UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System

K240252 · Beckman Coulter, Inc. · GKZ · Jul 5, 2024 · Hematology

Device Facts

• Record ID: K240252
• Device Name: UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
• Applicant: Beckman Coulter, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Jul 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The UniCel DxH 900/DxH 690T Coulter Cellular Analysis System is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 900/DxH 690T hematology analyzer identifies and enumerates the following parameters: - Whole Blood (Venous or Capillary): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF - Pre-Diluted Whole Blood (Venous or Capillary): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV - Body Fluids (cerebrospinal, serous or synovial): TNC and RBC The UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

Device Story

System comprises automated hematology analyzers (DxH 900/690T) and automated slide maker/stainer (DxH SMS II). Analyzers use Coulter Principle (aperture impedance) for cell counting/sizing and VCSn technology (DC impedance, RF conductivity, laser light scatter/absorbance) for WBC differential, NRBC, and reticulocyte analysis. Input: whole blood (venous/capillary) or body fluids. Process: sample aspiration, reagent mixing, automated analysis, and data reporting. SMS II automates blood film preparation and staining using robotic slide handling and wedge smear technique. Used in clinical laboratories by trained personnel. Output: quantitative hematology parameters, histograms, and stained slides for microscopic review. Results assist clinicians in determining patient hematologic status.

Clinical Evidence

Method comparison study (N=735 venous samples, N=204 body fluid samples) compared subject device to predicate. Passing-Bablok regression showed high correlation (r=0.999-1.000 for major parameters). Sensitivity/specificity study (N=735) evaluated flagging capabilities; morphological abnormalities showed 88.5% PPA and 95.5% NPA; distributional studies showed 95.0% PPA and 88.1% NPA. Reference ranges verified per CLSI EP28-A3c. Bench testing included precision, linearity, LoB/LoD/LoQ, and carry-over, all meeting predefined acceptance criteria.

Technological Characteristics

Multi-parameter automated hematology analyzer. Sensing: Aperture impedance (DC) for cell counting/sizing; VCSn technology (Volume, Conductivity, laser light scatter, axial light loss) for differential. Energy: Electrical. Connectivity: Networked/LIS integration. Software: Embedded application and workstation-based system manager. Sterilization: N/A (in vitro diagnostic). Materials: Standard laboratory instrument components (metal/plastic).

Indications for Use

Indicated for in vitro diagnostic screening of patient populations in clinical laboratories to provide complete blood counts (CBC), leukocyte 5-part differentials, reticulocyte counts, nucleated red blood cell (NRBC) counts on whole blood, and total nucleated counts (TNC) and RBC counts on body fluids (cerebrospinal, serous, synovial).

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application (K193124)
• UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System (K162414)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract image of a human figure, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size than the rest of the text.

July 5, 2024

Beckman Coulter, Inc Marie Steigerwalt Staff Regulatory Affairs Specialist 11800 S.W. 147th Avenue Miami, Florida 33196

#### Re: K240252

Trade/Device Name: UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: June 3, 2024 Received: June 4, 2024

Dear Marie Steigerwalt:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Digitally signed by YAN CAI -S
YAN CAI -S Date: 2024.07.05 13:46:27
-04'00'

for

Min Wu Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K240252

Device Name UniCel DxH 900 Coulter Cellular Analysis System ;

UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System

Indications for Use (Describe)

The UniCel DxH 900/DxH 690T Coulter Cellular Analysis System is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The DxH 900/DxH 690T analyzer identifies and enumerates the following parameters:

· Whole Blood (Venous or Capillary): WBC, RBC, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO%, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF · Pre-Diluted Whole Blood (Venous or Capillary): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV

· Body Fluids (cerebrospinal, serous or synovial): TNC and RBC

The UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

Type of Use (Select one or both, as applicable)

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## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K240252.

### 807.92 (a)(1): Contact Details

Name: Beckman Coulter, Inc Address: 11800 S.W. 147th Avenue Miami FL 33196 United States Phone: [phone] Email: [e-mail] Contact: Marie Steigerwalt

### 807.92 (a)(2): Device Name

### Trade Name:

UniCel DxH 900 Coulter Cellular Analysis System UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System UniCel DxH 690T Coulter Cellular Analysis System Common Name: Automated differential cell counter Classification Name: Counter, Differential Cell Regulation Number: 21 CFR 864.5220 Product Code(s): GKZ

#### 807.92 (a)(3): Identification of the Legally Marketed Predicate Devices

| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|-------------|--------------------------------------------------------------------------------------------|--------------|
| K193124 | UniCel DxH 800 Coulter Cellular Analysis System with Early<br>Sepsis Indicator Application | GKZ |
| K162414 | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System | GKZ |

## 807.92 (a)(4): Device Description Summary

The UniCel DxH 900/DxH 690T System contains an automated hematology analyzer (DxH 900 or DxH 690T) designed for in vitro diagnostic use in screening patient populations by clinical laboratories. The system provides a Complete Blood Count (CBC), Leukocyte 5-Part Differential (Diff), Reticulocyte (Retic), Nucleated Red Blood Cell (NRBC) on whole blood, as well as, Total Nucleated Count (TNC), and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).

