VACUETTE EDTA K2 TUBES

K014104 · Greiner Vacuette North America, Inc. · PJE · Feb 1, 2002 · Clinical Chemistry

Device Facts

• Record ID: K014104
• Device Name: VACUETTE EDTA K2 TUBES
• Applicant: Greiner Vacuette North America, Inc.
• Product Code: PJE · Clinical Chemistry
• Decision Date: Feb 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

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. 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 Story

Plastic evacuated tube containing spray-dried EDTA; collects venous blood; centrifugation separates undiluted plasma; used in clinical laboratory settings; facilitates molecular diagnostic testing (e.g., PCR); ensures specimen integrity for transport and processing; enables accurate quantification of analytes like HIV and HCV; benefits patient by providing reliable plasma samples for diagnostic assays.

Clinical Evidence

Bench testing only. Comparative study of Greiner and BD tubes using HIV and HCV PCR assays. Evaluated sensitivity, recovery, and lower detection limits using WHO standards. Assessed effects of delayed plasma separation (up to 24h for HIV, 2h for HCV) and freeze-thaw stability (5 cycles). Results showed equivalent performance between tube types.

Technological Characteristics

Plastic evacuated tube; spray-dried EDTA additive (1.8mg/mL ratio); closed system; centrifugation-based separation.

Indications for Use

Indicated for collection, processing, and transport of venous blood to obtain undiluted plasma for molecular diagnostic testing (e.g., PCR) or other laboratory procedures requiring undiluted plasma.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)