(112 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms. The description focuses on standard automated hematology analysis techniques and components.
No.
The device is an in vitro diagnostic (IVD) device used for analysis of blood samples, not for treating patients.
Yes
Explanation: The "Intended Use / Indications for Use" explicitly states that "The MD 800 is a multi-parameter, automated hematology analyzer used to perform in vitro diagnosis of peripheral human blood in clinical laboratories." Additionally, the "Device Description" states it is "for in vitro diagnostic use."
No
The device description explicitly states that the MD 800 consists of multiple hardware components including a blood analysis instrument, reagent dispensing unit, calibration and control reagents, cleaning liquid, and a printer, in addition to the computer and software. This indicates it is a hardware device with integrated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "The MD 800 is a multi-parameter, automated hematology analyzer used to perform in vitro diagnosis of peripheral human blood in clinical laboratories." The phrase "in vitro diagnosis" is a key indicator of an IVD.
- Device Description: The "Device Description" section also reinforces this by stating: "The MD 800 is a quantitative analyzer of peripheral human blood for in vitro diagnostic use in clinical laboratories."
- Function: The device analyzes peripheral human blood samples to report on various hematology parameters. This analysis of biological samples outside of the body for diagnostic purposes is the core function of an IVD.
- Clinical Setting: The intended user and care setting are "clinical laboratories," which are environments where IVD devices are typically used for diagnostic testing.
N/A
Intended Use / Indications for Use
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 % |
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
In General. 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.
Components. The MD 800 consists of five components:
(1) A blood analysis instrument (the "instrument") with external cord and grounded plug for connection to a standard 110V AC outlet.
Externally, this instrument has an external diluter probe for the intake of blood samples and a communications panel consisting of red and green LED lights, a communications screen which provides messages to prompt the operator, and a keypad for operator input.
Internally, the instrument in general consists of three precise, motorized syringes used to move the blood sample, a series of electronically controlled valves which direct its flow, cuvette used to mix reagents with measured quantities of the sample, a transducer chamber used to count the blood cells, another transducer chamber used to determine hemoglobin levels, connective tubing and wiring, the communications panel described above and a computer and related software program used to direct the instrument in taking a series of steps necessary to analyze the sample and produce a report.
(2) A reagent dispensing unit connected to the instrument by tubes and four reagents (described below in "Reagents") used in it.
(3) Calibration and control reagents consisting of a reagent used to calibrate the MD 800 as directed in the Manual and another reagent used according to good laboratory practices at the beginning and end of each group of samples, or in long runs, at established intervals to verify operation of the instrument (these reagents are described below in "Reagents").
(4) Probeclenz™, a cleaning liquid described below in Reagents.
(5) A standard, off-the-shelf high resolution printer selected by the manufacturer to print the report of the analysis.
How the MD 800 functions:
After calibration and initial testing, the operator mixes a sample of EDTA-treated human blood, and causes the MD800 to aspirate a 20 uL samaple of the blood sample into the instrument. After a few additional short steps, the instrument automatically performs all remaining functions necessary to complete the analysis of the blood sample. The operator has no other function except appropriate handling of the printed report. An analysis of a blood sample takes approximately 5 minutes.
Following a sequence of steps, the MD 800 creates both a red blood cell ("RBC") dilution and a white blood cell ("WBC") dilution using the HEMA-SET" reagents described below and then analyses the resulting dilutions. The steps are as follows:
(1) The instrument creates a stock dilution by drawing precise quantities of specific reagents (described below in "Reagents") from the reagent box and mixes them with 20 uL of whole blood sample by opening valves and the operation of the motorized syringes. The sample is mixed by bubbling air through the measured reagent/blood sample mix. 10 uL of the stock dilution is reaspirated into the aspirator probe and reserved for the RBC/Plt analvsis.
(2) To determine WBC and hemoglobin, the instrument again draws precise quantities of specific reagents from the reagent box and mixes them with the remaining stock dilution. This dilution is again mixed by bubbling air through the reagent/blood stock dilution mix. This mixture is then passed into the hemoglobin module and hemoglobin levels are measured. The balance is then positioned at the entrance to the FOCUSED FLOW™ chamber for WBC analysis.