The DxH Slidemaker Stainer II is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

The DxH 900 System may consist of a workcell (multiple connected DxH 900 instruments with or without a DxH Slidemaker Stainer II), a stand-alone DxH 900, or a stand-alone DxH Slidemaker Stainer II. The DxH 690T System consists of a stand-alone DxH 690T instrument. The available DxH 900 workcell systems are listed in the table below.

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## DxH 900, DxH 690T and DxH Slidemaker Stainer II Stand-alone Instruments, and DxH 900 and DxH Slidemaker Stainer II Workcell Configurations

| Configuration | Topologies | | | System Manager | Review Stations | |
|---------------------------------|---------------------------|---------|---------|-------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DxH 900 | DxH 900 | | | Standard Computer | N/A | |
| DxH 690T | DxH 690T | | | Standard Computer | N/A | |
| DxH<br>Slidemaker<br>Stainer II | DxH Slidemaker Stainer II | | | Standard Computer | N/A | |
| DxH 900 S | DxH Slidemaker Stainer II | DxH 900 | | Standard Computer | Optional Stand-alone<br>Review Station with<br>Standard Computer | |
| DxH 900-2 | DxH 900 | DxH 900 | | Power Computer | Power Computer | |
| DxH 900-2 S | DxH Slidemaker Stainer II | DxH 900 | DxH 900 | Power Computer | One Review Station<br>required with a<br>Power Computer.<br>Optional Review<br>Station with<br>Standard Computer | |
| DxH 900-3 | DxH 900 | DxH 900 | DxH 900 | Power Computer | Two Review Stations<br>required, one with<br>Power Computer and<br>one with Standard<br>Computer | |
| DxH 900-3 S | DxH Slidemaker Stainer II | DxH 900 | DxH 900 | DxH 900 | Power Computer | Two Review Stations<br>required, one with<br>Power Computer and<br>one with Standard<br>Computer. Optional<br>Stand-alone<br>Workstation with<br>Standard Computer |

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## Principle of Operation:

The Coulter Principle is used to count and size cells by detecting and measuring changes in electrical resistance when a particle (such as a cell), in a conductive liquid, passes through a small aperture as shown in Figure 1.

Figure 1: Coulter Principle

Image /page/5/Figure/3 description: The image shows a diagram of a blood cell counter. The diagram includes labels for different parts of the counter, including the aperture current (1), vacuum (2), internal electrode (3), blood cell suspension (4), detail of aperture (5), aperture tube (6), aperture (7), sample beaker (8), and external electrode (9). The diagram provides a visual representation of the components and their arrangement within the blood cell counter.

Each cell, suspended in a conductive liquid (diluent), acts as an insulator. As each cell goes through the aperture, it momentarily increases the resistance of the electrical path between two submerged electrodes on either side of the aperture. This causes a measurable electronic pulse. For counting, the vacuum used to pull the diluted suspension of cells through the aperture must be at a regulated volume. While the number of pulses indicates particle count, the size of the electrical pulse is proportional to the cell volume.

The lytic reagent used for the WBC prepares the blood so the system can count leukocytes and measure the amount of hemoglobin. The lytic reagent rapidly and simultaneously destroys the erythrocytes and converts a substantial proportion of the hemoglobin to a stable pigment while it leaves leukocyte nuclei intact. The absorbance of the pigment is directly proportional to the hemoglobin concentration of the sample. Hemoglobin is measured photometrically at 525 nm using the sample from the WBC analysis. Clean diluent is introduced into the cuvette during each operating cycle and is used as a blank in the calculation of the HGB.

The COULTER VCS technology is used to determine the white cell differential, nucleated red blood cell and reticulocyte parameters along with associated flags, messages, histograms and

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data plots. As the particles pass through the sensing zone, a diode laser illuminates the particles. The flow cell measures volume, conductivity, multiple angles of light scatter, and axial light loss.

- . For the WBC differential, sample preparation occurs at the Diff mix chamber where sample and reagents are added in the following order: Diff Lyse, blood, additional Diff Lyse followed by an air mix. Next, Diff preservative is added, followed by a second air mix, and an incubation period. The prepared sample is transferred to the module where cells are counted in an isometric sample stream. The algorithm analysis separates the WBC into five major populations.
- . For NRBC, sample preparation occurs at the NRBC Diff mix chamber where sample and reagents are added in the following order: Diluent, blood, additional Diluent followed by an air mix. Next, DxH Cell Lyse is added, followed by a second air mix, and an incubation period. The prepared sample is transferred to the module where cells are counted in an isometric sample stream. The algorithm analysis separates NRBC from WBC.
- Reticulocytes are immature, non-nucleated erythrocytes retaining a small network of . basophilic organelles, consisting of RNA and protoporphyrin. The enumeration of reticulocytes provides a simple, effective means to determine red cell production and regeneration. Reticulocyte immaturity is related to cell volume and light scatter. Since more immature reticulocytes are larger, contain more RNA and cause increased light scatter, the cell volume and light scatter will increase with immaturity of the cell.

