(26 days)
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Not Found
No
The description focuses on the physical characteristics and performance of a blood collection tube and its centrifugation parameters, with no mention of AI or ML.
No
This device is described as a blood collection tube used for testing plasma in a clinical laboratory, not for direct therapeutic intervention on a patient.
No
Explanation: This device is a blood collection tube used to prepare blood samples for testing. It does not perform any diagnostic function itself but is an accessory for diagnostic tests performed on the collected blood.
No
The device description clearly describes a physical blood collection tube with a gel separator, which is a hardware component. The changes described relate to the instructions for use regarding centrifugation parameters, not the software itself.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the tubes are used "to collect, transport and process blood for testing plasma in the clinical laboratory." This directly aligns with the definition of an IVD, which are devices used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details how the tubes are used to prepare a blood specimen (separating plasma from cells) for subsequent testing. This preparation step is integral to the in vitro diagnostic process.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is where in vitro diagnostic testing is performed.
The information provided clearly indicates that this device is designed and intended to be used in the process of performing diagnostic tests on human blood specimens outside of the body, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
VACUETTE Blood Collection Tubes with Lithium Heparin and Gel Separator are used to collect, transport and process blood for testing plasma in the clinical laboratory.
Product codes
JKA
Device Description
VACUETTE® Evacuated Blood Collection Tubes are plastic tubes with a pre-defined vacuum for exact draw volumes. They are fitted with color coded VACUETTE® Safety Caps (green for heparin tubes). The tubes, additive concentrations, volumes of liguid additives, and their permitted tolerances, as well as the blood-to-additive ratio, are in accordance to the requirements and recommendations of the international standards ISO 6710 "Single use containers for venous blood specimen collection" and the Clinical and Laboratory Standards Institute's Approved Standards (CLSI).
VACUETTE® Evacuated Blood Collection Tubes with Lithium Heparin and Gel contain a barrier gel in the tube. The specific gravity of this material lies between the blood cells and plasma. During centrifugation the gel barrier moves upward, where it forms a stable barrier separating the plasma from cells. Plasma may be aspirated directly from the collection tube, which eliminates the need for transfer to another container.
The changes for the VACUETTE® Evacuated Blood Collection Tube with Lithium Heparin and Gel are in the Instructions for Use (IFU):
- Recommended g-force (relative centrifugal force, rcf) change from 2200 g to . a range of 1800 - 2200 g.
- Recommended tube spin time change from 15 minutes to a range of 10 15 . minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory
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)
Study Type: Method comparison study.
Sample Size: 40 patients.
Key results:
- Visually inspected all of the tubes after centrifugation and before starting analysis: 99% of the time all gel barriers must be properly formed and stable. Result: Passed: All met acceptance criteria (100% of tubes formed stable gel barriers).
- All test results must yield: 1. Deming slope of 1.0 +/- 0.1 2. No statistically significant difference between results: using Deming Method, the 95% confidence intervals include the ideal values (i.e. 0.00 in constant bias or 1.00 in proportional bias). Result: Passed: All met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
NOV - 9 2010
November 8, 2010
510(k) SUMMARY
CONTACT:
47
Manfred Abel Greiner Bio-One North America, Inc. P.O Box 1026 Monroe, NC 28111
NAME OF DEVICE:
Trade Name:
Common Names/Descriptions: Classification Name:
Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel Evacuated Blood Collection System Tubes, Vials, Systems, Serum Separators, Blood Collection
PREDICATE DEVICE:
Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel
DEVICE DESCRIPTION:
INTENDED USE:
VACUETTE® Blood Collection Tubes with Lithium Heparin and Gel Separator are used to collect, transport and process blood for testing plasma in the clinical laboratory.
DESCRIPTION:
VACUETTE® Evacuated Blood Collection Tubes are plastic tubes with a pre-defined vacuum for exact draw volumes. They are fitted with color coded VACUETTE® Safety Caps (green for heparin tubes). The tubes, additive concentrations, volumes of liguid additives, and their permitted tolerances, as well as the blood-to-additive ratio, are in accordance to the requirements and recommendations of the international standards ISO 6710 "Single use containers for venous blood specimen collection" and the Clinical and Laboratory Standards Institute's Approved Standards (CLSI).
VACUETTE® Evacuated Blood Collection Tubes with Lithium Heparin and Gel contain a barrier gel in the tube. The specific gravity of this material lies between the blood cells and plasma. During centrifugation the gel barrier moves upward, where it forms a stable barrier separating the plasma from cells. Plasma may be aspirated directly from the collection tube, which eliminates the need for transfer to another container.
The changes for the VACUETTE® Evacuated Blood Collection Tube with Lithium Heparin and Gel are in the Instructions for Use (IFU):
- Recommended g-force (relative centrifugal force, rcf) change from 2200 g to . a range of 1800 - 2200 g.
- Recommended tube spin time change from 15 minutes to a range of 10 15 . minutes.
1
SUBSTANTIAL EQUIVALENCE:
The Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel described in this submission is substantially equivalent to the predicate device in intended use, design, or composition of the tube. Verification studies were performed to demonstrate that the lower centrifugation speed and time did not affect laboratory results compared to the current centrifugation speed and time. The following table summarizes the validation and verification studies, the acceptance criteria, and the results.
| Parameters | Risks | Tests
Performed | Pre-Determined
Acceptance
Criteria | Test Results |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Modification of
the centrifuge g
force and time
(From 15
minutes at 2200
g to 10 minutes
at 1800 g) | 1. Incomplete
gel barrier
formation
causing
incomplete
separation of
plasma and red
blood cells | Method
comparison
study between
the current
centrifuge
speed and time
versus the
modified
centrifuge
speed and time
from 40 patients
(51 analytes
tested) | Visually
inspected all of
the tubes after
centrifugation and
before starting
analysis: 99% of
the time all gel
barriers must be
properly formed
and stable | Passed: All met
acceptance
criteria
(100% of tubes
formed stable
gel barriers) |
| | 2. Inaccurate
results of the
analytes tested
from the
plasma | Method
comparison
study between
the current
centrifuge
speed and time
versus the
modified
centrifuge
speed and time
from 40 patients
(51 analytes
tested) | All test results
must yield:
- Deming slope
of $1.0 \pm 0.1$ - No statistically
significant
difference
between results:
using Deming
Method, the 95%
confidence
intervals include
the ideal values
(i.e. 0.00 in
constant bias or
1.00 in
proportional bias) | Passed: All met
acceptance
criteria |
rv of the Verification and Validation Activity Q.
The analysis of the data from this study demonstrated that the current modified centrifugation conditions for the VACUETTE® Evacuated Blood Collection System are equivalent and can be used for a broad range of clinical chemistry and immunology tests.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration · 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Greiner Bio-One North America, Inc. c/o Judi Smith, LLC, Principal PO Box 103 Baldwin, MD 21013 USA
Re: K103041
Trade Name: Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Codes: JKA Dated: October 5, 2010 NOV - 9 2010 Received: October 14, 2010
Dear Ms. Smith:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courthey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use
NOV - 9 2010
510(k) Number (if known): K103041
Device Name: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel
Indication For Use:
டு VACUETTE Blood Collection Tubes with Lithium Heparin and Gel Separator are used to collect, transport and process blood for testing plasma in the clinical laboratory.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K 103041 510(k)