K( (2077,'

0 BECKMAN MR2221Abbreviated 510(k) Summary for the MR221

Beckman Coulter UniCel® DxH 800 COULTER@ Cellular Analysis System

1.0 Submitted By:

Eric GraceSenior Staff, Product ManagementBeckman Coulter, Inc.11800 SW 147 1hAvenue, MIC: 3 1-B306Miami, Florida 33 196-2500Telephone: (305) 380-2728FAX: (305) 380-3618

2.0 Date Submitted:

March 13 "h, 2012

3.0 Device Name and Classification

Proprietary Name:UniCelt Dxll 800 COULTER9 Cellular Analysis System

Classification Number: 21 CFR § 864.5220 - Automated differential cellcounter

Classification: Class 11

Product Code: GKZ

Panel: Hematology

4.0 Predicate Device:

Prdct r 510O(K) Date ClsiiainProductPeiaePoduct Number Cleared Clsiiain 21 CFR CodeUniCel® Dx 800

COULTER® 013 1/920 Class 11 6.22 KCellular Analysis K013 121/086450 Z

System ____________

The updated DxH 800 system uses the same reagents, controls and calibrators as thecleared device; there are no changes to these products as a result of the changesprompting this submission of the DxH 800.

UniCeIm DxH 800 COULTERe Cellular Analysis System Update Page 1 of 225 10(k) submissionSection 5: 5 10(k) Summary - Updated

5.0 Description:

The updated DxH 800 with software version 2.0, the subject of this submission, uses thesame principles of operation, reagents, controls and calibrators as the original cleareddevice.

The UniCel®& DxH 800 COULTER® Cellular Analysis System (DxH 800) is intendedfor In Vitro Diagnostic Use in clinical laboratories. The DxH 800 System providesautomated complete blood count, leukocyte differential, nucleated red blood cell (NRBC)enumeration and reticulocyte analysis as well as an automated method for enumeration ofthe Total Nucleated Cells (TNC) and Red Blood Cells (RBC) in body fluids.

The DxH 800 System is intended to separate patients with normal hemnatologicalparameters from patients who need additional studies of any of these parameters. Thesestudies might include further measurements of cell size and platelet distribution, manualWBC differential or any other definitive test that helps diagnose the patient's condition.

The Dxli 800 system is comprised of the analyzer (see Figure I and Table 1), an optionalfloor stand (see Figure 2 and Table 2), and a suite of analytical reagents, quality controland calibration reagents, and reagents for system cleaning (see Table 3).

Figure 1: Bench top DxH 800 System

9*4

UniCel® Dxli 800 COULTER* Cellular Analysis System Update Page 2 of 225 10(k) submissionSectionS5: 5 1 0(k) Summary - Updated

Figure 1 # System Components Description / FunctionItem I Specimen Processing Module Process specimens - provides

(SPM) functionality for specimen transport,specimen identification and specimenmixing. Mixed specimens are sampledand required volumes of specimen aremixed and incubated with applicablereagents. The prepared specimen/reagentmix is presented to applicable analyticalmodules where the analysis and raw datageneration occurs. Raw data is sent toSystem Manager for analysis.

Item 2 System Manager Personal Computer (PC) basedworkstation running system applicationspecific software - Provides systemcontrol functions for the SPM. Receivesraw data from 5PM and performsanalysis to generate applicable parameterresults. Provides data management andstorage, provides test order management,results review and reporting, qualitycontrol functionality, diagnostics andmaintenance procedures. User interactionis provided via touch screen, keyboardand mouse. Connects with laboratoryinformation systems (LIS).

Item 3 Hand held Barcode scanner Provides user the capability for manualsample identification and entry ofbarcoded reagent information for reagent

___________ ________________________ tracking

Item 4 Pneumatic Supply Module Supplies vacuum and pressure to the_________(PSM) SPM for system operationTable 1: Description of DxH 800 components

UniCel® DxH 800 COULTER® Cellular Analysis System Update Page 3 of 225 10(k) submissionSectionS5: 5 1 0(k) Summary - Updated

Figure 2: DxH 800 System and Floor stand

Figure 2 # System Components Description I FunctionFloor Stand (Optional) Provides self-contained support for the

