Who is the manufacturer of UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM?

Beckman Coulter, Inc. filed the 510(k) submission for UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K120771).

What is the FDA product code for UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM?

GKZ. It is classified under 21 CFR 864.5220 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM?

UniCel® DxH 800 COULTER® Cellular Analysis System (k081930).

Who can help prepare an FDA 510(k) submission like UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

K120771 · Beckman Coulter, Inc. · GKZ · Mar 22, 2013 · Hematology

Device Facts

Record ID	K120771
Device Name	UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Applicant	Beckman Coulter, Inc.
Product Code	GKZ · Hematology
Decision Date	Mar 22, 2013
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 864.5220
Device Class	Class 2

Intended Use

The UniCel® DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and 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%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) - WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC

Device Story

Automated hematology analyzer; processes whole blood, pre-diluted blood, or body fluids. Uses impedance, radio frequency (RF), flow cytometric light scatter, and spectrophotometry to analyze cells. Input samples aspirated via probe; cells pass through aperture/sensing zone; electronic pulses and light scatter signals generated. System Manager processes digitized signals via algorithms to identify cell clusters, calculate counts, and generate histograms/flags. Output: CBC, differential, reticulocyte, and body fluid parameters displayed on workstation. Used in clinical laboratories by trained personnel. Output assists clinicians in hematological screening and diagnosis. Benefits: rapid, automated, standardized quantitative blood analysis.

Clinical Evidence

Bench testing only. Studies included accuracy/comparability (whole blood and body fluids), reproducibility (long-term imprecision), repeatability (short-term imprecision), linearity, carryover, and specimen stability. Performance demonstrated equivalence to the predicate device and manual reference methods. Clinical sensitivity and specificity for WBC differential flagging were equivalent or improved compared to the predicate.

Technological Characteristics

Benchtop or floor-stand automated hematology analyzer. Measurement principles: aperture impedance (Coulter Principle), spectrophotometry (HGB), and VCSn technology (DC impedance, RF conductivity, laser light scatter/absorbance). Connectivity: LIS integration via workstation. Software: PC-based workstation (Windows XP) with embedded analyzer application. Reagents: cyanide-free diluent, lyse, diff pack, retic pack, and cleaner.

Indications for Use

Indicated for in vitro diagnostic screening of patient populations in clinical laboratories using whole blood, pre-diluted whole blood, or body fluids (cerebrospinal, serous, synovial) to provide quantitative hematological parameters.

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 (k081930)

