(87 days)
No
The summary describes a blood collection tube and its performance in PCR assays, with no mention of AI or ML technologies.
No.
This device is used for the collection, processing, and transportation of blood samples for diagnostic testing, not for treating any disease or condition.
No
The device is a blood collection tube used for plasma preparation, which is a pre-analytical step for diagnostic tests. It does not perform the diagnostic test itself.
No
The device is a physical blood collection tube containing chemical components (EDTA and gel barrier) and is used for processing and transporting blood specimens. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the collected and processed plasma is 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." This directly links the device to diagnostic testing.
- Device Description: The description reiterates that the tube is used for plasma preparation for use in "molecular diagnostic test methods."
- Performance Studies: The performance studies compare the device to a predicate device (Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube) specifically in the context of HIV and HCV PCR assays, which are diagnostic tests. The studies evaluate metrics like sensitivity and recovery in relation to these diagnostic tests.
The device is a specimen collection and preparation device intended to be used with diagnostic tests, making it an IVD accessory or component.
N/A
Intended Use / Indications for Use
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.
Product codes
PJE
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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, Blood |
| Collection |
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.
1
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.
2
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
3
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)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)