(40 days)
The Greiner Vacuette® blood collection tube with EDTA K2 is an evacuated blood collection device containing EDTA K2 anticoagulant additive and intended for use in evaluations of whole blood specimens.
The Greiner Vacuette® blood collection tube with EDTA K2 is an evacuated blood collection device containing EDTA K2 anticoagulant additive. The tube material is clear plastic.
This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request as it pertains to a blood collection tube rather than a device with diagnostic performance metrics. However, based on the provided text, I can infer and answer the relevant points to the best of my ability.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent assay results | Good correlation observed for 15 hematology parameters with paired samples. |
Explanation: For a blood collection tube, "acceptance criteria" would primarily revolve around demonstrating that the tube does not negatively impact the clinical assay results and that its performance is equivalent to a predicate device. The summary implicitly states this by evaluating "equivalency of assay results."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the number of subjects or samples used in the "paired samples" study. It only mentions "paired samples for 15 hematology parameters."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to this submission. The "ground truth" for a blood collection tube's performance isn't established by expert consensus on diagnoses, but rather by the analytical performance of the assays run on the collected blood. The "experts" involved would likely be clinical laboratory professionals determining if the analytical results are comparable. The document does not specify who performed the analyses or interpreted the "good correlation."
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in medical imaging or diagnostic studies where human readers interpret data that may have ambiguous findings. For comparing analytical assay results from blood tubes, statistical methods for correlation and equivalence would be used, not human adjudication in that sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices where multiple human readers interpret results (e.g., radiologists reading images) and the impact of an AI algorithm on their performance is being assessed. This submission is for a blood collection tube; therefore, an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a way that's applicable to this type of device. The study described is fundamentally a "standalone" analytical performance comparison of the tube itself. The performance being measured is the tube's ability to facilitate equivalent assay results, without any human diagnostic interpretation "in the loop" impacting the primary measurement of tube equivalence.
7. The Type of Ground Truth Used
The "ground truth" here is the analytical results obtained from the predicate device (Becton Dickinson Vacutainer® brand EDTA K additive tube). The Greiner Vacuette® tube's performance is judged against whether it can provide comparable analytical results to the established predicate.
8. The Sample Size for the Training Set
Not applicable. Blood collection tubes do not typically have a "training set" in the context of machine learning. Their performance is inherent to their material and additive, and assessed through analytical studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons mentioned in point 8.
§ 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.