(59 days)
Greiner VACUETTE® Trace Elements Evacuated Blood Collection Tubes with sodium heparin or no additive are used to collect, transport and process blood for testing plasma, serum, or whole blood for trace elements 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® Trace Elements tube with sodium heparin may be used to collect a whole blood/plasma sample. The VACUETTE® Trace Elements tube with no additive may be used to collect a serum sample. The tubes are composed of clear plastic. The caps are roval blue and made of plastic and rubber: the inner cap rings are black and made of plastic. The tubes' size is 13 x 75 mm. 6mL draw. The tubes are equipped with a vacuum tube holder to assist in positioning the product when obtaining blood samples. The vacuum tube holder is composed of plastic.
The Greiner VACUETTE® Trace Elements Tubes were evaluated through two studies to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| No background presence of trace elements in the tubes. | "Test results for trace elements to be claimed showed no background presence of trace elements in the tubes." |
| Equivalent performance with blood samples compared to the predicate device. | "equivalent performance with blood samples." |
2. Sample Size and Data Provenance
- Sample Size (Test Set): 40 blood donors for the comparison testing with blood samples. The sample size for the deionized water testing is not specified, but it implies multiple tubes were tested.
- Data Provenance: Not explicitly stated, but given the submission is to the FDA, it is highly likely the studies were conducted in the US. The studies were likely prospective, as they involved collecting blood from donors specifically for the purpose of testing the new device.
3. Number of Experts and Qualifications
- This information is not provided in the document. The studies focused on analytical performance (presence of trace elements, comparison of results) rather than diagnostic interpretation requiring expert consensus.
4. Adjudication Method
- Not applicable. The studies involved analytical testing of trace element levels, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study (comparing human reader performance with and without AI assistance) is not relevant for this device, which is a blood collection tube and not an AI diagnostic tool.
6. Standalone Performance Study
- Yes, implicitly. The study testing for the "background presence of trace elements in the tubes using deionized water" functions as a standalone performance assessment to ensure the tubes themselves do not contribute contaminants. The comparison testing with blood samples also assesses the device's performance in its intended use, albeit in comparison to a predicate.
7. Type of Ground Truth Used
- The ground truth for the deionized water study was the absence of trace elements in the deionized water itself. The device's performance was measured against this known clean baseline.
- The ground truth for the comparison testing with blood samples was the predicate device's performance. The results obtained from the Greiner VACUETTE® tubes were compared to those obtained using the Becton Dickinson Vacutainer® Trace Elements tube. The assumption is that the predicate device provides accurate (or substantially equivalent) measurements of trace elements in blood.
8. Sample Size for the Training Set
- Not applicable. This device is a blood collection tube, not an algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
- Not applicable. As stated above, there is no training set for this device.
§ 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.