(27 days)
VACUETTE® tubes with sodium heparin are used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.
VACUETTE® Tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. The VACUETTE® tube with sodium heparin may be used to collect a whole blood/plasma sample. The tube is composed of clear plastic. The cap is made of plastic and rubber. The tube size is 13 x 75 mm. The tube is equipped with a vacuum tube holder to assist in positioning the product when obtaining blood samples. The vacuum tube holder is composed of plastic.
Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Device Performance for Greiner VACUETTE® Evacuated Blood Collection Tubes with Sodium Heparin (K011699)
This 510(k) summary focuses on demonstrating "substantial equivalence" of the new device to a predicate device, rather than explicit, numerical acceptance criteria for various performance metrics. The core acceptance criterion is that the new device (sodium heparin tube) performs equivalently to the predicate device (lithium heparin tube) for commonly tested plasma analytes.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Greiner VACUETTE® tube with lithium heparin - K# 960857) | The Greiner VACUETTE® tube with sodium heparin was found to be substantially equivalent to the Greiner VACUETTE® tube with lithium heparin. |
| Same Intended Use as Predicate Device | Both devices have the same intended use: collection, transport, and processing of blood for testing serum, plasma, or whole blood in the clinical laboratory. Specific to these plasma tubes, their intended use is for testing plasma or whole blood. |
| Same Tube Material and Stopper Material as Predicate Device | Both blood collection tubes have the same tube material and stopper material. |
| Equivalent Performance of 27 Analytes Commonly Tested in Plasma Compared to Predicate Device (Lithium Heparin) | A study demonstrated "equivalent performance" of the two anticoagulants (sodium heparin and lithium heparin) for 27 analytes commonly tested in plasma. While specific numerical acceptance thresholds (e.g., within X% difference, correlation coefficient > Y) are not explicitly stated, "equivalent performance" implies that the differences observed were within clinically acceptable limits, justifying substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Blood collected from 40 donors.
- Data Provenance: Not explicitly stated (e.g., country of origin, ethnicity). It is a prospective study, as blood was collected specifically for this comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This study does not involve human readers establishing ground truth for diagnostic accuracy, but rather a direct comparison of analytical equivalence between two medical devices for laboratory assays. The "ground truth" here is the measured analyte concentration/activity, determined by an assay performed in a clinical laboratory setting. The experts involved would be laboratory personnel performing the analyses, but their qualifications and numbers are not detailed as they would be for image interpretation.
4. Adjudication Method for the Test Set
Not applicable. This is an analytical equivalence study, not an diagnostic accuracy study involving multiple readers and adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI algorithms interpreting medical images or other diagnostic data, where human readers interact with the AI. This 510(k) is for a basic blood collection device comparing the performance of different anticoagulant additives.
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. Its performance is intrinsic to the chemical and physical characteristics of the tube and its additives, affecting subsequent laboratory analyses.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measured values of 27 analytes commonly tested in plasma. This is essentially laboratory reference measurements obtained from clinical laboratory assays. The comparison is between the values obtained from blood collected in the sodium heparin tube versus the lithium heparin tube.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this device is not an AI/machine learning algorithm.
§ 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.