(3) A precisely measured portion of this mixture (50μL) is injected by the motorized syringe into the FOCUSED FLOW™ chamber and is analyzed for leukocolyte population. This chamber operates as follows: The chamber itself is tubular. In the middle, a funnelshaped passageway narrows and then opens to the original diameter (see diagram at Tab 5). Clean MULTI-CELL3 TM diluent is drawn into the instrument from the reagent box and injected under precisely controlled pressure at an angle into the wide end of the funnel so as to produce a circular, swirling action or vortex of clean "sheath" fluid spiraling into the narrow end of the funnel. At the same time, at the end of the chamber, diluent is extracted by a precisely controlled vacuum. Injection and vacuum pressure is created by the operation of two of the three precise, motorized syringes. The third syringe is then used to inject the blood sample mixture into the center of the vortex of sheath fluid, thus maintaining the physical integrity and characteristics of the blood cells. The swirling sheath fluid concentrates the blood sample in the center of the narrow end of the funnel which is the sensing zone. As individual blood cells pass into the sensing zone, the instrument generates multiple electronic signals around and through the blood cells. These are read by a transducer and recorded.
The reagents used in the mixture aid the multiple signals in determining cell size, cell membrane and intracellular composition. The reagents work in concert with the physiology of the cells' membranes. Cellular information is derived from the following sources: (1) the process of single cell analysis, (2) isometric pressures, (3) the absence of distorting shear forces on the cells, (4) the physiological "conditioning" of cell membranes, and (5) concomitant multiple signal generation and concomitant multiple signal acquisition.
The individual cellular information or data obtained in this way is processed by the computer using a patented mathematical algorithm named Expectation Maximization (EM). The mathematical algorithm is attached at Tab 6, and is also discussed in the Hazard Analysis attached at Tab 7. Results obtained by use of the analysis allows for differentiation of the reported parameters for WBC.
(4) Again by the operation of electronically controlled valves and the precise, motorized syringes, the reserved 10µL of the original stock dilution is separately mixed with reagents. The dilution is mixed by bubbling air through the measured reagent/blood sample mix, and is then positioned at the entrance of the FOCUSED FLOW™ chamber for RBC/Plt analysis.
(5) 25µL of this reagent-blood sample mixture is then injected by the motorized syringe into the FOCUSED FLOW™ chamber and is analyzed in a similar way to determine RBC/Plt composition. Again the reagents assist the multiple electronic signals to distinguish cell types and composition. The cell information is again processed using the parts of mathematical algorithm referencing red blood cell parameters attached at Tab 8.
(6) The system then cleans itself in preparation for reuse, and prompts the operator that it is ready with the message. "Ready" and "Mix Sample."
(7) The printer provides a report of 20 parameters on a high-resolution form. The report covers leukocytes and the five normal cell types (Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils). It produces "flags" for abnormal/immature cells. The report also includes a three-dimensional cytogram of the leukocyte population and a three-dimensional cytogram of the RBC/Plt population.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
peripheral human blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical Studies:
-
Study # 1:
Subjects: 215 excess patient recently drawn whole blood samples were selected from the whole blood samples available at Lawrence & Memorial Hospital clinical laboratories during the period of the study. Selection criteria was determined by the requirement that samples be selected in conformance with NCCLS H20-A. A distribution between abnormal and normal blood samples and a distribution among abnormalities was sought. Samples were initially analyzed on the Coulter STKS to determine distribution between abnormals and normals, and distribution among abnormalities.
Patient samples giving a morphologic positive result were eliminated from the white blood cell differential count portion of the correlation study, as recommended in NCCLS H20-A, resulting in a reduction of the samples for the WBC differential count portion only to 129.
