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The VACUTAINER® Brand PLUS (plastic) Tube with EDTA and VACUTAINER® Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube. When the tube is used together with VACUTAINER® Brand Needles and Holders, it is a closed system for the collection of venous blood with the same indications as described herein.

Blood collected in PLUS EDTA and PLUS Serum tubes can be used for immunohematology testing including ABO Grouping, Rh typing and antibody screening which requires red cells and plasma or serum.

The VACUTAINER® Brand PLUS Tube with EDTA and the VACUTAINER PLUS Serum Tube are evacuated plastic blood collection tubes for collecting, transporting and processing blood in a closed plastic tube. The VACUTAINER® Brand PLUS Tube with EDTA consists of closure assembly, a plastic tube and EDTA coating (dipotassium). The VACUTAINER PLUS Serum Tube consists of closure assembly, a plastic tube and silica clot activator.

The standard closure assembly is a basic rubber stopper. The tubes are also available with the VACUTAINER® Hemogard Closure Assembly, which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. The Hemogard closure assembly, intended to reduce user exposure to blood, was described in 510(k) Premarket Notification K945952 that received FDA clearance on January 18, 1995. All stopper/closures are color coded to reflect additive type (see the chart VACUTAINER® Tube Stopper/Closure Color Code Cross Reference located in the Product Insert, Attachment D)

Here's a breakdown of the acceptance criteria and study information for the VACUTAINER® Brand PLUS Tube with EDTA Anticoagulant and VACUTAINER® Brand PLUS Serum Tube, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily focuses on establishing "substantial equivalence" to predicate devices. For the stated expanded indications (immunohematology testing), the acceptance criterion is implicitly "equivalent results" compared to the predicate glass tubes. Specific quantitative thresholds for equivalence (e.g., within certain percentage difference for specific analytes, or perfect concordance in typing) are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided text for the clinical evaluation. The document only mentions "Clinical testing to evaluate the effectiveness of the additional Indications for Use... was performed."
• Data Provenance: Not explicitly stated. There's no mention of the country of origin of the data, nor is it explicitly stated whether the study was retrospective or prospective. Given it's a premarket notification for a new indication, a prospective study design is more likely for safety and effectiveness, but this is not confirmed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the summary. The document states "Clinical testing... demonstrates equivalent performance," but it does not detail how individual results were evaluated or if "ground truth" was established by experts.

4. Adjudication Method for the Test Set

• This information is not provided in the summary. There is no mention of any adjudication process for the clinical test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. The study's aim was to demonstrate equivalent performance of the new plastic tubes compared to existing glass tubes for specific immunohematology tests. It was a comparison of device performance, not primarily a study on human reader improvement with or without AI assistance.

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. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

• The ground truth (or reference standard) for the clinical evaluation was implicitly the results obtained from the predicate VACUTAINER® Brand (glass) Serum and EDTA tubes. The study aimed to show "equivalent results" using the new plastic tubes.
  • For ABO Grouping, Rh typing, and antibody screening, the "ground truth" would be the established immunological reactions and interpretations obtained using standard methods with the predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device (blood collection tube), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

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