Related Devices

K061574 — COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 · Beckman Coulter, Inc. · Jul 21, 2006
K052905 — MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER · Beckman Coulter, Inc. · Nov 18, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ K 120771 Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black circle with two white curved lines inside. The company name is written in bold, black letters, with "BECKMAN" on top and "COULTER" below. # MAR 2 2 2013 # Abbreviated 510(k) Summary for the Beckman Coulter UniCel® DxH 800 COULTER® Cellular Analysis System ### 1.0 Submitted By: Eric Grace Senior Staff, Product Management Beckman Coulter, Inc. 11800 SW 147" Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-2728 FAX: (305) 380-3618 ### 2.0 Date Submitted: March 13th, 2012 ### 3.0 Device Name and Classification Proprietary Name: UniCel® DxH 800 COULTER® Cellular Analysis System Classification Number: 21 CFR § 864.5220 - Automated differential cell counter Classification: Class II Product Code: GKZ Panel: Hematology ### 4.0 Predicate Device: | Predicate Product | 510(K) Number | Date Cleared | Classification | 21 CFR | Product Code | |------------------------------------------------------------|------------------|-----------------|----------------|----------|-----------------| | UniCel® DxH 800 COULTER® Cellular Analysis System | K081930 | 12/19/2008 | Class II | 864.5220 | GKZ | The updated DxH 800 system uses the same reagents, controls and calibrators as the cleared device; there are no changes to these products as a result of the changes prompting this submission of the DxH 800. {1}------------------------------------------------ ### 5.0 Description: The updated DxH 800 with software version 2.0, the subject of this submission, uses the same principles of operation, reagents, controls and calibrators as the original cleared device. The UniCel® DxH 800 COULTER® Cellular Analysis System (DxH 800) is intended for In Vitro Diagnostic Use in clinical laboratories. The DxH 800 System provides automated complete blood count, leukocyte differential, nucleated red blood cell (NRBC) enumeration and reticulocyte analysis as well as an automated method for enumeration of the Total Nucleated Cells (TNC) and Red Blood Cells (RBC) in body fluids. The DxH 800 System is intended to separate patients with normal hematological parameters from patients who need additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patient's condition. The DxH 800 system is comprised of the analyzer (see Figure 1 and Table 1), an optional floor stand (see Figure 2 and Table 2), and a suite of analytical reagents, quality control and calibration reagents, and reagents for system cleaning (see Table 3). Figure 1: Bench top DxH 800 System Image /page/1/Picture/6 description: The image shows a laboratory setup with several pieces of equipment labeled with numbers. Component 1 is a large, white, automated analyzer. Component 2 is a computer monitor, keyboard, and mouse, while component 3 is a computer tower. Component 4 is a smaller, box-shaped device with a display screen and a handle. {2}------------------------------------------------ | Figure 1 # | System Components | Description / Function | |------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item 1 | Specimen Processing Module (SPM) | Process specimens - provides functionality for specimen transport, specimen identification and specimen mixing. Mixed specimens are sampled and required volumes of specimen are mixed and incubated with applicable reagents. The prepared specimen/reagent mix is presented to applicable analytical modules where the analysis and raw data generation occurs. Raw data is sent to System Manager for analysis. | | Item 2 | System Manager | Personal Computer (PC) based workstation running system application specific software - Provides system control functions for the SPM. Receives raw data from SPM and performs analysis to generate applicable parameter results. Provides data management and storage, provides test order management, results review and reporting, quality control functionality, diagnostics and maintenance procedures. User interaction is provided via touch screen, keyboard and mouse. Connects with laboratory information systems (LIS). | | Item 3 | Hand held Barcode scanner | Provides user the capability for manual sample identification and entry of barcoded reagent information for reagent tracking | | Item 4 | Pneumatic Supply Module (PSM) | Supplies vacuum and pressure to the SPM for system operation | Table 1: Description of DxH 800 components {3}------------------------------------------------ Image /page/3/Figure/0 description: This image is a title for a figure. The title reads "Figure 2: DxH 800 System and Floor stand". The title is written in