Methodology: After a sample was selected, it was promptly analyzed by the MD 800 and the Coulter STKS and the results recorded. The clinical laboratory workers conducting the analysis the second time were not aware how a sample had been categorized in the first screening. Following NCCLS H20-A recommendations, the samples were run twice on the MD 800 and the average used in the correlations. Similarly, two technicians each did a WBC differential manual count on all samples, and their results were averaged for the purposes of the correlation. -
Study # 2 (Sensitivity study):
Subjects: The same 215 excess blood samples selected for Study #1 were used for this study. The initial selection criteria and methodology of selection for that study were therefore used for this study also. All 215 samples initially selected for study # 1 were included in this sensitivity study. The subset of flagged samples excluded from the Correlation Study were not excluded from this study, in conformance with the standards for a sensitivity study recommended by NCCLS H20-A.
Methodology: After a sample was selected, it was promptly analyzed in two separate runs by the MD 800 and the abnormalities indicated by the MD 800 as relevant flags were then recorded. Results for the same samples were also determined using a manual differential count. The clinical laboratory workers operating the MD 800 were not aware how a sample had been categorized in the first screening or in any other MD 800 run. The MD 800 records distributional abnormalities and morphological abnormalities. The distributional and morphological abnormalities as reported by the MD 800 were compared to the results obtained by the manual reference method in accordance with NCCLS H20-A. A false positive (FP) or false negative (FN) means that the manual count obtained a different result from the MD 800. The results from the MD 800, the Coulter STKS, and the manual WBC count were recorded. The manual count is recorded as the results from each technician, and the average of both. For the purposes of analysis and tabulation, the average of both technicians was used for the manual WBC count to minimize the effects of human error. -
Study # 3 (Field Use Study):
Subjects: 147 whole human blood samples. 57 samples at Norwalk Hospital, 40 samples at Lawrence & Memorial Hospital, and 50 samples at Children's Medical Hospital.
Methodology: The participating clinical laboratories were instructed to analyze excess fresh human blood samples according to the operating instructions for the MD 800 and for their regular automated hematology analyzer, following normal operating procedures for their laboratories, until they had each analyzed forty or more samples, and record the results for each over a period of days.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests:
Study Type: Precision (within run/short term; longterm stability; carryover) and Accuracy (linearity) studies.
Sample Size: Not specified, but generally refers to testing of the device performance with control materials.
Data Source: Clinical laboratory at Lawrence & Memorial Hospital in New London, Connecticut during 1997.
Key Results: The MD 800 performed within the normal and expected range for automated hematology instruments when so tested according to NCCLS H20-A.
Clinical Studies:
-
Study # 1 (Comparison Test):
Study Type: Correlation study comparing MD 800 to Coulter STKS and manual WBC differential count.
Sample Size: 215 excess patient whole blood samples initially; 129 samples for WBC differential count portion.
Data Source: Lawrence & Memorial Hospital clinical laboratories.
Key Results: The correlation coefficient, slope and y-intercept were determined for each parameter. The results obtained by the MD 800 are comparable to those obtained by the Coulter STKS, and the correlation coefficients for each parameter fall well within the accepted range for that parameter. The results obtained by the MD 800 and the manual WBC differential count likewise fall well within the accepted range for each parameter tested, and confirm both the comparable performance of the MD 800 and its safety and effectiveness. The resulting correlations fall well within the expected range. -
Study # 2 (Sensitivity Study):
Study Type: Sensitivity study
Sample Size: 215 excess patient blood samples (all 215 included in sensitivity study); 129 samples used in the distributional abnormality part.
Data Source: Lawrence & Memorial Hospital clinical laboratory.
Key Results: Out of 129 samples used in the distributional abnormality part of the study, there was one false negative and four false positives. Of 215 samples used in the morphological abnormality part of the study, there were two false negatives and 17 false positives. This sensitivity study obtained results well within the expected range for automated hematological blood analyzers. The CDC MD 800's sensitivity results for the distributional abnormalities gave a more favorable false negative ratio (2.27%) versus the Coulter STKS (7.5%). The CDC MD 800 sensitivity results for the morphological abnormalities gave a more favorable false negative (2.86%) versus the Coulter STKS (10.0%). A low false negative ratio assists clinicians in not missing an abnormality. The low incidence (less than 3%) of false negatives is particularly significant. -
Study # 3 (Field Use Study):
Study Type: Clinical study at multiple sites
Sample Size: 147 whole human blood samples (57 at Norwalk Hospital, 40 at Lawrence & Memorial Hospital, and 50 at Children's Medical Hospital).