SPM as well as easy access storage forreagents and waste containers.Additionally, the Floor Stand houses thePneumatic Supply module on an

___________integrated pull-out shelfItem I Reagent Drawer Provides storage and 5PM supply tubing

for connection of two I OL Diluent_______________________ containers

Item 2 Waste Drawer Provides storage and SPM supply tubingfor connection of two I OL wastecontainers

Item 3 Reagent Drawer Provides storage and SPM supply tubingfor connection of Cell Lyse, Duff Pack,Retic Pack and Cleaner reagents

Item 4 Pneumatic Supply Module Provides storage and pressure vacuum________________________________supply connections for SPM

Table 2: Dxli 800 Floor stand

UniCel® DxH 800 COULTER" Cellular Analysis System Update Page 4 of 225 10(k) submissionSection 5: 5 10(k) Summary - Updated

Analtical Reagents: Description / FunctionCOULTERe DxH A cyanide-free, isotonic buffered saline solution, used to dilute theDliluent specimen prior to analysis. Used for rinsing the Sample Processing

__________________Module (SPM) components between sample analyses.COULTER10 DxH Cell A cyanide-free lytic reagent that lyses red blood cells to allowLyse enumeration and sizing of white blood-cell cells.

Works in conjunction with COULTER DxH Diluent to generate astable hemoglobin measurement.Used to discriminate nucleated red blood cells from white blood

____________________ cells

The COULTER® DxH The Pack contains two reagents; a cell lytic reagent and a cellDuff Pack preservative reagent. The lytic reagent is a cyanide-free reagent

that dilutes the blood sample, and lyses red blood cells to allowWBC differentiation. The preservative reagent neutralizes the lyticreagent and preserves the white blood cells for measurement in theflow cell. Together, they provide the five-part differential utilizing

_________________the VCSn technology.

COULTER® DxH Retic The pack contains a reticulocyte stain reagent and a reticulocyte-Pack 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 A cyanide-free, aldehyde-free cleaning agent that degradesCleaner residual materials so that they may be flushed from the system

____________________with the diluent.

Controls Description / FunctionCOULTER® 6C Cell An integrated control that enables monitoring of systemControl performance for all directly measured and calculated CBC, Diff

and NRBC parameters.COULTER® Retic-X A control product for monitoring system performance of theCell Control - reticulocyte parameters.COULTER® LIN-X A control product for the verification of the reportable range, andLinearity Control calibration assessment of the WBC, RBC, HOB, and PLT

parameters.COULTER® Body A control product for monitoring system performance of the bodyFluid Control fluid cycle's RBC and TNC count parameters. Additionally,

COULTER Body Fluid Control can be used for verification of themeasuring range of the TNC and RBC parameters in the bodyfluid panel.

COULTER" A control product used to monitor the volume, conductivity andLATRONTM CP-X light scatter parameter measurements.ControlCalibrators Description / FunctionCOULTER® S-CAL® Calibrator for determining calibration factors to ensure accurateCalibrator measurements of directly measured CRC parameters. Assigned

___________________assay values are traceable to reference methods.Table 3: DxH 800 Analytical reagent, controls and calibrator

UniCel® DxH 800 COULTER® Cellular Analysis System Update Page 5 of 22~5 10(k) submissionSection 5: 5 10(k) Summary - Updated

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 HemoglobinHCT HemnatocritMCV Mean Corpuscular Volume

MCH Mean Corpuscular Hemoglobin

MCHC Mean Corpuscular Hemoglobin ConcentrationRDW Red Cell Distribution WidthRDW-SD Red Cell Distribution Width Standard Deviation (SD)PLT Platelet count

MPV Mean Platelet VolumeNE Neutrophil percent

LY Lymphocyte percentMO Monocyte percent

EO Fosinophil percentBA Basophil percentNE# Neutrophil absolute number

LY# Lymphocyte absolute numberMO# Monocyte absolute numberEO# Eosinophil absolute number

BA# Basophil absolute number

NRBC Nucleated Red Blood Cell percentNRBC# Nucleated Red Blood Cell absolute number

RET Reticulocyte percentRET# Reticulocyte absolute numberMRV Mean Reticulocyte Volume1RF 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 - LOTA or heparin

Specimen Processing Methods

UniCel®O DxH 800 COULTER® Cellular Analysis System Update Page 6 of 225 10(k) submissionSection 5: 5 10(k) Summary - Updated

The Dx- 800 provides the user with the ability to obtain a variety of combinations ofparameter results through the use of analytical test panels. In addition the specimenanalysis can occur via a number of sampling methods on the analyzer.

