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, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV

Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC

The DxH Slidemaker Stainer 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 Description

The DxH 800 and DxH SMS form a family of integrated and interactive modular products that are scalable to meet the specific laboratory workflow and workload needs. Currently these products are offered as stand-alone devices only.

DxH 800: 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 Five-part Differential (Diff), Reticulocyte (RET), Nucleated Red Blood Cell (NRBC) on whole blood, Total Nucleated Count (TNC) and Red Blood Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial)

DxH SMS: The DxH Slidemaker Stainer 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 upgrade of these devices with software v3.0 will allow for these stand-alone devices to be configured into five workcell configurations through physical and virtual connections. Physically, the instruments are connected via hardware and the virtual connection is accomplished by means of the new control system software that provides integrated process control, data consolidation and sample transport to the various instruments in the workcell in order to facilitate and improve laboratory efficiency. This will yield a total of seven product configurations, including:

Stand-alone DxH 800 with software v3.0
Stand-alone DxH SMS with software v3.0
Five customizable workcell configurations comprised of DxH 800 and DxH SMS with software v3.0
DxH 801 - one DxH 800 + one DxH SMS
DxH 1600 two DxH 800
DxH 1601 two DxH 800 + one DxH SMS
DxH 2400 three DxH 800
DxH 2401 three DxH 800 + one DxH SMS

These workcell configurations allow for increased system efficiencies through workload balancing between available instruments within the workcell, and automated pass through processing of selected slide preparation and stain test orders.

AI/ML Overview

This document describes the 510(k) premarket notification for the UniCel DxH 800 and DxH Slidemaker Stainer Coulter Cellular Analysis System, specifically referring to the update to software version 3.0.

Here's an analysis of the acceptance criteria and supporting studies, as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance characteristics and testing results rather than explicit "acceptance criteria" in a numerical or categorical format within a single table. It states that the device "meets the performance requirements." Based on the studies summarized, the implied acceptance criterion for each study is that the device demonstrates compliance with the respective performance requirement.

Study Type	Acceptance Criterion (Implied)	Reported Device Performance
Electromagnetic Compatibility (EMC) Interference	EMC interference of individual DxH 800 instruments is not impacted when configured in a workcell configuration.	"The analysis demonstrated that it is unlikely that EMC interference would be increased in the connected DxH workcell as compared to a stand-alone DxH 800."
Vibration Testing	Vibration introduced from interconnection of multiple DxH 800 and/or DxH SMS instruments in a workcell configuration does not impact the performance of the individual DxH 800 instruments.	"The analysis demonstrated that it is unlikely that vibration in the connected DxH workcell would impact performance."
Measurement Procedure Comparison: Whole Blood and Body Fluids	Bias between the test instruments (DxH 800 v3.0) versus the predicate DxH 800 v2.0 meets performance requirements, adhering to CLSI EP9-A3 and FDA Special Controls Guidance.	"Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the performance requirements for whole blood and body fluids bias when compared to the predicate device."
Imprecision (Repeatability): Whole Blood and Body Fluids	Repeatability of the DxH 800 meets performance specifications, adhering to CLSI H26-A2 and FDA Special Controls Guidance.	"Analysis of the data collected demonstrates that the DxH 800 v3.0 meets performance requirements for repeatability for whole blood and body fluids."
Limits (LoB, LLoD, LLOQ)	The DxH 800 meets the performance requirements for Limit of Blank (LoB), Lower Limit of Detection (LLoD), and Lower Limit of Quantitation (LLOQ), adhering to CLSI H26-A2 and EP17-A2.	"Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the performance requirements for LoB, LLoD, and LLoQ in whole blood and body fluids."
Linearity: Whole Blood and Body Fluids	Linearity of WBC, RBC, Hgb, Plt parameters for whole blood and TNC and BF-RBC parameters for body fluids meets performance requirements, adhering to CLSI H26-A2, EP06-A, and FDA Special Controls Guidance.	"Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the linearity performance requirements for whole blood and body fluids."
Carryover: Whole Blood and Body Fluid	Carryover for whole blood and body fluids on the DxH 800 meets performance specifications, adhering to CLSI H26-A2 and FDA Special Controls Guidance.	"Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the whole blood and body fluid carryover performance requirements."
Slide Quality (DxH SMS)	The DxH SMS produces slides that meet the slide quality specifications, adhering to CLSI H20-A2.	"The DxH SMS meets the performance requirements for slide quality."
Carryover (DxH SMS)	Carryover of the DxH SMS meets performance specifications for blood smear carryover.	"Analysis of the data collected demonstrates that the DxH SMS meets the performance requirements for blood smear carryover."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the various performance tests (e.g., for measurement procedure comparison, imprecision, linearity, carryover, slide quality).