Data Source: Norwalk General Hospital, Norwalk, Connecticut; Lawrence & Memorial Hospital, New London, Connecticut; Children's Medical Associates, P.C., Ansonia, Connecticut.
Key Results: Correlation coefficients obtained at each site are very similar to the correlation coefficients obtained in the comparison study... All of the directly measured parameters at each site have a very high correlation (.90 or higher). Most of the indices likewise have a correlation of .90 or higher. MCHC, MCH and MPV have lower coefficients, but those results are consistent with the same level of correlation obtained in the comparative precision, accuracy and sensitivity tests conducted on the MD 800 and Coulter STKS, and fall within the normal range of correlation expected for hematology analyzers for those parameters. The correlation coefficients fall well within the normal range expected under conditions of field use in hospitals or point of use.
Overall conclusion: Based on these data, the MASCOT Hematology Analyzer is as safe and effective and performs as well or better than the predicate device for the intended use of obtaining an in vitro, 20 parameter hematological profile of whole peripheral blood in clinical laboratories.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (False Negative Ratio):
Study #2 (Distributional abnormalities): MD 800: 2.27%, Coulter STKS: 7.5%
Study #2 (Morphological abnormalities): MD 800: 2.86%, Coulter STKS: 10.0%
False Positives:
Study #2 (Distributional abnormalities): 4 false positives out of 129 samples
Study #2 (Morphological abnormalities): 17 false positives out of 215 samples
Correlation Coefficients:
Study #1: For each parameter, correlation coefficients fall well within the accepted range.
Study #3: Directly measured parameters: .90 or higher. Most indices: .90 or higher. MCHC, MCH, MPV: lower coefficients, but within normal range for hematology analyzers.
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.”
0
K9815208
AUG 21 1998
510(k) SUMMARY
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided pursuant to 21 C.F.R. § 807.92.
Submitter's name, address, telephone number, contact person, and date on which summary was prepared.
CDC Technologies, Inc. One Great Hill Road Oxford, CT 06478 (203) 888-2323 FAX: (203) 888-4828
Contact: David C. DeCava, V.P. of Operations
Date Prepared: April 30, 1998
Device name: trade or proprietary name and common or usual name.
Common Name: Automated Differential Blood Cell Counter
Proprietary Name: MASCOT MD Hematology Analyzer Model MD 800
Identification of the legally marketed device to which the submitter claims substantial equivalence.
Coulter Model STKS Manufactured by Coulter Electronics, Inc. 501(k) No. K885093
Description of the MD 800
Description:
In General. 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.
Components. The MD 800 consists of five components:
(1) A blood analysis instrument (the "instrument") with external cord and grounded
1
plug for connection to a standard 110V AC outlet.
Externally, this instrument has an external diluter probe for the intake of blood samples and a communications panel consisting of red and green LED lights, a communications screen which provides messages to prompt the operator, and a keypad for operator input.
Internally, the instrument in general consists of three precise, motorized syringes used to move the blood sample, a series of electronically controlled valves which direct its flow, cuvette used to mix reagents with measured quantities of the sample, a transducer chamber used to count the blood cells, another transducer chamber used to determine hemoglobin levels, connective tubing and wiring, the communications panel described above and a computer and related software program used to direct the instrument in taking a series of steps necessary to analyze the sample and produce a report.
(2) A reagent dispensing unit connected to the instrument by tubes and four reagents (described below in "Reagents") used in it.
(3) Calibration and control reagents consisting of a reagent used to calibrate the MD 800 as directed in the Manual and another reagent used according to good laboratory practices at the beginning and end of each group of samples, or in long runs, at established intervals to verify operation of the instrument (these reagents are described below in "Reagents").
(4) Probeclenz™, a cleaning liquid described below in Reagents.
(5) A standard, off-the-shelf high resolution printer selected by the manufacturer to print the report of the analysis.