a clear, sans-serif font. The text is left-aligned. Image /page/3/Picture/1 description: The image shows a laboratory setup with various pieces of equipment. On the left, there is a large machine with a rounded top, possibly an analyzer or testing device, accompanied by a computer monitor and keyboard on a mobile stand. To the right, there is a cabinet with open doors, revealing shelves containing boxes and containers, along with a coffee machine on a pull-out tray. The image also contains numbers 1-4 pointing to different parts of the cabinet. | Figure 2 # | System Components | Description / Function | | |------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | | Floor Stand (Optional) | Provides self-contained support for the SPM as well as easy access storage for reagents and waste containers. Additionally, the Floor Stand houses the Pneumatic Supply module on an integrated pull-out shelf. | | | | Item 1 | Reagent Drawer | Provides storage and SPM supply tubing for connection of two 10L Diluent containers | | | Item 2 | Waste Drawer | Provides storage and SPM supply tubing for connection of two 10L waste containers | | | Item 3 | Reagent Drawer | Provides storage and SPM supply tubing for connection of Cell Lyse, Diff Pack, Retic Pack and Cleaner reagents | | | Item 4 | Pneumatic Supply Module | Provides storage and pressure vacuum supply connections for SPM | Table 2: DxH 800 Floor stand {4}------------------------------------------------ | Analytical Reagents: | Description / Function | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | COULTER® DxH Diluent | A cyanide-free, isotonic buffered saline solution, used to dilute the specimen prior to analysis. Used for rinsing the Sample Processing Module (SPM) components between sample analyses. | | COULTER® DxH Cell Lyse | A cyanide-free lytic reagent that lyses red blood cells to allow enumeration and sizing of white blood cell cells. Works in conjunction with COULTER DxH Diluent to generate a stable hemoglobin measurement. Used to discriminate nucleated red blood cells from white blood cells | | The COULTER® DxH Diff Pack | The Pack contains two reagents; a cell lytic reagent and a cell preservative reagent. The lytic reagent is a cyanide-free reagent that dilutes the blood sample, and lyses red blood cells to allow WBC differentiation. The preservative reagent neutralizes the lytic reagent and preserves the white blood cells for measurement in the flow cell. Together, they provide the five-part differential utilizing the VCSn technology. | | COULTER® DxH Retic Pack | The pack contains a reticulocyte stain reagent and a reticulocyte- clearing reagent. The reticulocyte stain reagent is a cyanide-free reagent that uses a dye to stain reticulocytes. The reticulocyte- clearing reagent is a cyanide-free reagent that stabilizes the dye- reticulum complex to enhance discrimination of reticulocytes from mature red blood cells utilizing the VCSn technology. | | COULTER® DxH Cleaner | A cyanide-free, aldehyde-free cleaning agent that degrades residual materials so that they may be flushed from the system with the diluent. | | Controls | Description / Function | | COULTER® 6C Cell Control | An integrated control that enables monitoring of system performance for all directly measured and calculated CBC, Diff and NRBC parameters. | | COULTER® Retic-X Cell Control | A control product for monitoring system performance of the reticulocyte parameters. | | COULTER® LIN-X Linearity Control | A control product for the verification of the reportable range, and calibration assessment of the WBC, RBC, HGB, and PLT parameters. | | COULTER® Body Fluid Control | A control product for monitoring system performance of the body fluid cycle's RBC and TNC count parameters. Additionally, COULTER Body Fluid Control can be used for verification of the measuring range of the TNC and RBC parameters in the body fluid panel. | | COULTER® LATRON™ CP-X Control | A control product used to monitor the volume, conductivity and light scatter parameter measurements. | | Calibrators | Description / Function | | COULTER® S-CAL® Calibrator | Calibrator for determining calibration factors to ensure accurate measurements of directly measured CBC parameters. Assigned assay values are traceable to reference methods. | Table 3: DxH 800 Analytical reagent, controls and calibrator {5}------------------------------------------------ # Parameters The system has the capability to determine the hematologic parameters shown in Table 4. | WBC | White Blood Cell count | |--------|--------------------------------------------------------| | RBC | Red Blood Cell count (for Whole Blood and Body Fluids) | | HGB | Hemoglobin | | HCT | Hematocrit | | MCV | Mean Corpuscular Volume | | MCH | Mean Corpuscular Hemoglobin | | MCHC | Mean Corpuscular Hemoglobin