (blood collection tube) rather than a diagnostic algorithm, the "acceptance criteria" are framed as demonstrating performance comparable to the predicate device in specific applications, particularly molecular diagnostic assays. The "reported device performance" shows that the VACUETTE® EDTA K2 Tube achieved this comparable performance.

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate)	Reported Device Performance (VACUETTE® EDTA K2 Tubes)
Similar sensitivity and recovery at lower detection limits for HIV PCR.	Demonstrated similar sensitivity and recovery at the lower detection limits for HIV quantitation.
Similar sensitivity and recovery at lower detection limits for HCV PCR.	Demonstrated similar sensitivity and recovery at the lower detection limits for HCV quantitation.
Substantially equivalent results in HIV quantitation.	Demonstrated substantially equivalent results in HIV quantitation.
Substantially equivalent results in HCV quantitation.	Demonstrated substantially equivalent results in HCV quantitation.
No significant effect on HIV results when plasma is separated from blood cells within 24 hours.	No effect was seen when plasma collected from the Greiner tube was separated from blood cells within 24 hours for HIV.
No significant effect on HCV results when plasma is separated from blood cells within 2 hours.	No effect was seen when plasma collected from the Greiner tube was separated from blood cells within 2 hours for HCV.
No difference in HIV results for fresh vs. once frozen samples.	No difference in HIV results within or between the two tube types for fresh versus once frozen samples.
No difference in HIV results when plasma samples are exposed to 5 freeze/thaw cycles.	No difference in HIV results when plasma samples were exposed to 5 freeze/thaw cycles.
No difference in HCV results for fresh vs. once frozen samples.	No difference in HCV results within or between the two tube types for fresh versus once frozen samples.
No difference in HCV results when plasma samples are exposed to 5 freeze/thaw cycles.	No difference in HCV results when plasma samples were exposed to 5 freeze/thaw cycles.

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

The document does not explicitly state the specific number of samples or subjects used in these validation studies. It describes the types of studies conducted:

Limited validation testing on HIV and HCV PCR assays using WHO standards at lower detection limits.
Comparison of HIV and HCV lower detection limits using both types of tubes.
Comparison of HIV and HCV recovery using both types of tubes.
Equivalency studies of Greiner and BD tubes with regard to results of HIV and HCV PCR testing.
Evaluation of effects of delay in separation of plasma and blood cells on HIV and HCV results.
Determination of equivalency of HIV and HCV results from fresh and multiple freeze-thaw samples.

The data provenance (country of origin, retrospective/prospective) is not specified in the summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable and is not provided in the document. The "ground truth" in this context would be the actual concentration or presence of HIV/HCV in the samples, determined by established molecular diagnostic assays, not by expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided. The performance assessment is based on quantitative PCR results, which do not typically involve human adjudication in the described manner.

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

This information is not applicable. The device is a blood collection tube, not an AI or imaging diagnostic tool. An MRMC study is therefore not relevant.

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

This information is not applicable. The device is a physical product (blood collection tube) and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies was the quantitation of HIV and HCV using PCR assays, likely against established reference standards (e.g., WHO standards for lower detection limits). This is a form of laboratory assay result or reference standard comparison.

8. The Sample Size for the Training Set

This concept is not applicable as this is not an AI/machine learning device. The studies described are validation and equivalence studies, not training of an algorithm.

9. How the Ground Truth for the Training Set was Established

This concept is not applicable for the reason stated above. The "ground truth" (HIV/HCV quantitation) was established by standard laboratory procedures and reference materials.

Summary

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510(k) SUMMARY

December 11, 2001

CONTACT:

Douglas L. Harris Greiner Vacuette North America, Inc. P.O Box 1026 Monroe, NC 28111

K014104

NAME OF DEVICE: Trade Name: Common Names/Descriptions: Classification Name:

Vacuette® EDTA K2 Tubes Evacuated Blood Collection System Tubes, Vials, Systems, Serum Separators, Blood Collection

PREDICATE DEVICE:

Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube (K972075)

DEVICE DESCRIPTION:

INTENDED USE: The VACUETTE® EDTA K2 tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume.

PRODUCT DESCRIPTION._The VACUETTE® EDTA K2 Tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.

SUBSTANTIAL EQUIVALENCE:

The VACUETTE® EDTA K2 Tube and the Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube are substantially equivalent in intended use, design and composition.

Studies were conducted to demonstrate substantial equivalence of the Greiner VACUETTE® EDTA K2 Tube to the Becton Dickinson (BD) Vacutainer® Brand PPT™ Plasma Preparation Tube when samples from these tubes are used in PCR assays.

The substantial equivalence studies included:

Limited validation testing on the HIV and HCV PCR assays using WHO standards at the lower ● detection limits; comparison of HIV and HCV lower detection limits using both types of tubes;
Comparison of HIV and HCV recovery using both types of tubes; .
Equivalency studies of Greiner and BD tubes with regard to results of HIV and HCV PCR . testing;
Evaluation of effects of delay in separation of plasma and blood cells on HIV and HCV results . using both types of tubes;
Determination of equivalency of HIV and HCV results from fresh and multiple freezedthaw . samples collected in the two tube types.

The conclusions from the study were:

Both tubes demonstrated similar sensitivity and recovery at the lower detection limits for both . HIV and HCV quantitation;
Both tubes demonstrated substantially equivalent results in HIV and HCV quantitation;
No effect was seen when plasma collected from the Greiner tube was separated from blood ● cells within 24 hours for HIV or within 2 hours for HCV;
There was no difference in HIV or HCV results within or between the two tube types for fresh versus once frozen samples or when plasma samples were exposed to 5 freeze/thaw cycles for HIV or HCV.

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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 lines representing its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Sienna Partners, L.L.C. Judi Smith Principal P. O. Box 103 Baldwin, MD 21013

FEB 0 6 2015

Re: K014104

Trade/Device Name: Vacuette EDTA K2 Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: PJE Dated: December 11, 2001 Received: December 13, 2001

Dear Ms. Smith:

This letter corrects our substantially equivalent letter of February 1, 2002. -

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809]), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kall Sumo

for: Cou
Direc

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

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510(k) Number (if known): 折〇八十八〇Ч

Device Name: VACUETTE® EDTA K2 Tubes

Indications For Use: The VACUETTE® EDTA K2 tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume. The VACUETTE® EDTA K2 tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.

Can Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KC14104

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.