The DxH Slidemaker Stainer II allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer II are moved to baskets for transfer to the Stainer portion by a robot. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient.

The aspiration probe aspirates the mixed sample, which is transported into the dispense probe. The probe moves to the drop placement position where blood is placed on the slide. A second slide is picked up and used to spread the drop on the first slide using the wedge technique. The prepared slide is transferred into the print shuttle where Information is thermally printed on the painted portion of the slide, and then into the basket elevator for drying. The dispense probe is cleaned in the dispense wash cup after drop placement on the slide.

For staining, the slide basket is dipped into each bath (1 to 5) for a staining time according to the active protocol. Each bath is configured to receive reagent from a predetermined supply source configured by the user. Slides are dried after staining.

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### 807.92 (a)(5): Intended Use

The UniCel DxH 900/DxH 690T Coulter Cellular Analysis System is a quantitative, multiparameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The DxH 900/DxH 690T analyzer identifies and enumerates the following parameters:

· Whole Blood (Venous or Capillary); WBC. RBC. HGB. HCT. MCV. MCH. MCHC. RDW. RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF

· Pre-Diluted Whole Blood (Venous or Capillary): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV

· Body Fluids (cerebrospinal, serous or synovial): TNC and RBC

The UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

### 807.92 (a)(5): Indications for Use Comparison

The UniCel DxH 900 Coulter Cellular Analysis System. UniCel DxH 690T Coulter Cellular Analysis System, and UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System are substantially equivalent to the UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System cleared under the 510(k) numbers K193124 and K162414. There are no changes to the intended use or claims.

## 807.92 (a)(6): Technological Comparison

The UniCel DxH 900 Coulter Cellular Analysis System. UniCel DxH 690T Coulter Cellular Analysis System, and UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System have the same technological characteristics (principal of operation, energy source, reagents, calibrators, controls, and packaging) as the predicate devices.