Concentration | | RDW | Red Cell Distribution Width | | RDW-SD | Red Cell Distribution Width Standard Deviation (SD) | | PLT | Platelet count | | MPV | Mean Platelet Volume | | NE | Neutrophil percent | | LY | Lymphocyte percent | | MO | Monocyte percent | | EO | Eosinophil percent | | BA | Basophil percent | | NE# | Neutrophil absolute number | | LY# | Lymphocyte absolute number | | MO# | Monocyte absolute number | | EO# | Eosinophil absolute number | | BA# | Basophil absolute number | | NRBC | Nucleated Red Blood Cell percent | | NRBC# | Nucleated Red Blood Cell absolute number | | RET | Reticulocyte percent | | RET# | Reticulocyte absolute number | | MRV | Mean Reticulocyte Volume | | IRF | Immature Reticulocyte Fraction | | TNC | Total Nucleated Cell (Body Fluids) | Table 4: DxH 800 parameters ### Recommended anticoagulants | Whole blood and pre-diluted anti-coagulated blood | K2 or K3 - EDTA | |---------------------------------------------------|----------------------------| | Serous fluids | K2 or K3 - EDTA | | Synovial fluids (pretreated with Hyaluronidase) | K2 or K3 - EDTA or heparin | # Specimen Processing Methods UniCel® DxH 800 COULTER® Cellular Analysis System Update 510(k) submission Section 5: 510(k) Summary - Updated {6}------------------------------------------------ The DxH 800 provides the user with the ability to obtain a variety of combinations of parameter results through the use of analytical test panels. In addition the specimen analysis can occur via a number of sampling methods on the analyzer. | Test Panel | Reported Parameters | Specimen type | Sampling Method | |--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------| | Complete Blood Count (CBC) | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV | Whole Blood | Automated Cassette Closed Vial Manual Single Tube Closed Vial Manual Single Tube Open Vial | | CBC and Differential inc NRBC (CD) | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC% and NRBC#. | Whole Blood | Automated Cassette Closed Vial Manual Single Tube Closed Vial Manual Single Tube Open Vial | | CBC, Differential inc NRBC and Retic (CDR) | 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 | Whole Blood | Automated Cassette Closed Vial Manual Single Tube Closed Vial Manual Single Tube Open Vial | | CBC and Retic (CR) | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, RET%, RET#, MRV, IRF | Whole Blood | Automated Cassette Closed Vial Manual Single Tube Closed Vial Manual Single Tube Open Vial | | Retic (R) | RET% RET#, MRV, IRF | Whole Blood | Automated Cassette Closed Vial Manual Single Tube Closed Vial Manual Single Tube Open Vial | | Pre-dilute (PreDilx5) | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV | 1 in 5 Pre- diluted whole blood | Manual Single Tube Open Vial | | Body Fluid (BF) | TNC, RBC | Body Fluid (cerebrospinal, serous and synovial) | Manual Single Tube Open Vial | The test panels and the parameters reported, along with the sampling method that are available to the user are shown in Table 5. Table 5: DxH 800 test panels, reported parameters and sampling methods ### Test Principle The Coulter Principle of automated cell counting and sizing is used in the analysis of the whole blood and body fluid specimens. Each cell suspended in a conductive liguid (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. While the number of pulses indicates particle count, the amplitude of the electrical pulse is proportional to the cell volume. These pulses are sent to the Signal Conditioner for analog to digital conversion. Pulse counts and digitized pulse measurements are sent to the System Manager for processing by the algorithms where the reported parameter values, flags and histograms are generated. {7}------------------------------------------------ The lytic reagent used for the white cell count 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 white cell 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® VCSn technology is used to determine the white cell differential, nucleated red blood cell count and reticulocyte parameters along with associated flags, messages, histograms and dataplots. The sample preparation and analysis uses specific reagents and analytical processes for the WBC differential, NRBC and Retic analysis. The prepared sample is delivered to the flow cell for sample detection. As the cells pass through the sensing zone, a diode laser illuminates the particles causing light scatter and light absorption. Simultaneously to the light scatter measurements, cell volume and cell conductivity are also measured. The data collected during each of the analytical processes is transferred to the System Manager where the digital raw values are processed by the algorithm using mathematical approaches designed for finding optimal separation between