The data provenance is not explicitly detailed regarding country of origin or whether it was retrospective or prospective. However, the studies are described as "Verification" or "Evaluation" and refer to "patient samples," implying that the testing was conducted with biological samples in a laboratory setting. The predicate device (v2.0) was manufactured by Beckman Coulter, suggesting the studies would likely be linked to their research and development activities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For the DxH SMS, the reference method is "Manually prepared blood films per the manual wedge-pull film technique as described in CLSI H20-A2," which implies human expert review, but the number and qualifications of these experts are not specified.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. For a device like an automated differential cell counter and slidemaker/stainer, ground truth is typically established against established manual methods and/or expert morphological review, but the specific adjudication process is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes an automated hematology analyzer and slidemaker/stainer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers' improvement with AI assistance is not applicable and was not performed or reported. The studies evaluate the device's technical performance against a predicate device or established manual methods.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are for the standalone performance of the UniCel DxH 800 and DxH SMS devices. The document focuses on the device's ability to accurately enumerate and identify blood parameters and prepare quality slides directly, without an explicit human-in-the-loop component being evaluated for its performance metrics. The performance characteristics compare the device's outputs to a predicate device (DxH 800 v2.0) or a manual reference method (for DxH SMS), assessing the algorithm's accuracy in a standalone capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth used varies by the study:

For the UniCel DxH 800 (measuring parameters like WBC, RBC, etc.): The ground truth for bias evaluation was established by comparison against a predicate device (UniCel DxH 800 Software 2.0), which itself would have been previously validated against established methods. The guidance documents (CLSI H26-A2, EP9-A3) also imply accepted reference measurement procedures.
For the UniCel DxH Slidemaker Stainer (DxH SMS): The ground truth for slide quality was established against the manual wedge-pull film technique as described in CLSI H20-A2. This CLSI standard is likely considered the gold standard for manual blood film preparation, implying that the "ground truth" for slide quality aligns with the criteria outlined in that standard, which would typically be assessed by trained laboratory professionals.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its sample size. This type of regulatory submission (510(k)) for an automated hematology analyzer typically focuses on verification and validation studies on a test set, demonstrating equivalence to an existing device or method. If machine learning was used in the development of the algorithms, information about the training set might be proprietary or not deemed necessary for this level of regulatory submission, especially if the changes are primarily integration and software.

9. How the Ground Truth for the Training Set was Established

As no information on a specific "training set" is provided, how its ground truth was established is not detailed in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 5, 2014

BECKMAN COULTER, INC. C/O MR. BRENT LEMBERG STAFF REGULATORY AFFAIRS SPECIALIST 11800 SW 147TH AVE. MIAMI FL 33196

Re: K140911

Trade/Device Name: UniCel DxH 800 and DxH Slidemaker Stainer Coulter Cellular Analysis System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 4, 2014 Received: August 6, 2014

Dear Mr. Lemberg:

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 (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 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.

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

UniCel® DxH 800 Coulter® Cellular Analysis System

Indications for Use (Describe)

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 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, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV

[ Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Maria MDChan -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments recarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31. 2017 See PRA Statement below.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration :

Indications for Use

510(k) Number (if known)

Device Name

UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Maria M. Chan -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Section 5	510(k) Summary
-----------	----------------

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510(k) Summary for UniCel® DxH 800 Coulter® Cellular Analysis System and UniCel DxH Slidemaker Stainer Coulter® Cellular Analysis System

510(k) Owner / Submitter Information

Name: Beckman Coulter Inc. Address: 11800 SW 147th Ave., Miami, FL 33196 Phone #: (305) 380-4509 Fax #: (305) 380-4344 Contact Person: Brent Lemberg Email Address: blemberg@beckman.com Date Submitted: April 10, 2014

Device Information

Trade Name: UniCel® DxH 800 Coulter® Cellular Analysis System Common Name: DxH 800 Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: GKZ Panel: Hematology

Trade Name: UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System Common Name: DxH SMS Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: GKZ Panel: Hematology

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Predicate Product	510(k)Number	DateCleared	Classification	21 CFR	ProductCode
UniCel® DxH 800 Coulter®Cellular Analysis System	K120771	March22, 2013	Class II	864.5220	GKZ
Manually prepared blood films perthe manual wedge-pull filmtechnique as described in CLSIH20-A2, Reference Leukocyte(WBC) Differential Count(Proportional) and Evaluation ofInstrument Methods: ApprovedStandard - Second Edition	N/A	N/A	N/A	N/A	N/A

Predicate Device Information

Device Description

. DxH 800: 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 Five-part Differential (Diff), Reticulocyte (RET), Nucleated Red Blood Cell (NRBC) on whole blood, Total Nucleated Count (TNC) and Red Blood Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial)
. DxH SMS: The DxH Slidemaker Stainer 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.

