(26 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel:
Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel Study Analysis
This 510(k) submission describes verification studies performed to demonstrate that a modified centrifugation speed and time for the Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel does not affect laboratory results compared to the original parameters.
1. Acceptance Criteria and Reported Device Performance
| Parameter Tested | Pre-Determined Acceptance Criteria | Test Results |
|---|---|---|
| Incomplete gel barrier formation causing incomplete separation of plasma and red blood cells (Risk 1) | 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). |
| Inaccurate results of the analytes tested from the plasma (Risk 2) | All test results must yield: 1. Deming slope of $1.0 \pm 0.1$ 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). | Passed: All met acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 40 patients
- Data Provenance: Not explicitly stated, but assumed to be from a clinical laboratory context as it involves analyzing patient samples for various analytes. It is a prospective study as it involves actively performing comparisons between two centrifugation conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for this study is not established by human experts but by quantitative laboratory measurements and statistical analysis.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This study involves quantitative measurements and statistical comparisons, not subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This study does not involve human readers evaluating images or data with and without AI assistance. It focuses on the physical performance of a medical device (blood collection tube) under different operating conditions.
- Effect Size of AI improvement: Not applicable.
6. Standalone Performance Study
- Standalone Study Done: Yes, in a way. The study assesses the performance of the modified centrifugation parameters (the "device" being tested in terms of its new operating conditions) in isolation by comparing results obtained under these new conditions against results obtained under the predicate device's conditions. It's an "algorithm-only" or "device-only" performance in the sense that it doesn't involve a human-in-the-loop for decision-making based on the output.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth is the scientific and statistical determination of equivalence based on:
- Visual inspection for gel barrier formation: This serves as a qualitative "ground truth" for physical separation.
- Quantitative analytical results for 51 analytes: The "ground truth" for these measurements is the established accuracy and precision of the laboratory analytical instruments used, and the comparison to the existing (predicate) centrifugation method within specified statistical bounds (Deming regression, confidence intervals).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This study is a verification and validation study comparing a modified process to an existing one. It does not involve machine learning or AI models that require a separate training set. The "training" here could be conceptualized as the initial development and optimization of the centrifugation parameters, but no specific data set is mentioned as a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set in the context of machine learning. The "ground truth" for establishing the original operating parameters would have been through prior research, development, and validation studies that determined optimal centrifugation settings for the device.
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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.
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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 | TestsPerformed | Pre-DeterminedAcceptanceCriteria | Test Results |
|---|---|---|---|---|
| Modification ofthe centrifuge gforce and time(From 15minutes at 2200g to 10 minutesat 1800 g) | 1. Incompletegel barrierformationcausingincompleteseparation ofplasma and redblood cells | Methodcomparisonstudy betweenthe currentcentrifugespeed and timeversus themodifiedcentrifugespeed and timefrom 40 patients(51 analytestested) | Visuallyinspected all ofthe tubes aftercentrifugation andbefore startinganalysis: 99% ofthe time all gelbarriers must beproperly formedand stable | Passed: All metacceptancecriteria(100% of tubesformed stablegel barriers) |
| 2. Inaccurateresults of theanalytes testedfrom theplasma | Methodcomparisonstudy betweenthe currentcentrifugespeed and timeversus themodifiedcentrifugespeed and timefrom 40 patients(51 analytestested) | All test resultsmust yield:1. Deming slopeof $1.0 \pm 0.1$2. No statisticallysignificantdifferencebetween results:using DemingMethod, the 95%confidenceintervals includethe ideal values(i.e. 0.00 inconstant bias or1.00 inproportional bias) | Passed: All metacceptancecriteria |
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.
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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).
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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
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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)
§ 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.