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510(k) Data Aggregation
(53 days)
To collect, transport, store and process blood for testing serum in the clinical laboratory. In addition, tubes are suitable for therapeutic drug monitoring.
The Greiner VACUETTE® blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator and an inert polymeric barrier material.
The provided text describes a 510(k) submission for a labeling change to the Greiner VACUETTE® blood collection tube. The change is to include therapeutic drug monitoring (TDM) as an indicated use. The submission aims to demonstrate substantial equivalence to both Greiner's previously cleared device (K960858) and Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for agreement, bias, or precision). However, the implicit acceptance criterion is "no significant clinical difference" between the modified Greiner VACUETTE® tubes and the predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| No significant clinical difference compared to previously cleared Greiner VACUETTE® tubes (K960858) | "No clinically significant difference was noted in these comparison studies." |
| No significant clinical difference compared to Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes | "No clinically significant difference was noted in these comparison studies." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "clinical tests" and "comparison studies" but does not provide details on the number of samples or subjects involved.
- Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a blood collection tube, and the "ground truth" for its performance comparison would typically involve laboratory measurements and statistical analysis of collected blood samples, not expert interpretation of images or other subjective data.
4. Adjudication Method for the Test Set:
Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable for this type of device. MRMC studies are typically used for evaluating diagnostic imaging or AI devices where human reader performance is a key outcome.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device (blood collection tube), not an algorithm or AI.
7. Type of Ground Truth Used:
The "ground truth" in this context refers to the results obtained from analyses of blood samples collected in the predicate devices. The study compares the performance of the Greiner VACUETTE® tubes (with and without gel separator, and with the proposed TDM indication) against these established methods. The comparison likely involved measuring various analytes relevant to therapeutic drug monitoring and other clinical laboratory tests.
8. Sample Size for the Training Set:
Not applicable. This is a physical device, not a machine learning algorithm that requires a training set. The "studies" mentioned are performance comparison studies, not model training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
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