clusters of data. The identified clusters are used to calculate the frequency of cells within each population, generate parameter values, flags, histograms and data plots. ### 6.0 Intended Use: The UniCel® DxH 800 COULTER® Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 COULTER® Analyzer identifies and enumerates the parameters indicated below on the following sample types: - Whole Blood (Venous and Capillary) - 0 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%, RET#, MRV, IRF - 트 Pre-Diluted Whole Blood (Venous and Capillary) - 0 WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV . - 요 Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC ### Indication for Use. See Intended Use above. UniCel® DxH 800 COULTER® Cellular Analysis System Update 510(k) submission Section 5: 510(k) Summary - Updated {8}------------------------------------------------ # omparison to Predicate: The tables below compare the predicate DxH 800 and the updated DxH 800 7.0 | Characteristic | UniCel® DxH800 Predicate | UniCel® DxH800 Update Test Device (Software 2.0) | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use and Function | The UniCel® DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 Analyzer provides a: Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF) | The Indications for Use for the updated DxH 800 have not changed. The statement has been reworded to provide clarity and specific information on the parameters reported from each of the specimen types that are analyzed on the device. The UniCel® DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and 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 and Capillary) WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) TNC and RBC | Page 9 of 22 {9}------------------------------------------------ | Principles of Measurement | | | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | WBC, RBC, MCV, Plt, BF-TNC, BF-RBC | Aperture impedance (Coulter® Principle) | Same as predicate DxH 800 | | Hgb | Spectrophotometric | Same as predicate DxH 800 | | WBC Differential, | VCSn Technology using : ■ Aperture impedance (DC) ■ Conductivity (RF) ■ Laser Light Scatter (Multiple angles) ■ Laser Light Absorbance | Same as predicate DxH 800 | | Retic | VCSn Technology using : ■ Aperture impedance (DC) ■ Conductivity (RF) ■ Laser Light Scatter (Multiple angles) ■ Laser Light Absorbance | Same as predicate DxH 800 | | NRBC | VCSn Technology using : ■ Aperture impedance (DC) ■ Conductivity (RF) ■ Laser Light Scatter (Multiple angles) ■ Laser Light Absorbance | Same as predicate DxH 800 | | Reagents | | | | Analysis Reagents | COULTER® DxH Diluent COULTER® DxH Diff Pack COULTER® DxH Retic Pack COULTER® DxH Cell Lyse | Same as predicate DxH 800 | | Quality Controls & Calibrator | COULTER® 6C Cell Control COULTER® Latron™ CP-X Control COULTER® RETIC-X Cell Control COULTER® LIN-X Control COULTER® Body Fluids Control COULTER® S-CAL® Calibrator kit | Same as predicate DxH 800 | | Cleaning Agent | COULTER® DxH Cleaner | Same as predicate DxH 800 | : UniCel® DxH 800 COULTER® Cellular Analysis System Update 510(k) submission Section 5: 510(k) Summary - Updated Page 10 of 22 ge of 10 {10}------------------------------------------------ | Pre-Analytic Features | | | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | System configuration | Bench top or Optional Floor Stand - provides self-contained support for the analyzer as well as easy access storage for reagents and waste containers. | Same as predicate DxH 800 | | Sampling Mechanism | PC based workstation running Microsoft Windows XP application specific software Handheld Barcode Scanner Printer Single tube presentation - open and closed vial sampling Automated presentation - closed vial sampling from 5 position cassette. | Same as predicate DxH 800 with: Updates to provide dedicated cassette and mixing profile for specific tubes. | | Mechanisms for processing | Maximum initial load capacity 20 racks. Mechanisms to achieve process of: automated cassette transportation and specimen mixing (by rocking), sample aspiration, sample preparation, sample and reagent presentation to analytical modules, sample analysis, raw data collection, algorithmic processing and data reporting Cassette transportation by magnetic drive allowing multi-directional moves and capability to return cassette to sampling position for repeat / reflex testing. | Same as predicate DxH 800 with: Updates for device reliability, manufacturability and serviceability. | | Sample identification | Sample aspiration module (SAM) mounted barcode reader for automated barcode reading of cassette and sample tube identifiers Manual barcode scanning of sample tube identifier (Handheld scanner) Manual keyboard entry of sample identifier | Same as predicate DxH 800 with: Corrections to address sample