(50 days)
No
The 510(k) summary describes a blood collection tube and its performance in PCR assays. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a tube for collecting and processing blood specimens for diagnostic testing, not for treating any condition or disease.
No
Explanation: The device is a sample collection and processing tube, specifically for preparing plasma for use in "molecular diagnostic test methods." It is a component used in diagnostic testing but is not itself a diagnostic device that performs a diagnosis.
No
The device description clearly states it is a plastic tube for collecting venous blood, which is a physical hardware component.
Based on the provided information, the VACUETTE® EDTA K2 tube is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the 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." This clearly indicates that the collected and processed specimen is intended for use in diagnostic tests performed in vitro (outside the body).
- Device Description: The device description reiterates the use of the tube 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) for use in HIV and HCV PCR assays, which are diagnostic tests. The metrics evaluated (sensitivity and recovery at lower detection limits) are relevant to the performance of a device used in diagnostic procedures.
While the device itself is a collection and processing tube, its intended use is directly linked to providing a specimen suitable for in vitro diagnostic testing. This makes it an IVD device.
N/A
Intended Use / 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.
Product codes
PJE
Device Description
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
510(k) SUMMARY
December 11, 2001
CONTACT:
Douglas L. Harris Greiner Vacuette North America, Inc. P.O Box 1026 Monroe, NC 28111
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.
1
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
2
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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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)