(175 days)
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.
VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. VACUETTE® EDTA K3 Tubes are used for testing whole blood in molecular diagnostics.
The provided document describes the 510(k) summary for the Greiner VACUETTE® EDTA K3 Tubes, which are an evacuated blood collection system. The primary goal of the submission was to demonstrate substantial equivalence to predicate devices (Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube and Glass K3 EDTA Tube) for use in molecular diagnostics.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Substantial equivalence of HIV-1 PCR results when samples are collected in Greiner and BD tubes. | The conclusion from the studies was that the HIV-1 PCR results from the contractually healthy blood donors' and patients' samples collected in the Greiner and BD tubes were substantially equivalent. |
| Substantial equivalence of HCV PCR results when samples are collected in Greiner and BD tubes. | The conclusion from the studies was that the HCV PCR results from the contractually healthy blood donors' and patients' samples collected in the Greiner and BD tubes were substantially equivalent. |
| (Implied) Samples from Greiner tubes can be used in molecular diagnostic (nucleic acid PCR) assays, similar to predicate devices. | Studies were conducted to demonstrate substantial equivalence... when samples from these tubes are used in molecular diagnostic (nucleic acid PCR) assays. The device is intended for "testing plasma in molecular diagnostics." |
| (Implied) The device functions as an evacuated blood collection system for venous blood collection. | VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "contractually healthy blood donors' and patients' samples," but does not specify the exact number of individuals or samples used in the studies.
- Data Provenance: The document does not explicitly state the country of origin for the data. The study appears to be prospective as it involved collecting samples (from healthy donors and patients) specifically for the purpose of the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study appears to rely on PCR test results as the "ground truth" for molecular diagnostic performance, rather than expert consensus on an image or clinical assessment.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The study focuses on laboratory test results (HIV-1 and HCV PCR), not subjective clinical assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic tools that aid human interpretation, which is not the function of a blood collection tube. The study compared the performance of blood samples collected in different tubes on molecular diagnostic assays.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable in the context of this device. The device itself is a blood collection tube, not an algorithm. The "performance" being evaluated is the chemical and physical compatibility of the tube with subsequent molecular diagnostic tests, essentially ensuring the collected sample remains viable and produces equivalent results to samples collected in predicate devices. The PCR assays themselves are standardized laboratory procedures, not AI algorithms.
7. The Type of Ground Truth Used
The ground truth used was molecular diagnostic assay results (HIV-1 and HCV PCR results). The "truth" was established by the output of these laboratory tests performed on samples collected in both the test device and the predicate device, with the expectation that the results would be "substantially equivalent."
8. The Sample Size for the Training Set
This information is not applicable/provided. The device is a physical medical device (blood collection tube), not an AI algorithm that requires a training set. The "studies" mentioned refer to performance validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, there is no training set for this 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.