identification related recalls.Updates to add capability for host query communication with Laboratory Information System (LIS). | . * UniCel® DxH 800 COULTER® Cellular Analysis System Update 510(k) submission Section 5: 510(k) Summary - Updated Page 11 of 22 . {11}------------------------------------------------ | Sample Processing | | | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Aspiration Pathway | Single sampling probe and common aspiration pathway used for all sample presentation modes. | Same as predicate DxH 800 | | Sample aspiration volume | Automatic, cap-piercing: 165 µL Single tube - open-vial and cap pierce: 165 µL Predilute 165 µL - fixed ratio of 1 in 5 dilution of blood with diluent | Same as predicate DxH 800 | | Sample Preparation | Rotary blood sampling valve (BSV) and syringe aspiration / dispense for blood segmentation / distribution Rotary ceramic piston pumps driven by stepper motors for reagent delivery CBC dilutions mixed vial tangential delivery to baths VCSn dilutions mixed by air jet in reaction chambers Reagents are temperature stabilized for analysis reactions | Same as predicate DxH 800 | | Throughput : Automated cassette processing | CBC ≥100 specimens per hour CBC/Diff≥100 specimens per hour CBC/Diff/NRBC ≥ 90 specimens per hour Any cycle with Retic ≥45 specimens per hour | Same as predicate DxH 800 | | Data Analysis | Throughput is based on normal specimens – analytical cycle times are increased with cytopenic specimens. Raw information is digitized from all analytical modules and passed to workstation for algorithmic processing. Algorithms using advanced mathematical methods for population differentiation and flagging centralized within workstation | Same as Predicate DxH 800 with: Enhancements for improved flagging | | Data reporting | Workstation display graphics, hardcopy printing and transmission to Laboratory Information System (LIS) | Same as Predicate DxH 800 with: Corrections to address data reporting related recalls. Updates to include revised LIS communication protocol to improve software performance and additional printer support functions. | UniCel® DxH 800 COULTER® Cellular Analysis System Update 510(k) submission Section 5: 510(k) Summary - Updated Page 12 of 22 · : {12}------------------------------------------------ | System Control | | | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Controlling software | System software (embedded and workstation) designed specific to support all features of DxH 800 | Same as DxH 800 predicate with: | | | The software system consists of a Data Manager component, a System Manager component (including algorithms), the User Interface, all of which are resident in the Workstation. In addition an Embedded Application is resident in the analyzer. The Embedded application uploads from the workstation on system power-up. | Corrections to address software related recalls. | | | | Updates to improve removal of cleaning agent during Shutdown and Daily Checks and monitoring of Sample and Sheath pressure sensors reading to detect when sensors are disconnected | | | | | | | | Software architecture changes that provide a foundation for future product enhancements and platform expansion. | | | Extensive real time monitoring and reporting of system status including: 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 | | | Performance | | | | Performance Claims | As stated in the Instructions for Use for the predicate device. | Performance claims are the same as the predicate DxH 800 with the following updates based on alignment to current clinical testing standards | | | | Updated Operating and Measuring ranges for selected parameters | | | | To align selected parameter lower limits with background, Limit of Blank, Limit of Detection and Limit of Quantitation. To align selected upper parameter limits with values seen in clinical conditions. Updated NRBC Carryover specification | . № ' UniCel® DxH 800 COULTER® Cellular Analysis System Update 510(k) submission Section 5: 510(k) Summary - Updated Page 13 of 22 . • {13}------------------------------------------------ # Summary of Performance Data 8.0 | Study | Testing Approach | FDA Guidance Documents | Standards / References | 510(k) Testing Summary | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Accuracy - Comparability Whole blood and Body fluid | Whole blood and Body Fluid accuracy (comparability) testing was performed to demonstrate the updated DxH 800 meets accuracy claims (Bias and/or Difference) limits over the measuring ranges defined in product labeling. | Class II Special Controls Guidance Section 8 - Accuracy | Standards Documents Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, Approved Standard – 2nd Edition; June 2010; CLSI H26-A2 (FDA Standards Recognition # 7-210) Method Comparison and