(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: |
- 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. |
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.
§ 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.