| Characteristic | Predicate DxH 800<br>K193124 | Subject DxH 900/690T System |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Analyzer:<br>The UniCel DxH 800 Coulter Cellular Analysis System<br>is a quantitative, multi-parameter, automated<br>hematology analyzer for <i>in vitro</i> diagnostic use in<br>screening patient populations found in clinical<br>laboratories.<br><br>The DxH 800 hematology analyzer identifies and<br>enumerates the following parameters:<br>• Whole Blood (Venous or Capillary): WBC, RBC,<br>HGB, HCT, MCV, MCH, MCHC, RDW, RDW-<br>SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%,<br>MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#,<br>RET%, RET#, MRV, IRF<br>• Pre-Diluted Whole Blood (Venous or Capillary):<br>WBC, RBC, HGB, HCT, MCV, MCH, MCHC,<br>RDW, RDW-SD, PLT, MPV | Same |
| Characteristic | Predicate DxH 800<br>K193124 | Subject DxH 900/690T System |
| | • Body Fluids (cerebrospinal, serous or synovial): TNC<br>and RBC | |
| Sampling Mechanism | Single aspiration probe used for all sampling.<br>Single tube presentation - open and closed vial<br>sampling - specimen manually mixed.<br>Automated presentation – closed vial sampling from<br>five-position cassette accepting a variety of defined<br>specimen tubes. Cassette containing specimens mixed<br>prior to starting sampling and between specimens.<br>Maximum initial load capacity 20 cassettes - System<br>will continuously process racks as added. | Same |
| Principles of<br>Measurement | WBC, RBC, MCV, PLT: Aperture impedance (Coulter®<br>Principle)<br>Hemoglobin: Spectrophotometric<br>WBC Differential, Reticulocytes, NRBC:<br>VCSn Technology using:<br>• Aperture impedance (DC)<br>• Conductivity (RF)<br>• Laser Light Scatter (Multiple angles)<br>• Laser Light Absorbance | Same |
| Consumables | Analysis Reagents<br>• COULTER DxH Diluent<br>• COULTER DxH Diff Pack<br>• COULTER DxH Cell Lyse<br>• COULTER DxH Retic Pack<br>• COULTER DxH Cleaner<br>Quality Control & Calibrators<br>• COULTER 6C Cell Control<br>• COULTER 6C Plus Cell Control<br>• COULTER Latron CP-X Control<br>• COULTER RETIC-X Cell Control<br>• COULTER LIN-X Control<br>• COULTER Body Fluids Control<br>• COULTER S-CAL Calibrator kit | Same, plus the option of the following<br>ECO reagents:<br>• DxH ECO Diluent (RTU)<br>• DxH Concentrated ECO<br>Diluent (18x)<br>• DxH ECO Cell Lyse |
| Pre-Analytic Features | | |
| System<br>configuration | PC based workstation running Microsoft Windows 7<br>application specific software Handheld Barcode Scanner<br>Printer | Same, but Windows 10 |
| Sampling<br>Mechanism | Single tube presentation - open and closed vial<br>sampling.<br>Automated presentation - closed vial sampling from 5<br>position cassette; Maximum initial load capacity 20<br>racks | Same |
| Mechanisms for<br>processing | Mechanisms to achieve process of:<br>Automated cassette transportation and specimen mixing<br>(by rocking), sample aspiration, sample preparation,<br>sample and reagent presentation to analytical modules,<br>sample analysis, raw data collection, algorithmic<br>processing and data reporting. | Same |
| Characteristic | Predicate DxH 800<br>K193124 | Subject DxH 900/690T System |
| | allowing multi-directional moves and capability to<br>return cassette to sampling position for repeat / reflex<br>testing. | |
| Sample Identification | Sample aspiration module (SAM) mounted barcode<br>reader for automated barcode reading of cassette<br>and sample tube identifiers. Manual barcode scanning of sample tube identifier<br>(handheld scanner) Manual keyboard entry of sample identifier | Same |
| Sample Processing | | |
| Aspiration Pathway | Single sampling probe and common aspiration pathway<br>used for all sample presentation modes. | Same |
| Sample Aspiration<br>Volume | Automatic, cap-piercing: 165 µL<br>Single tube - open-vial and cap pierce:165 µL<br>Pre-dilute 165 µL - fixed ratio of 1 in 5 dilution of blood<br>with diluent | Same |
| Throughput | For automatic mode:<br>CBC at 100 specimens/hr CBC and Differential at 100 specimens/hr CBC and Differential with NRBC at 90<br>specimens/hr Retic at 45 specimens/hr | Same |
| Data Reporting | Workstation display graphics, hardcopy printing and<br>transmission to Laboratory Information System (LIS) | Same |
| System Control and Software | | |
| System Software | System software (embedded and workstation) designed<br>specific to support all features of the DxH 800. The<br>software system consists of a Data Manager component,<br>a Universal System Manager component (including<br>algorithms), the User Interface, all of which are resident<br>in the system software in the workstation.<br>In addition, an Embedded Application is resident in the<br>analyzer. The Embedded application uploads from the<br>workstation on system power-up. Extensive real time<br>monitoring and reporting of system status including:<br>Component and module activities, System Voltages and Currents System Pressure and Vacuum System Temperatures Motor activity Mechanism Sensor status Reagent Pump Operation Raw data collection Single sampling probe and common aspiration pathway<br>used for all sample presentation modes. | Same system software with<br>enhancements to the instrument look<br>and feel, workflow, usability, quality<br>control and reliability. |
| Characteristic | Predicate DxH SMS<br>K162414 | Subject SMS II |
| Intended Use | The DxH Slidemaker Stainer is a fully automated slide<br>preparation and staining device that aspirates a whole-<br>blood sample, smears a blood film on a clean<br>microscope slide, and delivers a variety of fixatives,<br>stains, buffers, and rinse solutions to that blood smear. | Same |
| Characteristic | Predicate DxH 800<br>K193124 | Subject DxH 900/690T System |
| Specimen Collection | Whole venous blood in EDTA | Same |
| Blood Film<br>Preparation | Automatically prepared by DxH SMS | Same |
| Blood Film<br>Requirements | Section 6.3.1 of CLSI H20-A2 | Same |
| Consumables | Stains and Buffers: Beckman Coulter TruColor<br>Reagents for use on the DxH Slidemaker Stainer<br><br>• TruColor Wright Stain and TruColor Wright Buffer<br>• TruColor Wright-Giemsa Stain and TruColor Wright-Giemsa Buffer<br><br>Coulter TruColor Giemsa and May Grunwald Stains are<br>not validated by Beckman Coulter for use through<br>current default protocols on the system.<br><br>Fixative: Methanol is used as a fixative for whole-blood<br>smears in preparation for staining. Anhydrous methanol<br>(chromatography grade, 99.8% or higher quality) is<br>recommended.<br><br>Distilled Water: Distilled water is used to rinse the<br>stained smears before drying. CLSI Type CLRW water<br>is recommended. | Same |

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

## 807.92 (b): Non-Clinical and/or Clinical Test Summary

- a) Specimen Sampling Positions Comparability was tested on the DxH 800 (predicate) per EP09c, CLSI H26-A2, and CLSI H56 to establish equivalency for all sampling modes (Single tube open vial, Single tube closed vial, and Cassette presentations). Due to the similarities in the instrument hardware, data presented in K120771 continues to support the use of all specimen sampling positions as appropriate for the intended use of the device.

