(175 days)
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No
The summary describes a blood collection system and its performance in molecular diagnostic assays, with no mention of AI or ML.
No
The device is used for the collection and processing of blood for diagnostic testing, not for therapeutic intervention.
No
The device is used for the collection, transport, and processing of blood for testing, including in molecular diagnostics. It is a sample collection and preparation device, not a diagnostic device itself.
No
The device description clearly states it is a system of tubes, holders, and needles for blood collection, which are physical hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the VACUETTE® system is used for the collection of venous blood for testing in the clinical laboratory, and specifically mentions the use of VACUETTE® EDTA K3 Tubes for testing plasma and whole blood in molecular diagnostics. This aligns with the definition of an IVD, which is a device intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description reinforces the intended use by stating the tubes are used to "collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory."
- Performance Studies: The document describes performance studies comparing the device to predicate devices for use in molecular diagnostic (nucleic acid PCR) assays, which are IVD tests.
- Predicate Devices: The predicate devices listed are also IVD devices (blood collection tubes used for testing).
While the document doesn't explicitly use the term "IVD" in the intended use statement, the function and purpose of the device as described clearly fall under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® tubes are used to collect, byten for and process blood for testing serum, plasma or whole blood in the clinical transport and process & EDTA K3 Tubes are used for testing whole blood in molecular diagnostics.
VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® EDTA K3 Tubes are used for testing plasma in molecular diagnostics. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.
Product codes (comma separated list FDA assigned to the subject device)
PJE
Device Description
INTENDED USE: VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® tubes are used to collect, byten for and process blood for testing serum, plasma or whole blood in the clinical transport and process & EDTA K3 Tubes are used for testing whole blood in molecular diagnostics.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies were conducted to demonstrate substantial equivalence of the Greiner Studies were conducted to demonet. Becton Dickinson (BD) Vacutainer® Brand PPT™ Plasma Preparation Tube and Glass K3 EDTA Tube when samples from these tubes are used in molecular diagnostic (nucleic acid PCR) assays.
The conclusion from the studies were that the HIV-1 and HCV PCR results from the The contractly healthy blood donors' and patients' samples collected in the Greiner and BD tubes were substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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K 042927
October 21, 2004
510(k) SUMMARY
CONTACT:
Douglas L. Harris Greiner Vacuette North America, Inc. P.O Box 1026 Monroe. NC 28111
NAME OF DEVICE:
| Trade Name: | Vacuette® EDTA K3 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) and Glass K3 EDTA Tube (pre-amendment)
DEVICE DESCRIPTION:
INTENDED USE: VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® tubes are used to collect, byten for and process blood for testing serum, plasma or whole blood in the clinical transport and process & EDTA K3 Tubes are used for testing whole blood in molecular diagnostics.
SUBSTANTIAL EQUIVALENCE:
The VACUETTE® EDTA K3 Tube and the Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube and Glass K3 EDTA Tube are substantially equivalent in intended use, design and composition.
Studies were conducted to demonstrate substantial equivalence of the Greiner Studies were conducted to demonet. Becton Dickinson (BD) Vacutainer® Brand PPT™ Plasma Preparation Tube and Glass K3 EDTA Tube when samples from these tubes are used in molecular diagnostic (nucleic acid PCR) assays.
The conclusion from the studies were that the HIV-1 and HCV PCR results from the The contractly healthy blood donors' and patients' samples collected in the Greiner and BD tubes were substantially equivalent.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in all capital letters.
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 Sienna Partners, L.L.C. Judi Smith Principal P. O. Box 103 Baldwin, MD 21013
FEB 0 6 2015
Re: K042927
Trade/Device Name: Greiner VACUETTE EDTA K3 Evacuated Blood Collection Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: PJE Dated: March 1, 2005 Received: March 3, 2005
Dear Ms. Judi Smith:
This letter corrects our substantially equivalent letter of April 15, 2005.
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
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Keel Sima
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): K042927
Device Name: Greiner VACUETTE® EDTA K3 Evacuated Blood Collection Tubes
Indications For Use:
VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® EDTA K3 Tubes are used for testing plasma in molecular diagnostics. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alete S
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042927