(245 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and performance of blood collection tubes, with no mention of AI or ML.
No
The device is used for collecting and processing blood samples for diagnostic testing, not for treating a disease or condition.
No.
The device is a blood collection tube used for obtaining blood samples for testing, not for diagnosing a condition itself.
No
The device description clearly indicates it is a physical blood collection tube made of polypropylene, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the tubes are "designed for the collection, transportation and processing of capillary blood... for testing parameters in hematology." This clearly indicates that the collected blood is intended for in vitro diagnostic testing.
- Device Description: The description mentions the presence of K2EDTA, which is an additive used to prevent blood clotting for specific types of in vitro diagnostic tests (hematology).
- Performance Studies: The performance study compares the results from samples collected in these tubes to predicate devices used in hematology assays. This further reinforces the device's role in diagnostic testing.
The device is a container specifically designed to collect and prepare a biological specimen (blood) for subsequent in vitro diagnostic procedures.
N/A
Intended Use / Indications for Use
Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes are designed for the collection, transportation and processing of capillary blood (collected via lancet stick) whenever a small amount of blood is preferred.
Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are used to obtain whole blood for testing parameters in hematology.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA are nonevacuated, non-sterile, low sample volume tubes made from virtually unbreakable, highly transparent polypropylene. The tube measures 11 x 40 mm and there is a predefined nominal fill volume of 0.5 mL for achieving correct additive concentrations.
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)
A study was conducted to demonstrate substantial equivalence of theGreiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA with the Greiner Bio-One VACUETTE® Blood Collection Tube with K2EDTA (K014104) and the Becton Dickinson Microtainer® Tube with K2EDTA (K940905) when samples from these tubes are used in hematology assays.
The conclusion from the study is that the hematology results from samples collected in the Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are substantially equivalent to those collected in the predicate tubes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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
JUL 1 0 2007 November 3, 2006
CONTACT: Douglas L. Harris Greiner Vacuette North America, Inc. 4238 Capital Drive Monroe, NC 28110
NAME OF DEVICE: Greiner Bio-One MiniCollect® Capillary Blood Collection Trade Name: Tubes with dipotassium EDTA (K2EDTA) Common Names/Descriptions: Blood Collection System Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection VACUETTE® PREDICATE DEVICES: Greiner Bio-One Evacuated Blood Collection Tube with K2EDTA (K014104); Becton Dickinson Microtainer® Tube with K2 EDTA (K940905)
DEVICE DESCRIPTION:
Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA are nonevacuated, non-sterile, low sample volume tubes made from virtually unbreakable, highly transparent polypropylene. The tube measures 11 x 40 mm and there is a predefined nominal fill volume of 0.5 mL for achieving correct additive concentrations.
INTENDED USE:
Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes are designed for the collection, transportation and processing of capillary blood (collected via lancet stick) whenever a small amount of blood is preferred.
Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are used to obtain whole blood for testing parameters in hematology.
SUBSTANTIAL EQUIVALENCE:
Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA are substantially equivalent to the Greiner Bio-One VACUETTE® Blood Collection Tube with K2EDTA (K014104) and the Becton Dickinson Microtainer® Tube with K2EDTA (K940905) in intended use, design and composition.
A study was conducted to demonstrate substantial equivalence of theGreiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA with the Greiner Bio-One VACUETTE® Blood Collection Tube with K2EDTA (K014104) and the Becton Dickinson Microtainer® Tube with K2EDTA (K940905) when samples from these tubes are used in hematology assays.
The conclusion from the study is that the hematology results from samples collected in the Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are substantially equivalent to those collected in the predicate tubes.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 0 2007
Douglas L. Harris Greiner Vacuette North America, Inc. 4238 Capital Drive Monroe, North Carolina 28110
Re: K063357
. Trade/Device Name: Greiner Bio-One MiniCollect Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Collection System Regulatory Class: Class II Product Code: JKA Dated: June 13, 2007 Received: June 15, 2007
Dear Mr. Harris:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
2
Page 2 – Douglas L. Harris
will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert H. Becker
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
3
Page 3 – Douglas L. Harris
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ- Division D.O.
:
.
:
and the comments of the comments of
:
4
Indications for Use
510(k) Number (if known): K063357
Device Name: Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA)
Indications for Use:
Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes are designed for the collection, transportation and processing of capillary blood (collected via lancet stick) whenever a small amount of blood is preferred.
Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are used to obtain whole blood for testing parameters in hematology.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Josephine Bautista
Division Sign Off
Office of In Vitro Diagn
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K063357