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Page 4 of 14

. Stand-alone DxH 800 with software v3.0
Stand-alone DxH SMS with software v3.0 ●
Five customizable workcell configurations comprised of DxH 800 and DxH SMS . with software v3.0
- o DxH 801 - one DxH 800 + one DxH SMS
- DxH 1600 two DxH 800 O
- DxH 1601 two DxH 800 + one DxH SMS O
- DxH 2400 three DxH 800 O
- o DxH 2401 three DxH 800 + one DxH SMS

Intended Use:

DxH 800 Indications for 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:

트 Whole Blood (Venous and Capillary)
- o 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
I Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV
트 Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC

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DxH SMS Indications for Use:

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Page 6 of 14

Technological Characteristics Comparisons to Predicate

DxH 800 Device Comparison Table:

Similarities
Characteristic	PredicateUniCel DxH 800 Software 2.0	DeviceUniCel DxH 800 Software 3.0
Indications foruse	The UniCel® DxH 800 Analyzer is a quantitative multi-parameter, automated hematologyanalyzer for in vitro diagnostic use in screening patient populations found in clinicallaboratories.The UniCel® DxH 800 Analyzer identifies and enumerates the parameters indicated belowon 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	Same as predicate
SamplingMechanism	Single aspiration probe used for all sampling. Single tube presentation – open and closed vial sampling – specimen manually mixed Automated cassette presentation – closed vial sampling from five- position cassetteaccepting a variety of defined specimen tubes. Cassette containing specimens mixedprior to starting sampling and between specimens. Maximum initial load capacity 20 cassettes - System will continuously process cassettesas added	Each DxH 800 in the workcell utilizes thesame sampling mechanism as thepredicate.

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Similarities
Characteristic	PredicateUniCel DxH 800 Software 2.0	DeviceUniCel DxH 800 Software 3.0
Mechanisms forProcessing	Mechanisms to achieve process of :o automated cassette transportation and specimen mixing (by rocking)o sample aspirationo sample preparationo sample and reagent presentation to analytical moduleso sample analysiso raw data collectiono algorithmic processingo data reportingSpecimen tube is in upright (cap up) position for closed vial samplingCassette transportation by magnetic drive allowing multi-directional moves and capability toreturn cassette to sampling position for repeat / reflex testing	Each DxH 800 in the workcell utilizes thesame mechanisms for processing as thepredicate except:In a connected configuration, specimentransportation capability between multipleDxH 800 analyzers. Repeat / reflextesting can be done on different analyzerthan initial testing.
Data Analysis	Raw information is digitized from all analytical modules and passed to workstation foralgorithmic processing.Algorithms using advanced mathematical methods for population differentiation and flaggingcentralized within workstation	Same as Predicate
Data Reporting	Workstation display graphics, hardcopy printing and transmission to host LaboratoryInformation System (LIS)	Same as Predicate

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Page 8 of 14

Similarities
Characteristic	PredicateUniCel DxH 800 Software 2.0	DeviceUniCel DxH 800 Software 3.0
PerformanceCharacteristics	The performance characteristics provided for:• Comparison of Measurement Procedures• Whole Blood – CBC• Whole Blood - Reticulocyte• Whole Blood - Differential• Whole Blood - NRBC• Body Fluids• Imprecision• Whole Blood CBC, DIFF, Retic• Prediluted Blood• CSF, Serous, Synovial Body Fluid• Linearity• Carryover (High to Low)• Whole Blood CBC, DIFF, Retic, NRBC, Body Fluids	Same as predicate with no changes tostated performance characteristics
OperatingPrinciples	Method of sample analysis	Same as predicate
Consumables	Reagents, controls, and calibrators utilized by the system	Same as predicate