The test panels and the parameters reported, along with the sampling method that areavailable to the user are shown in Table 5.

Test Panel Reported Parameters Specimen Sampling Methodtype __________________

Complete * WBC, RBC, HOB, HCT, * Automated Cassette Closed VialBlood Count MCV, MCH, MCHC, ROW, Whole Blood * Manual Single Tube Closed Vial

(CBC) RDW-SD, PLI', MPV * Manual Single Tube Open VialCBC and * WBC, RBC, IIGB, HICT,

Differential MCV, MCH, MCHC, ROW, * Automated Cassette Closed Vialinc NRBC RDW-SD, PLT, MPV, W .hole Blood * Manual Single Tube Closed Vial

NE%, NE#, LY%, LY#, MO%, * Manual Single Tube Open Vial(CD) MO#, EO%, EO#, BA%, BA#,

NRBC% and NRBC#. _ ___

CBC, * WBC, RBC, [lOB, HCT,Differential MCV, MCH, MCHC, ROW,inc NRBC RDW-SD, PLT, MPV, * Automated Cassette Closed Vialand Relic * NE%, NE#, LY%/, LY#, MO%, Whole Blood * Manual Single Tube Closed Vial

(CDR) MO#, EO%, EO#, BA%, BA#, * Manual Single Tube Open VialNRBC%, NRBC#,

* RET%, RFT/I, MRV, IRECBC and * WBC, RBC, HOB, HICT, * Automated Cassette Closed Vial

Retic MCV, MCI-, MCHC, ROW, Whole Blood * Manual Single Tube Closed Vial(CR) ROW-SD, PLT, MPV, * Manual Single Tube Open Vial

* RET%, RET/I, MRV, IRE _____

Retic * RET% RET#, MRV, IRF * Automated Cassette Closed Vial(R) Whole Blood * Manual Single Tube Closed Vial

Manual Single Tube Open VialPre-dilute * WBC, RBC, HOB, HCT, I in 5 Pre-(PreDilx5) MCV, MCH, MCI-IC, RDW, diluted whole * Manual Single Tube Open Vial

RDW-SD, PLT, MPV bloodBody Fluid * TNC, RBC Body Fluid

(BE) (cerebrospinal, * Mna igeTb pnVaserous and Mna igeTb pnVa

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 thewhole blood and body fluid specimens.

-Each cell suspended in a conductive liquid (diluent) acts as an insulator. As each cellgoes through the aperture, it momentarily increases the resistance of the electrical pathbetween two submerged electrodes on either side of the aperture. This causes ameasurable electronic pulse. While the number of pulses indicates particle count, theamplitude of the electrical pulse is proportional to the cell volume. These pulses are sentto the Signal Conditioner for analog to digital conversion. Pulse counts and digitizedpulse measurements are sent to the System Manager for processing by the algorithmswhere the reported parameter values, flags and histograms are generated.

UniCel" Dxii 800 COULTER® Cellular Analysis System Update Page 7 of 225 10(k) submissionSection 5: 5 10(k) Summary - Updated

The lytic reagent used for the white cell count prepares the blood so the system can countleukocytes and measure the amount of hemoglobin. The lytic reagent rapidly andsimultaneously destroys the erytbrocytes and converts a substantial proportion of thehemoglobin to a stable pigment while it leaves leukocyte nuclei intact. The absorbance ofthe pigment is directly proportional to the hemoglobin concentration of the sample.

Hemoglobin is measured photometrically at 525 nm using the sample from the white cellanalysis. Clean diluent is introduced into the cuvette during each operating cycle and isused 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 forthe WBC differential, NRBC and Retic analysis. The prepared sample is delivered to theflow cell for sample detection. As the cells pass through the sensing zone, a diode laserilluminates the particles causing light scatter and light absorption. Simultaneously to thelight scalier measurements, cell volume and cell conductivity are also measured.

