Search Results

The MD 800 is a multi-parameter, automated hematology analyzer used to perform in vitro diagnosis of peripheral human blood in clinical laboratories.

The MD 800 reports on the following parameters:

White Blood Cells (Leukocytes) WBC
Red Blood Cells (Erythrocytes) RBC
Hemoglobin Concentration Hgb
Hematocrit (relative volume of erythrocytes) Hct
Mean Corpuscular (erythrocyte) Volume MCV
Mean Corpuscular (erythrocyte) Hemoglobin MCH
Mean Corpuscular (erythrocyte) Hemoglobin Concentration MCHC
Red Blood Cell (erythrocyte volume) Distribution Width RDW
Platelet or Thrombocyte Count Plt
Mean Platelet (thrombocyte) Volume MPV
Lymphocyte (number) LY#
Lymphocyte (percent of WBC) LY%
Monocyte (number) MO#
Monocyte (percent of WBC) MO%
Basophil (number) BA#
Basophil (percent of WBC) BA %
Neutrophil (number) NE#
Neutrophil (percent of WBC) NE%
Eosinophil (number) EO#
Eosinophil (percent of WBC) EO %

The MD 800 is a quantitative analyzer of peripheral human blood for in vitro diagnostic use in clinical laboratories. It performs an automated complete blood count (CBC) and a leukocyte differential on peripheral human blood. A sample volume of 20 uL of whole blood is required. The instrument provides a printed report on 20 parameters. The MD 800 consists of five components: (1) A blood analysis instrument, (2) A reagent dispensing unit and four reagents, (3) Calibration and control reagents, (4) Probeclenz™, a cleaning liquid, and (5) A standard, off-the-shelf high resolution printer. The instrument uses precise, motorized syringes, electronically controlled valves, cuvettes, transducer chambers, connective tubing and wiring, a communications panel, and a computer and related software program to analyze the blood sample.

The MASCOT MD Hematology Analyzer Model MD 800 is an automated differential blood cell counter. The provided document details its technical specifications, principle of operation, and studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device, the Coulter Model STKS.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are primarily defined by the precision and linearity specifications, and the device's performance is listed alongside its predicate device (Coulter STKS) in Figure 8-1. The document asserts that the MD 800 performs within the normal and expected range for automated hematology instruments and is comparable to the Coulter STKS.

Acceptance Criteria & Reported Performance (from Figure 6-1 & 8-1)

Ask a specific question about this device