(28 days)
To collect, transport, separate and process capillary blood for testing plasma in the clinical laboratory.
The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing lithium heparin anticoagulant and an inert acrylic barrier material, intended to collect, transport, separate and process capillary blood for testing serum.
The provided text describes a 510(k) summary for the Greiner MiniCollect® Lithium Heparin Gel tube. The study focuses on demonstrating substantial equivalence to a predicate device, not on specific acceptance criteria for a new clinical performance claim. Therefore, the requested information about acceptance criteria for a device, MRMC studies, ground truth establishment, and training set details are not fully applicable or available in the provided text.
However, based on the provided text, here's an attempt to extract relevant information and note what is not applicable or provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Becton Dickinson's Microtainer® Brand heparin tubes with gel separator). | "Test results from paired samples for 22 analytes and 4 hormones were evaluated demonstrating good correlation." The formal acceptance criteria for "good correlation" are not explicitly stated (e.g., specific correlation coefficient thresholds). |
| Same intended use as the predicate device. | The Greiner MiniCollect® is intended "to collect, transport, separate and process capillary blood for testing serum," which is the same intended use as the predicate. |
| Made of the same material as the predicate device. | Both tubes are made of "polypropylene plastic." |
2. Sample size used for the test set and the data provenance
- Sample Size: "paired samples for 22 analytes and 4 hormones" were evaluated. The exact number of patients or individual samples is not specified, but it implies multiple samples for each of the 26 assessed parameters.
- Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/provided. The study compared the performance of two blood collection tubes rather than relying on expert interpretation for a "ground truth" diagnosis. The "ground truth" for the analytes/hormones would be established by standard assay methods, which are inherently part of the test.
4. Adjudication method for the test set
- Not applicable/provided. There was no expert adjudication process described as the study compared analytical results from two devices.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a blood collection tube, not an AI-powered diagnostic system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a blood collection tube, not an AI algorithm. The performance evaluation was based on analytical results of blood collected in the tubes.
7. The type of ground truth used
- The "ground truth" in this context refers to the analytical results obtained from the predicate device, Becton Dickinson's Microtainer® Brand heparin tubes with gel separator. The study aimed to show that the new device yielded comparable analytical results. The "ground truth" for the analytes themselves would be the accuracy and precision of the respective laboratory assays.
8. The sample size for the training set
- Not applicable. This study does not involve a training set as it's a comparison of two physical medical devices, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
§ 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.