| Test Panel | Reported Parameters | Specimen Type | Sampling Method |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------------------------------------------------------------------------------------------------|
| Complete Blood<br>Count (CBC) | • WBC, RBC, HGB, HCT, MCV,<br>MCH, MCHC, RDW, RDW-SD,<br>PLT, MPV | whole blood | • Automated cassette closed vial<br>• Manual single tube closed vial<br>• Manual single tube open vial |
| CBC and<br>Differential inc<br>NRBC<br>(CD) | • WBC, RBC, HGB, HCT, MCV,<br>MCH, MCHC, RDW, RDW-SD,<br>PLT, MPV<br>• NE%, NE#, LY%, ly#, MO%, MO#,<br>EO%, EO#, BA%, BA#, NRBC%,<br>and NRBC# | whole blood | • Automated cassette closed vial<br>• Manual single tube closed vial<br>• Manual single tube open vial |
| CBC, Differential<br>inc NRBC and<br>Retic<br>(CDR) | • WBC, RBC, HGB, HCT, MCV,<br>MCH, MCHC, RDW, RDW-SD,<br>PLT, MPV<br>• NE%, NE#, LY%, ly#, MO%, MO#, MO#,<br>EO%, EO#, BA%, BA#, NRBC%,<br>and NRBC#<br>• RET%, RET#, MRVM IRF | whole blood | • Automated cassette closed vial<br>• Manual single tube closed vial<br>• Manual single tube open vial |
| CBC and Retic<br>(CR) | • WBC, RBC, HGB, HCT, MCV,<br>MCH, MCHC, RDW, RDW-SD,<br>PLT, MPV<br>• RET%, RET#, MRVM IRF | whole blood | • Automated cassette closed vial<br>• Manual single tube closed vial<br>• Manual single tube open vial |
| Retic<br>(R) | • RET%, RET#, MRVM IRF | whole blood | • Automated cassette closed vial<br>• Manual single tube closed vial<br>• Manual single tube open vial |

{11}------------------------------------------------

| Test Panel | Reported Parameters | Specimen Type | Sampling Method |
|--------------------------|-------------------------------------------------------------------|-------------------------------------------------------|--------------------------------|
| Pre-dilute<br>(PreDilx5) | • WBC, RBC, HGB, HCT, MCV,<br>MCH, MCHC, RDW, RDW-SD,<br>PLT, MPV | 1 in 5 pre-diluted<br>whole blood | • Manual single tube open vial |
| Body Fluid<br>(BF) | • TNC, RBC | body fluid<br>(cerebrospinal, serous<br>and synovial) | • Manual single tube open vial |

- b) Whole blood and body fluid repeatability precision was tested on the DxH 900-3S workcell (instruments BC03127, BC03129, and BC03130) using the instrument's repeatability mode using cassette presentation for whole blood and single-tube presentation sampling for body fluids. Testing was performed according to CLSI H26-A2 and CLSI EP05-A3 to demonstrate the precision of the DxH 900 using whole blood and body fluid specimens. The whole blood and body fluid precision data provided supports the precision claims in the instructions for use. Connection of instruments into a workcell configuration does not significantly impact the precision.
Within run Repeatability of the parameters was performed using ten (10) aspirations of normal whole blood samples collected in K2EDTA. Specimens were selected for testing based on parameter value within specific ranges per parameter (measurand) to cover across the analytical measuring interval (AMI). Within run Imprecision (repeatability) was tested by performing replicate analysis of the specimens selected using the Repeatability function. Targeted specimens were used for more than one measurand. The coverage of the other measurand's measuring ranges was dependent on the spread of the samples collected to cover the measuring interval of the measurands. If normal and clinical specimens in the intended use populations were not found for estimation of precision profiles, contrived samples and control material were used.

Abnormal patient samples with low NRBC (1.00 - 2.00, >2.00 - 15.00), high NRBC (>15.00), and high Reticulocytes (>4.000 - 15.0) were not available during the test period. Instead, control material was used to assess Repeatability for these parameter values. Also, low levels for WBC 0.500 - 2.000 x103 cells/uL, Platelet 10.0 - 15.0 x103 cells/μL, Body fluid RBC 10,000 - 15,000 cells/mm3 and TNC 50-2,000 cells/mm3 were performed using altered whole blood samples due to no donor availability during the testing period as well.

| Parameter | Units | Level | N | Test Result Mean | Test Result %CV or<br>SD | Acceptance |
|-----------|---------------|----------------|----|------------------|--------------------------|------------|
| WBC | x103 cells/µL | 5.000 - 10.000 | 10 | 5.80 | 0.69% CV | Pass |
| WBC | x103 cells/µL | 0.500 to 2.000 | 10 | 0.59 | 2.02% CV | Pass |
| RBC | x106 cells/µL | 4.500 - 5.500 | 10 | 4.72 | 0.50% CV | Pass |
| Hgb | g/dL | 14.00 - 16.00 | 10 | 15.03 | 0.36% CV | Pass |
| MCV | fL | 80.00 - 90.00 | 10 | 85.39 | 0.22% CV | Pass |
| RDW % | % | 12.00 - 14.00 | 10 | 13.71 | 1.31% CV | Pass |
| RDW-SD | fL | 33.00 - 48.00 | 10 | 47.03 | 1.82% CV | Pass |
| Platelet | x103 cells/µL | 200.0 - 400.0 | 10 | 256.80 | 1.35% CV | Pass |
| Platelet | x103 cells/µL | 10.0 to 15.0 | 10 | 12.90 | 2.60% CV | Pass |
| MPV | fL | 8.0 - 10.0 | 10 | 8.13 | 1.15% CV | Pass |
| Neut % | % | 50.0 - 60.0 | 10 | 58.24 | 0.99 %CV | Pass |
| Lymph % | % | 25.0- 35.0 | 10 | 26.34 | 2.44% CV | Pass |
| Mono % | % | 5.0 - 10.0 | 10 | 6.22 | 7.66 % CV | Pass |

