(30 days)
The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive and intended for use in evaluations of coagulation analyses.
The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive. The tube material for the Greiner product is clear plastic.
This document is a 510(k) summary for a blood collection tube, not a medical device involving AI or complex algorithms. Therefore, much of the requested information (e.g., AI performance, expert consensus, training sets, MRMC studies) is not applicable.
Here's the relevant information based on the provided text:
I. Acceptance Criteria and Study Details for Greiner Vacuette® Blood Collection Tube with Sodium Citrate
This submission describes a direct comparison study to establish substantial equivalence for a new medical device (blood collection tube) with an existing predicate device. The acceptance criteria and performance are based on the correlation of results from these two devices for specific laboratory tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter Tested | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Coagulation Analyses (2 parameters) | "Good correlation" of test results between the Greiner Vacuette® tube and the predicate Becton Dickinson Vacutainer® tube. | "Good correlation was observed." |
Note: The document does not explicitly state numerical acceptance criteria (e.g., correlation coefficient thresholds). Instead, it uses the qualitative term "good correlation."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The study involved "paired samples."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, given the nature of a 510(k) submission for a physical device, it's highly likely to be prospective clinical laboratory testing conducted in a controlled environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable: For a blood collection tube, "ground truth" is established by the analytical results of standardized laboratory tests. There are no human experts interpreting images or making diagnoses in this context to establish a conventional "ground truth." The "ground truth" is effectively the result obtained from the predicate device which is considered the standard.
4. Adjudication Method for the Test Set
- Not Applicable: Adjudication methods are typically used for subjective diagnostic tasks (e.g., image interpretation). This study involves objective laboratory measurements. The comparison is direct, not interpretive.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: An MRMC comparative effectiveness study is not applicable as this device is a blood collection tube, not an AI-powered diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable: This is a physical blood collection device, not an algorithm, so "standalone performance" in the AI sense is not relevant. The performance is the analytical result generated by the laboratory instrument after blood collection in the tube.
7. The Type of Ground Truth Used
- Comparator Device Results: The "ground truth" or reference standard for comparison was the results obtained from the Becton Dickinson Vacutainer® sodium citrate tube (predicate device). The equivalency was evaluated by comparing test results from the new device against the established predicate.
8. The Sample Size for the Training Set
- Not Applicable: This is a physical medical device, not an AI model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set for this type of device, this question is irrelevant.
§ 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.