Reported Parameters. 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% |
2
| 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 % |
Reagents. The MD 800 uses the following reagents:
(1) diluent: MULTI-CELL3, an azide-free isotonic electrolyte for diluting the blood sample, stabilizing the cell membranes, and conducting current in the sensing zone. The diluent maintains the integrity of the erythrocytes, leukocytes, and platelets;
(2) lytic reagents: CELLYSE XIH™ and CELLYSE XIIH™, which are azide-free lytic reagents that (a) lyse erythrocytes, freeing hemoglobin from the lysed red blood cells and converting a substantial portion of it to a stable, cyanide-containing pigment, (b) reduce the size of cellular debris to avoid interference with leukocyte counts, and (c) slightly alter the WBC membranes to allow differentiating measurements to be made. The leukocyte membranes are physically maintained so as not to leave a bare nucleus;
(3) cleaning agents: CD CLEAN™, a deproteinizer included in the reagent kit which prevents protein build up in the system; and PROBECLENZ™, a cleaning liquid used according to instructions in the Operators Manual (pages 4-4, 4-6 and 8-2) used periodically to clean the instrument.
(4) control material: TECH-TROL™, used at three levels, to monitor both the CBC and WBC differential parameters; and
(5) calibrator: MD CAL-KIT™, which is used to calibrate the CBC parameters.
How the MD 800 functions:
After calibration and initial testing, the operator mixes a sample of EDTA-treated human blood, and causes the MD800 to aspirate a 20 uL samaple of the blood sample into the instrument. After a few additional short steps, the instrument automatically performs all remaining functions necessary to complete the analysis of the blood sample. The operator has no other function except appropriate handling of the printed report. An analysis of a blood sample takes approximately 5 minutes.
Following a sequence of steps, the MD 800 creates both a red blood cell ("RBC") dilution and a white blood cell ("WBC") dilution using the HEMA-SET" reagents described below and then analyses the resulting dilutions. The steps are as follows:
3
(1) The instrument creates a stock dilution by drawing precise quantities of specific reagents (described below in "Reagents") from the reagent box and mixes them with 20 uL of whole blood sample by opening valves and the operation of the motorized syringes. The sample is mixed by bubbling air through the measured reagent/blood sample mix. 10 uL of the stock dilution is reaspirated into the aspirator probe and reserved for the RBC/Plt analvsis.
(2) To determine WBC and hemoglobin, the instrument again draws precise quantities of specific reagents from the reagent box and mixes them with the remaining stock dilution. This dilution is again mixed by bubbling air through the reagent/blood stock dilution mix. This mixture is then passed into the hemoglobin module and hemoglobin levels are measured. The balance is then positioned at the entrance to the FOCUSED FLOW™ chamber for WBC analysis.
(3) A precisely measured portion of this mixture (50μL) is injected by the motorized syringe into the FOCUSED FLOW™ chamber and is analyzed for leukocolyte population. This chamber operates as follows: The chamber itself is tubular. In the middle, a funnelshaped passageway narrows and then opens to the original diameter (see diagram at Tab 5). Clean MULTI-CELL3 TM diluent is drawn into the instrument from the reagent box and injected under precisely controlled pressure at an angle into the wide end of the funnel so as to produce a circular, swirling action or vortex of clean "sheath" fluid spiraling into the narrow end of the funnel. At the same time, at the end of the chamber, diluent is extracted by a precisely controlled vacuum. Injection and vacuum pressure is created by the operation of two of the three precise, motorized syringes. The third syringe is then used to inject the blood sample mixture into the center of the vortex of sheath fluid, thus maintaining the physical integrity and characteristics of the blood cells. The swirling sheath fluid concentrates the blood sample in the center of the narrow end of the funnel which is the sensing zone. As individual blood cells pass into the sensing zone, the instrument generates multiple electronic signals around and through the blood cells. These are read by a transducer and recorded.
The reagents used in the mixture aid the multiple signals in determining cell size, cell membrane and intracellular composition. The reagents work in concert with the physiology of the cells' membranes. Cellular information is derived from the following sources: (1) the process of single cell analysis, (2) isometric pressures, (3) the absence of distorting shear forces on the cells, (4) the physiological "conditioning" of cell membranes, and (5) concomitant multiple signal generation and concomitant multiple signal acquisition.