#### Repeatability Results- Whole Blood CBC, DIFF, Retic

{12}------------------------------------------------

| Parameter | Units | Level | N | Test Result Mean | Test Result %CV or SD | Acceptance |
|-----------|-------|------------------|-----|------------------|-----------------------|------------|
| Eos % | % | 2.0 - 5.0 | 10 | 2.21 | 5.06% CV | Pass |
| Baso % | % | 0.5 - 1.5 | 10 | 1.22 | 0.13 SD | Pass |
| NRBC | % | 1.00 - 2.00 | 10* | 1.46 | 0.20 SD | Pass |
| NRBC | % | >2.00 - 15.00 | 10* | 9.21 | 4.69% CV | Pass |
| NRBC | % | > 15.00 | 10* | 19.12 | 5.12% CV | Pass |
| Retic % | % | 0.000 - 1.500 | 10 | 1.17 | 0.13 SD | Pass |
| Retic % | % | > 1.500 - 4.000 | 10 | 1.52 | 0.09 SD | Pass |
| Retic % | % | > 4.000 - 15.000 | 10* | 10.07 | 1.44% CV | Pass |
| IRF | N/A | ≥ 0.20 | 10 | 0.47 | 7.20% | Pass |
| MRV | fL | 100.0 - 120.0 | 10 | 118.40 | 1.19% CV | Pass |

*Control Material was used

## Repeatability Results for Body Fluids

| Parameter | Units | Level | N | Test Result<br>Mean | Test Result %CV<br>or SD | Acceptance |
|-----------|-----------|-----------------|----|---------------------|--------------------------|------------|
| BF-RBC | cells/mm³ | 10,000 - 15,000 | 10 | 12,643 | 2.42 | Pass |
| BF-TNC | cells/mm³ | 50-2,000 | 10 | 594 | 1.28 | Pass |

- c) Reproducibility testing was performed on the DxH 900-3S workcell using a single lot of all three (3) levels of 6C Plus, Retic-X, and Body Fluid cell controls. The table below shows the control material used for each material.

| Control Material Used | Parameter |
|--------------------------------------------|-----------|
| COULTER 6C PLUS Cell Control<br>(3 levels) | WBC |
| | RBC |
| | HGB |
| | MCV |
| | RDW |
| | RDW-SD |
| | PLT |
| | MPV |
| | NE |
| | LY |
| | MO |
| | EO |
| | BA |
| | NRBC |
| COULTER RETIC-X Cell Control<br>(3 levels) | RET |
| | |
| COULTER Body Fluids Control<br>(3 levels) | BF TNC |
| | BF RBC |

The controls were analyzed on one (1) DxH900-3S workcell, five (5) days, two (2) different times on the same day and three (3) shots per instrument, two (2) hours apart, per CLSI EP05-A3. The test instruments met the reproducibility specifications for all parameters.

