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

The VACUETTE® EDTA K2 Gel 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, and a gel barrier material. The VACUETTE® EDTA K2 Gel 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 Gel 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Greiner VACUETTE® EDTA K2 Gel Tubes:

This 510(k) summary is for a medical device (blood collection tube) and focuses on demonstrating substantial equivalence to an existing predicate device rather than meeting specific performance criteria against predefined numerical targets. Therefore, the "acceptance criteria" are implied by the performance of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate)	Reported Device Performance (VACUETTE® EDTA K2 Gel Tubes)
Similar sensitivity and recovery at lower detection limits for HIV and HCV quantitation.	Demonstrated similar sensitivity and recovery at the lower detection limits for both HIV and HCV quantitation.
Substantially equivalent results in HIV and HCV quantitation.	Demonstrated substantially equivalent results in HIV and HCV quantitation.
No significant effect of plasma separation delay (within 24 hours) on HIV or HCV results.	No effect was seen when plasma collected from the Greiner tube was separated from blood cells within 24 hours for HIV or HCV.
No significant difference in HIV or HCV results between fresh vs. once-frozen samples or specific freeze/thaw cycles.	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 1 freeze/thaw cycle for HCV. (This implies performance comparable to the predicate for these conditions).

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

Sample Size: The document does not specify the exact sample size (number of patient samples or replicates) used for the tests. It only mentions "samples from these tubes" which were used in PCR assays.
Data Provenance: Not explicitly stated, but the mention of "WHO standards" suggests an international or standardized approach. The study was conducted by Greiner Vacuette North America, Inc. It's likely these were prospective studies conducted for the purpose of this submission, but it's not explicitly labeled as "prospective" or "retrospective."
Country of Origin: Not specified.

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

Number of Experts: This information is not provided.
Qualifications of Experts: This information is not provided.
- Note: Given the nature of a blood collection device study focused on PCR assay performance, ground truth would likely be established by lab technicians/scientists following validated PCR protocols, rather than medical experts in the traditional sense (e.g., radiologists). The "ground truth" here is the accurate quantification of HIV and HCV using established PCR methods.

4. Adjudication Method for the Test Set

Adjudication Method: This information is not provided. Adjudication as typically understood in image analysis (e.g., 2+1) is not applicable to this type of laboratory-based quantitative comparison. The "adjudication" would be inherent in the standard laboratory protocols and quality control measures for PCR assays.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that rely on human interpretation (e.g., radiology AI). This device is a blood collection tube, and the "effectiveness" is measured by the performance of subsequent analytical assays (PCR), not human reader performance.
Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Yes, in essence, the study conducted represents a "standalone" evaluation of the device's impact on the sample. The performance is assessed directly through laboratory assays (PCR) using samples collected in the device, without an "human-in-the-loop" interpretation step that would involve a human user's decision-making in the context of the device's output. The device itself (the tube) doesn't have an "algorithm" in the conventional sense, but its physical and chemical properties are tested in isolation regarding their effect on sample integrity for PCR.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth is the quantification of HIV and HCV RNA/DNA using established PCR assay methods, validated by "WHO standards" at lower detection limits. The "truth" is the accurate and consistent measurement of these viral loads. The comparison is made against the performance of the predicate device under the same conditions.

8. Sample Size for the Training Set

Sample Size for Training Set: This information is not provided. For a medical device like a blood collection tube, there isn't typically a "training set" in the machine learning sense. The device itself isn't "trained." If any initial development or optimization involved testing, the details are not included in this summary. The studies described are validation studies for the final product.

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

Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the machine learning context for this device. The rigorous laboratory testing and comparison to WHO standards would serve as the basis for understanding and demonstrating the performance characteristics of the VACUETTE® EDTA K2 Gel Tubes.

Summary

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K0/2043

June 27, 2001

510(k) Summary

CONTACT:

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

NAME OF DEVICES:
Trade Name:	Vacuette® EDTA K2 Gel Tubes
Common Names/Descriptions:	Evacuated Blood Collection System
Classification Name:	Tubes, Vials, Systems, Serum Separators, BloodCollection

PREDICATE DEVICE:

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

DEVICE DESCRIPTION:

INTENDED USE: The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated svstem. 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, and a gel barrier material.

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

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

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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 once . frozen samples collected in the two tube types;
Determination of equivalency of HIV and HCV results from fresh and . multiple freeze/thaw samples using both types of tubes.

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 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 1 freeze/thaw cycle for HCV.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the seal's perimeter. The seal is black and white.

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

Greiner Bio-One North America, Inc. C/o Ms. Judi Smith Sienna Partners, L.L.C. Principal P. O. Box 103 Baldwin, MD 21013

FEB 0 6 2015

Re: K012043

Trade/Device Name: Vacuette EDTA K2 Gel Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: PJE Dated: August 28, 2001 Received: August 30, 2001

Dear Ms. Smith:

This letter corrects our substantially equivalent letter of September 24, 2001.

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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CFR Part 807): labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Rall Davis

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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Page 1 of 1

510(k) Number (if known): KO lacu 3

Device Name: VACUETTE® EDTA K2 Gel Tubes

Indications For Use: The VACUETTE® EDTA K2 Gel tube provides a means for collection, indications of over in 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 oyetsm. The tabe containt opray to its fill volume, and a gel barrier material. The VACUETTE® EDTA K2 Gel 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kesia Alexander for Jean Cooper

vision of Clinica 510(k) Number

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.