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BD Microtainer® MAP Microtube for Automated Process with K2EDTA is used to collect, anticoagulate, transport and store skin puncture blood specimens for measurement of the following hematological parameters:

White Blood Cells (WBC), Red Blood Cells (RBC), Hernoglobin (HgB), Hematocrit (HCT), Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), White Blood Cell (WBC) differentials (Neutrophils, Platelets, 5-part Lymphocytes, Monocytes, Eosinophils, Basophils), Reticulocytes and Whole Blood Lead testing.

BD Microtainer® MAP Microtube for Automated Process consists of a plastic reservoir and a lavender cap indicating the presence of K2EDTA. The interior surface of the reservoir is spray-coated with K-EDTA solution, which is then dried. The upper edge of the reservoir serves as a collector for blood specimen. The plastic reservoir is a one piece design - reservoir and extender, which were previously two separate components in the predicate device (K940905).

The integrated extender gives the tube an external dimension of a standard tube (13x75mm), while maintaining the same internal characteristics for low specimen volume range and K2EDTA blood to additive ratio as the predicate. The lavender cap features a penetrable septum.

These integrated features; one piece reservoir/extender and penetrable cap adapts the tube for compatibility with high throughput hematology instruments. Once the blood specimen is collected and mixed adequately, there is no longer a need to remove the cap, transfer the sample to a suitable container or add an additional component to fit tube racks.

BD MAP can be directly processed on high throughput hematology instruments. Markings on the reservoir indicate a blood specimen fill range of 250uL. There is also a tube marking for specimen fill (375uL) when the tube is processed in automated mode.

While BD MAP is adaptable to automated processing: the tube remains compatible with automated instruments when processed in the manual mode.

The provided 510(k) summary for the BD Microtainer® MAP Microtube for Automated Process does not include detailed acceptance criteria or a specific study proving the device meets said criteria in the format requested.

It describes the device, its intended use, and states that "Mechanical, simulated use and clinical testing were performed to demonstrate the device's safety and effectiveness." However, it does not provide the specifics of these tests, such as:

• Quantitative acceptance criteria (e.g., ±X% difference from predicate, specific statistical thresholds for correlation).
• Detailed performance results for each hematological parameter listed.
• Sample sizes for test or training sets.
• Data provenance, ground truth establishment methods, or expert qualifications.
• Information on MRMC studies or standalone algorithm performance.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (BD Microtainer® K2EDTA tube with Microgard TM Closure and Extender, K940905) based on device features, materials, intended use, and general performance claims.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the information provided in this 510(k) summary. The summary is high-level and does not delve into the detailed study methodology and results typically found in full study reports or more comprehensive regulatory submissions.

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