Bias Estimation Using Patient Samples; CLSI EP9-A2 (FDA Standards Recognition # 7-92) Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; CLSI H20-A2 (FDA Standards Recognition # 7-165) Body Fluid Analysis for Cellular Composition; CLSI H56-A (FDA Standards Recognition # 7-163) | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements and provides results within acceptance limits for parameters reported from whole blood, when compared to the predicate device and for differential parameters when compared to manual reference results. In addition the updated DxH 800 meets the performance requirements and provides results within acceptance limits for parameters reported from body fluid, when compared to the manual chamber count. | | Accuracy - Comparability Analytical cycles | Testing was performed on the updated DxH 800 to demonstrate equivalency of results (within defined limits) between the whole blood analytical cycles (test panels), CBC (C), CBC/DIFF (CD), CBC/DIFF/Retic (CDR), CBC/Retic (CR), Retic (R) when specimens are analyzed using the automated closed vial sample processing method. In addition testing was performed to demonstrate equivalency between specimens analyzed as whole blood and as Pre-dilute (PD) specimens | Class II Special Controls Guidance Section 8 - Accuracy | Standards Documents Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, Approved Standard – 2nd Edition; June 2010; CLSI H26-A2 (FDA Standards Recognition # 7-210) User Verification of Performance for Precision and Trueness Approved Guideline; Approved Guideline - Second Edition; June 2005; CLSI EP15-A2 (FDA Standards Recognition # 7-153) | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements and provides comparable results for all parameters reported from specimens analyzed as whole blood in the available analytical cycles and when analyzed as whole blood and pre-dilute samples. | UniCel® DxH 800 COULTER® Cellular Analysis System Update 510(k) submission Section 5: 510(k) Summary - Updated : Page 14 of 22 · {14}------------------------------------------------ | Study | Testing Approach | FDA Guidance Documents | Standards / References | 510(k) Testing Summary | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Accuracy– Comparability Sampling modes | Testing was performed to demonstrate comparability between the sampling modes available on the updated DxH 800. Testing compared the automated closed vial with the manual closed vial sampling and the manual closed vial with the manual open vial methods using the CBC, Differential and Retic analytical cycle. | Class II Special Controls Guidance Section 8 - Accuracy | Standards Documents Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, Approved Standard - 2nd Edition; June 2010; CLSI H26-A2 (FDA Standards Recognition # 7-210) User Verification of Performance for Precision and Trueness Approved Guideline; Approved Guideline - Second Edition; June 2005; CLSI EP15-A2 (FDA Standards Recognition # 7-153) | Analysis of the data collected demonstrates that the updated DxH 800 meets performance requirements to provide comparable results for all parameters reported, for specimens analyzed using the sampling methods available (automated closed vial, manual closed vial and manual single tube open vial). | | Reproducibility | Testing was performed on the updated DxH 800 to demonstrate the long term imprecision of the device. Testing was performed using multiple levels of control materials for CBC, Differential, NRBC, Retic and Body Fluid parameters. | Class II Special Controls Guidance Section 9 - Precision | Standards Documents Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, Approved Standard - 2nd Edition; June 2010; CLSI H26-A2 (FDA Standards Recognition # 7-210) Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second edition; August 2004. CLSI EP05-A2 (FDA Standards Recognition # 7-110) | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements (within acceptance limits) for reproducibility (long term imprecision) using control products. | : UniCel® DxH 800 COULTER® Cellular Analysis System Update 510(k) submission Section 5: 510(k) Summary - Updated Page 15 of 22 ge of 15 {15}------------------------------------------------ | Study | Testing Approach | FDA Guidance Documents | Standards / References | 510(k) Testing Summary | |---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Repeatability | Testing was performed on the updated DxH 800 to demonstrate the short term imprecision of the device. Testing was performed using replicate measurements of specimens in the normal range, at medical decision levels and over the analytical measuring interval. Testing was performed on whole blood, pre-diluted whole blood and body fluid specimens | Class II Special Controls Guidance Section 9 - Precision | Standards