{13}------------------------------------------------

| | | | N<br>Mean | Repeatability | | Between Runs | | Between Instrument | | Between Days | | Reproducibility | | |
|-------|-------------|---------------|-----------|------------------------|--------------|---------------|--------------|--------------------|--------------|--------------|--------------|-----------------|--------------|--------------|
| Level | Parameter | Unit | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| | WBC | 10^3 cells/uL | 90 | 3.42 | 0.07 | 1.90 | 0.00 | 0.00 | 0.04 | 1.26 | 0.01 | 0.27 | 0.08 | 2.30 |
| | RBC | 10^6 cells/uL | 90 | 1.74 | 0.01 | 0.59 | 0.00 | 0.11 | 0.00 | 0.26 | 0.00 | 0.00 | 0.01 | 0.66 |
| | HGB | g/dL | 90 | 4.62 | 0.02 | 0.43 | 0.00 | 0.00 | 0.01 | 0.26 | 0.01 | 0.13 | 0.02 | 0.52 |
| | MCV | Fl | 90 | 79.48 | 0.14 | 0.18 | 0.19 | 0.24 | 0.23 | 0.29 | 0.19 | 0.24 | 0.38 | 0.48 |
| | RDW | % | 90 | 17.09 | 0.15 | 0.89 | 0.14 | 0.82 | 0.08 | 0.44 | 0.00 | 0.03 | 0.22 | 1.28 |
| | RDW-SD | ਸ | 90 | 49.50 | 0.49 | 1.00 | 0.19 | 0.38 | 0.10 | 0.21 | 0.10 | 0.20 | 0.55 | 1.11 |
| | PLT | 10^3 cells/uL | 90 | 72.39 | 1.11 | 1.53 | 0.00 | 0.00 | 0.28 | 0.39 | 0.33 | 0.45 | 1.19 | 1.64 |
| | MPV | fL | 90 | 9.13 | 0.06 | 0.66 | 0.00 | 0.00 | 0.03 | 0.30 | 0.03 | 0.34 | 0.07 | 0.80 |
| Level | NE | % | 90 | 43.13 | 0.69 | 1.61 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.69 | 1.61 |
| l | LY | % | 90 | 46.24 | 0.72 | 1.56 | 0.00 | 0.00 | 0.12 | 0.25 | 0.00 | 0.00 | 0.73 | 1.58 |
| | MO | % | 90 | 6.67 | 0.40 | ર તેર | 0.00 | 0.00 | 0.15 | 2.29 | 0.00 | 0.00 | 0.43 | 6.38 |
| | EO | % | 90 | 3.94 | 0.34 | 8.58 | 0.14 | 3.67 | 0.00 | 0.00 | 0.00 | 0.00 | 0.37 | 9.33 |
| | BA | % | 90 | 0.02 | 0.02 | 74.92 | 0.00 | 0.00 | 0.00 | 0.00 | 0.01 | 26.29 | 0.02 | 79.39 |
| | NRBC | % | 90 | 0.29 | 0.10 | 34.20 | 0.00 | 0.00 | 0.05 | 15.62 | 0.00 | 0.00 | 0.11 | 37.60 |
| | RET | % | 90 | 0.87 | 0.10 | 11.18 | 0.02 | 2.71 | 0.15 | 17.41 | 0.00 | 0.00 | 0.18 | 20.86 |
| | BF TNC | cells/mm^3 | 90 | 120.74 | 6.51 | 5.39 | 3.63 | 3.01 | 3.41 | 2.83 | 3.18 | 2.64 | 8.79 | 7.28 |
| | BF RBC | cells/mm^3 | 90 | 12204.83 | 398.75 | 3.27 | 0.00 | 0.00 | 276.21 | 2.26 | 0.00 | 0.00 | 485.07 | 3.97 |
| | WBC | 10^3 cells/uL | 90 | 20.52 | 0.17 | 0.83 | 0.11 | 0.53 | 0.24 | 1.16 | 0.06 | 0.28 | 0.32 | ાં રેડ |
| | RBC | 10^6 cells/uL | 90 | 3.96 | 0.03 | 0.74 | 0.02 | 0.45 | 0.02 | 0.49 | 0.01 | 0.22 | 0.04 | 1.02 |
| | HGB | g/dL | 90 | 11.80 | 0.05 | 0.45 | 0.02 | 0.18 | 0.07 | 0.61 | 0.01 | 0.11 | 0.09 | 0.79 |
| | MCV | Fl | 90 | 87.38 | 0.19 | 0.22 | 0.05 | 0.05 | 0.25 | 0.29 | 0.15 | 0.17 | 0.35 | 0.40 |
| | RDW | % | 90 | 16.24 | 0.16 | 1.01 | 0.06 | 0.37 | 0.01 | 0.09 | 0.08 | 0.51 | 0.19 | 1.19 |
| | RDW-SD | fL | 90 | 52.73 | 0.67 | 1.27 | 0.14 | 0.26 | 0.08 | 0.14 | 0.17 | 0.32 | 0.71 | 1.35 |
| | PLT | 10^3 cells/uL | 90 | 424.58 | 7.98 | 1.88 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 7.98 | 1.88 |
| Level | MPV | fL | 90 | 9.44 | 0.06 | 0.58 | 0.00 | 0.00 | 0.05 | 0.54 | 0.02 | 0.18 | 0.08 | 0.82 |
| 2 | NE | % | 90 | 65.12 | 0.68 | 1.05 | 0.00 | 0.00 | 0.00 | 0.00 | 0.12 | 0.19 | 0.69 | 1.07 |
| | LY | % | 90 | 15.71 | 0.50 | 3.21 | 0.07 | 0.46 | 0.13 | 0.80 | 0.09 | 0.60 | 0.53 | 3.39 |
| | MO | % | 90 | 14.16 | 0.52 | 3.65 | 0.26 | 1.84 | 0.00 | 0.00 | 0.00 | 0.00 | 0.58 | 4.09 |
| | EO | % | 90 | 4.96 | 0.41 | 8.33 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.41 | 8.33 |
| | BA | % | 90 | 0.06 | 0.03 | 57.53 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.03 | 57.53 |
| | NRBC | % | 90 | 9.09 | 0.40 | 4.36 | 0.07 | 0.78 | 0.00 | 0.00 | 0.08 | 0.90 | 0.41 | 4.53 |
| | RET | 0% | 90 | 2.48 | 0.12 | 4.73 | 0.00 | 0.00 | 0.16 | 6.50 | 0.04 | 1.78 | 0.20 | 8.23 |
| | BF TNC | cells/mm^3 | 90 | 1526.92 | 20.38 | 1.33 | 4.95 | 0.32 | 11.01 | 0.72 | 12.20 | 0.80 | 26.64 | 1.74 |
| | BF RBC | cells/mm^3 | 90 | 1681333.92 | 8753.35 | 0.52 | 4306.83 | 0.26 | 16235.20 | 0.97 | 963.34 | 0.06 | 18965.22 | 1.13 |
| | WBC | 10^3 cells/uL | 90 | 8.58 | 0.10 | 1.20 | 0.00 | 0.00 | 0.04 | 0.47 | 0.03 | 0.40 | 0.12 | 1.35 |
| | RBC | 10^6 cells/uL | 90 | 5.28 | 0.03 | 0.62 | 0.02 | 0.33 | 0.04 | 0.77 | 0.01 | 0.24 | 0.06 | 1.07 |
| | HGB | g/dL | 90 | 15.61 | 0.09 | 0.59 | 0.00 | 0.00 | 0.14 | 0.89 | 0.04 | 0.29 | 0.17 | 1.10 |
| | MCV | F1 | 90 | 87.59 | 0.22 | 0.26 | 0.00 | 0.00 | 0.24 | 0.28 | 0.14 | 0.16 | 0.36 | 0.41 |
| | RDW | % | 90 | 15.47 | 0.17 | 1.09 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.17 | 1.09 |
| | RDW-SD | fL | 90 | 50.86 | 0.60 | 1.19 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.60 | 1.19 |
| | PLT | 10^3 cells/uL | 90 | 222.27 | 3.16 | 1.42 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 3.16 | 1.42 |
| Level | MPV | fL | 90 | 9.61 | 0.06 | 0.67 | 0.02 | 0.26 | 0.04 | 0.46 | 0.00 | 0.00 | 0.08 | 0.85 |
| 3 | NE | %<br>% | 90 | 57.05 | 0.81 | 1.42 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.81 | 1.42 |
| | LY | % | 90<br>90 | 27.73 | 0.59 | 2.13 | 0.00 | 0.00<br>0.00 | 0.00 | 0.00 | 0.00<br>0.00 | 0.00<br>0.00 | 0.59 | 2.13 |
| | MO | % | | 8.36 | 0.40 | 4.78 | 0.00 | | 0.00 | 0.00 | 0.00 | | 0.40 | 4.78 |
| | EO | % | 90<br>90 | 6.82 | 0.47<br>0.02 | 6.86<br>54.51 | 0.00<br>0.01 | 0.00<br>13.07 | 0.00<br>0.00 | 0.00<br>9.39 | 0.00 | 0.00<br>0.00 | 0.47<br>0.02 | 6.86 |
| | BA | % | 90 | 0.04 | | 2.66 | 0.00 | | | 2.52 | 0.09 | 0.45 | 0.72 | 56.83 |
| | NRBC<br>RET | % | 90 | 19.45<br>10.50 | 0.52<br>0.18 | 1.72 | 0.00 | 0.00<br>0.00 | 0.49<br>0.11 | | 0.07 | 0.69 | 0.23 | 3.69<br>2.14 |
| | BF TNC | cells/mm^3 | 90 | 65778.99 | 514.83 | 0.78 | 265.68 | 0.40 | 763.00 | 1.09<br>1.16 | 0.00 | 0.00 | 958.02 | 1.46 |
| | BF RBC | cells/mm^3 | | 90 5639354.09 50090.17 | | 0.89 | 0.00 | 0.00 | 32100.78 | 0.57 | 1922.28 | 0.03 | 59524.62 | 1.06 |