The data collected during each of the analytical processes is transferred to the SystemManager where the digital raw values are processed by the algorithm using mathematicalapproaches designed for finding optimal separation between clusters of data. Theidentified 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 patientpopulations found in clinical laboratories.

The UniCel® DxH 800 COULTER® Analyzer identifies and enumerates the parametersindicated below on the following sample types:

* Whole Blood (Venous and Capillary)o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD,

PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#I, EO%, EON,BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF

a Pre-Diluted Whole Blood (Venous and Capillary)o WBC, RBC, HOB, HCT, MCV, MCH, MCHC, RDW, RDW-SD,

PLT, MPV

a 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 Page 8 of 225 1 0(k) submissionSection 5: 5 10(k) Summary - Updated

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9.0 Conclusion:

The data in the Premarket Notification on safety and effectiveness supports a finding that theUniCelti Dxli 800 COULTER® Cellular Analysis System Update with software version 2.0 issubstantially equivalent to the predicate device.

This summary of safety and effectiveness is being submitted in accordance with the requirementsof the Safe Medical Device Act of 1990 and the implementing regulation 21 0FR 807.92.

UniCel®o Dxli 800 COULTER* Cellular Analysis System Update Page 22 of 2251 0(k) submissionSection 5: 5 10(k) Summary - Updated

DEPARTMENT 01F HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration10903 New Hampshire AvenueDocument Control Center - W066-6609Silver Spring, MD 20993-0002

March 22, 2013

Beckman Coulter, Inc.c/o Mr. Eric GraceSenior Staff, Product Management11800SW 147d AvenueMiami, Florida 33 196-2500

Re: k 120771Trade/Device Name: UniCel® Dxli 800 COULTERS Cellular Analysis SystemRegulation Number: 21 CFR § 864.5220Regulation Name: Automated differential cell counterRegulatory Class: Class 11Product Code: GKZDated: March 11, 2013Received: March 14, 2013

Dear Mr. Grace:

We have reviewed your Section 5 1 0(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (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.

The general controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Act

Page 2 - Mr. Eric Grace

or any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasego to httv2://www.fda.gov/AboutFDA/CentersOffices/CDRHJ/CDR-Offices/ucml 1 5809.htm forthe Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, pleasenote the regulation entitled, "Misbranding by reference to premarket notification" (2ICFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go tohttp://www.fda.2~ov/MedicalDevices/Safetv/ReportaProblenl~defaulthtm for the CDRH' s Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet addresshtto2://www.fda.gov/MedicaiDevices/ResourcesforYou/industr/default.htm.

Sincerely yours,

Maria M)"han -SMaria M. Chan, Ph.D.DirectorDivision of Immunology and Hematology DevicesOffice of In Vitro Diagnostics and Radiological

HealthCenter for Devices and Radiological Health

Enclosure

Indication for Use

510(k) Number (if known): K120771

Device Name: UniCelo Dxli 800 COULTER® Cellular Analysis System

Indication for Use:

The UniCel®) DxH 800 Analyzer is a quantitative multi-parameter, automatedhematology analyzer for in vitro diagnostic use in screening patient populations found inclinical laboratories.

The UniCel& DxH 800 Analyzer identifies and enumerates the parameters indicatedbelow on the following sample types:

* Whole Blood (Venous and Capillary)o WBC, RBC, HGB, UCT, MCV, MCII, MCHC, RDW, RDW-SD,

PLT, MPV, NE%, NE#, LY%, LY#, MO%, MOlt, EO%, EOD#,BA%, BA#l, NRBC%, NRBC#l, RET0/, RET#, MRV, IRF

* Pre-Diluted Whole Blood (Venous and Capillary)o WvBC, RBC, HGB, HCT, MCV, MCH, MCI-C, RDW, RDW-SD,

PLT, MPV

" Body Fluids (cerebrospinal, serous and synovial)o TNC and RBC

Prescription Use X And/Or Over the Counter Use __

(21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDR.H, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-OffOffice of In Vitro Diagnostic DeviceEvaluation and Safety

510(k) K120771

UniCel® Dxli 800 COULTER" Cellular Analysis System Update Page 1 of 151 0(k) submissionSection 4: Indication for Use - Updated