(112 days)
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)
| Parameter | Acceptance Criteria (MD 800 Specification) | Predicate Device (Coulter STKS) Performance | MD 800 Reported Performance (from Table) |
|---|---|---|---|
| Precision | |||
| WBC |
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”