# Analysis for Instrument Combined

{14}------------------------------------------------

| Parameter | Unit | N | Mean | SD | CV% |
|-----------|------------|----|-------|------|------|
| BF RBC | cells/mm^3 | 11 | 73724 | 851 | 1.1 |
| | cells/mm^3 | 10 | 74706 | 1166 | 1.5 |
| | cells/mm^3 | 9 | 12624 | 407 | 3.2 |
| BF-TNC | cells/mm^3 | 10 | 309 | 9 | 3.1 |
| | cells/mm^3 | 11 | 1270 | 21 | 1.7 |
| | cells/mm^3 | 12 | 696 | 20 | 3.0 |
| | cells/mm^3 | 10 | 3070 | 65 | 2.1 |
| | cells/mm^3 | 10 | 24879 | 207 | 0.83 |
| | cells/mm^3 | 9 | 1281 | 26 | 2.0 |
| | cells/mm^3 | 10 | 214 | 10 | 4.9 |

#### Additional Body Fluid Precision Runs

- d) Linearity: Whole Blood and Body Fluid Linearity was tested on the DxH 900-3S workcell per CLSI EP06-A, 2nd Ed to assess system linearity of whole blood count parameters (WBC, RBC, PLT and HGB) and Body Fluids parameters (BF-RBC and BF-TNC) across the analytical measuring interval (AMI). Fresh whole blood was obtained and concentrated to achieve a high starting value near the upper limit of the AMI for each measurand. If values near the upper limit were not achieved using whole blood, surrogate (analog) cells were used instead. Dilutions were prepared of each measurand to cover the AMI and tested in quad…