The individual cellular information or data obtained in this way is processed by the computer using a patented mathematical algorithm named Expectation Maximization (EM). The mathematical algorithm is attached at Tab 6, and is also discussed in the Hazard Analysis attached at Tab 7. Results obtained by use of the analysis allows for differentiation of the reported parameters for WBC.
-4-
4
The chamber is then flushed and prepared for the next sample.
(4) Again by the operation of electronically controlled valves and the precise, motorized syringes, the reserved 10µL of the original stock dilution is separately mixed with reagents. The dilution is mixed by bubbling air through the measured reagent/blood sample mix, and is then positioned at the entrance of the FOCUSED FLOW™ chamber for RBC/Plt analysis.
(5) 25µL of this reagent-blood sample mixture is then injected by the motorized syringe into the FOCUSED FLOW™ chamber and is analyzed in a similar way to determine RBC/Plt composition. Again the reagents assist the multiple electronic signals to distinguish cell types and composition. The cell information is again processed using the parts of mathematical algorithm referencing red blood cell parameters attached at Tab 8.
(6) The system then cleans itself in preparation for reuse, and prompts the operator that it is ready with the message. "Ready" and "Mix Sample."
(7) The printer provides a report of 20 parameters on a high-resolution form. The report covers leukocytes and the five normal cell types (Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils). It produces "flags" for abnormal/immature cells. The report also includes a three-dimensional cytogram of the leukocyte population and a three-dimensional cytogram of the RBC/Plt population.
Scientific Concepts:
Each of the parameters is measured by the MD800 based on the following scientific principles:
| WBC, RBC, Plt: | Cells are guided through a patented Focused Flow micro-
aperture where they are counted according to impedance
variation. |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hgb: | A cyanide-containing pigment is measured by
spectrophotometry through the optical part of the WBC
device at a wavelength of 540 nm ± 1 nm. |
| MCV: | An electronic device measures the pulse heights
generated by the passage of RBCs through the Focused
Flow chamber. The stored values of the pulse heights
(which are proportional to the volume of the individual
RBCs) are sorted into a pulse height distribution the
mean of which is proportional to the MCV. |
| Hct, MCH, MCHC: | These parameters are calculated from other measured |
-5-
5
parameters.
| RDW: | This parameter is a coefficient of variation of the RBC
distribution as a percent of average RBC size. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MPV: | This parameter is derived from the accumulation of
platelet data within the platelet population distribution. |
| LY, MO, NE, EO, BA: | The leukocyte differential counts are obtained from
volume and intracellular complexity measurements and
processed according to a patented mathematical algorithm
termed Expectation Maximization. |
Significant Performance Characteristics of Device:
The performance specifications of the MD 800 are shown at Figure 6-1
Statement of intended use.
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% |
6
FIGURE 6-1
MASCOT ™ MD 800 HEMATOLOGY SYSTEM SPECIFICATIONS
| DESCRIPTION | MD 800 SPECIFICATIONS | |
|---|---|---|
| Parameters: | ||
| Leukocytes: | WBC, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA# | |
| Erythrocytes: | RBC, Hb, HCT, MCV, MCH, MCHC, RDW | |
| Platelets: | PLT, MPV | |
| Cytograms: | Exclusive 3-D Displays of WBC Subpopulations, RBC/Platelet Populations | |
| Sample Volume: | 20µL | |
| Throughput: | 12 Specimens per Hour | |
| Data Input/Output: | Touch Keypad, LCD Display, Customized 8.5" x 11" High-Resolution Report | |
| with Exclusive 3-D WBC, RBC, and PLT Cytograms | ||
| Optional Output: | Internal Data Storage. RS232 Port for External Computer Interface | |
| Flagging: | Automatic Distributional and Morphological Flagging, Hematologic | |
| Abnormality Charts | ||
| Power Requirements: | 47 - 63 Hz, 95 - 132 vAC, |