Documents Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, Approved Standard - 2nd Edition; June 2010; CLSI H26-A2 (FDA Standards Recognition # 7-210) Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second edition; August 2004. CLSI EP05-A2 (FDA Standards Recognition # 7-110) Body Fluid Analysis for Cellular Composition; Approved Guideline, June 2006. CLSI H56-A (FDA Standards Recognition # 7-163) Reference Documents Hubl, W.; Tlustos, L.and M. Bayer, Use of precision profiles to evaluate precision of the automated leukocyte differential. Clinical Chemistry 42:7, 1068, 1996. | Analysis of the data collected demonstrates that the updated DxH 800 meets performance requirements for repeatability, (within acceptance limits) for all parameters reported. | UniCel® DxH 800 COULTER® Cellular Analysis System Update 510(k) submission Section 5: 510(k) Summary - Updated : Page 16 of 22 . · {16}------------------------------------------------ | Study | Testing Approach | FDA Guidance Documents | Standards / References | 510(k) Testing Summary | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance LoB, LLOD, LLOQ | Limit of Blank, Lower Limit of Detection and Lower Limit of Quantitation testing was performed for the parameters where there is a clinical interest (medical decision level) on very low or near zero values. | Class II Special Controls Guidance Section 10 - Performance | Standards Documents Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, Approved Standard – 2nd Edition; June 2010; CLSI H26-A2 (FDA Standards Recognition # 7-210) Protocols for Determination of Limits of Detection and Limits of Quantitation; CLSI EP17-A (FDA Standards Recognition # 7-194) | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements for LoB, LLoD and LLOQ results (within acceptance limits), for the WBC and PLT parameters in whole blood and the BF-TNC and BF-RBC parameters in body fluids. | | | Whole blood • WBC and PLT Body Fluid • TNC and RBC | | | | | Performance Clinical Sensitivity and Specificity | Clinical Sensitivity and Specificity are used to assess the ability of a test to detect presence or absence of a condition/abnormality. For the updated DxH 800, Clinical Sensitivity and Specificity was used to assess the WBC Differential Suspect message flagging capability of the system. | Class II Special Controls Guidance Section 10 - Performance | Standards Documents Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, Approved Standard – 2nd Edition; June 2010; CLSI H26-A2 (FDA Standards Recognition # 7-210) Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; CLSI H20-A2 (FDA Standards Recognition # 7-165) Reference Documents The International Consensus Group for Hematology Review: Suggested Criteria for Action Following Automated CBC and WBC Differential Analysis; Laboratory Hematology, 11:83-90, 2005 | Analysis of the data collected demonstrates that the updated DxH 800 provided equivalent or improved performance for Clinical Sensitivity and Specificity as compared to the predicate device analyzing the same data set. | · UniCel® DxH 800 COULTER® Cellular Analysis System Update 510(k) submission Section 5: 510(k) Summary - Updated . Page 17 of 22 . f 17 {17}------------------------------------------------ | Study | Testing Approach | FDA Guidance Documents | Standards / References | 510(k) Testing Summary | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Linearity Whole blood and Body fluid | Testing was performed on the updated DxH 800 to demonstrate the linearity of the device. Linearity was assessed by demonstrating that the reported results are directly proportional to the concentration of the measurand in a test sample for whole blood and body fluids. | Class II Special Controls Guidance Section 11 - Linearity | Standards Documents Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, Approved Standard - 2nd Edition; June 2010; CLSI H26-A2 (FDA Standards Recognition # 7-210) Evaluation of the Linearity of Quantitative Measurement; Approved Guideline; April 2003. CLSI EP06-A (FDA Standards Recognition #7-193) | Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements and provides linear results, within acceptance limits, for Whole blood and Body Fluid. | | Carryover Whole blood and Body fluid | Testing was performed to demonstrate whole blood and body fluid carryover performance of the updated DxH 800 by determining the impact of a specimen having high parameter values preceding a specimen with low parameter values. This testing also serves substantiate the modified NRBC carryover claim for the updated DxH 800. |…

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

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UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

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