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Page 9 of 14

Differences
Characteristic	PredicateUniCel DxH 800 Software 2.0	DeviceUniCel DxH 800 Software 3.0
SystemConfiguration	Workcell configuration of one DxH 800 (stand-alone) Bench top Optional Floor Stand - provides self-contained support for the analyzeras well as easy access storage for reagents and waste containers. PC based workstation running Microsoft Windows XP application specificsoftware	Individual analyzers are same as predicate exceptanalyzers can be connected creating multiple workcellconfigurations (up to three DxH 800s and up to 1 DxHSMS)Workcell configurations available only on a floor stand,not on a bench top.PC based workstation running Microsoft Windows 7application specific software
Workstation	Software functionality to control sample processing as well as patient andcontrol data management	Each DxH 800 in the workcell utilizes the samefunctionality as the predicate except one systemmanager controls sample processing and managementfor up to three DxH 800s plus one DxH SMS

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DxH SMS Device Comparison Table:

Characteristic	PredicateManual Method(H20-A2, Reference Leukocyte (WBC) Differential Count(Proportional) and Evaluation of Instrumental Methods;Approved Standard	DeviceUniCel DxH Slidemaker Stainer Software 3.0
Indications for use	Manual preparation of whole blood smears on microscopicslides using a variety of fixatives, stains, buffers, and rinsesolutions.	The DxH Slidemaker Stainer is a fully automated slidepreparation and staining device that aspirates a wholeblood sample, smears a blood film on a clean microscopeslide, and delivers a variety of fixatives, stains, buffers,and rinse solutions to that blood smear.
DeviceClassification &Product Code	Not applicable	21 CFR 864.5220 Automated Cell Counter, GKZ
Manufacturer	Not applicable	Beckman Coulter
SpecimenCollection	Whole venous blood in EDTA	Same as predicate
Blood FilmPreparation	Manually prepared by technician	Automatically prepared by DxH SMS
Blood FilmRequirements	Section 6.3.1 of CLSI H20-A2	Same as predicate

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Summary of DxH 800 Performance Testing

Study	Testing Approach	FDA Guidance Documents	Standards/ References	Testing Results
ElectromagneticCompatibility(EMC) Interference	Verify that the EMCinterference of individual DxH800 instruments is not impactedwhen configured in a workcellconfiguration.	None	None	The analysis demonstrated that it is unlikely thatEMC interference would be increased in theconnected DxH workcell as compared to astand-alone DxH 800.
Vibration Testing	Verify that vibration introducedfrom interconnection ofmultiple DxH 800 and/or DxHSMS instruments in a workcellconfiguration does not impactthe performance of theindividual DxH 800instruments.	None	None	The analysis demonstrated that it is unlikely thatvibration in the connected DxH workcell wouldimpact performance.
MeasurementProcedureComparison: WholeBlood and BodyFluids	To evaluate bias between thetest instruments versus thepredicate DxH 800 v2.0.	Special Controls GuidanceDocument: PremarketNotifications for AutomatedDifferential Cell Countersfor Immature or AbnormalBlood Cells - Accuracy(Section 8)	· Validation, Verification, andQuality Assurance of AutomatedHematology Analyzers, ApprovedStandard - 2nd Edition; June 2010;CLSI H26-A2; FDA StandardsRecognition # 7-210· Measurement ProcedureComparison and Bias EstimationUsing Patient Samples; ApprovedGuideline - Third Edition: CLSIEP9-A3; FDA StandardsRecognition # 7-245	Analysis of the data collected demonstrates thatthe DxH 800 v3.0 meets the performancerequirements for whole blood and body fluidsbias when compared to the predicate device.
Imprecision(Repeatability):Whole Blood andBody Fluids	To verify the imprecision(repeatability) of the DxH 800meets performancespecifications.	Special Controls GuidanceDocument: PremarketNotifications for AutomatedDifferential Cell Countersfor Immature or AbnormalBlood Cells - Precision(Section 9)	· Validation, Verification, andQuality Assurance of AutomatedHematology Analyzers, ApprovedStandard - 2nd Edition; June 2010;CLSI H26-A2; FDA StandardsRecognition # 7-210	Analysis of the data collected demonstrates thatthe DxH 800 v3.0 meets performancerequirements for repeatability for whole bloodand body fluids.
Study	Testing Approach	FDA Guidance Documents	Standards/ References	Testing Results
Limits (LoB, LLoD,LLOQ)	To verify that the DxH 800meets the performancerequirements for Limit of Blank(LoB), Lower Limit ofDetection (LLoD), Lower Limitof Quantitation (LLOQ).	None	• Validation, Verification, andQuality Assurance of AutomatedHematology Analyzers, ApprovedStandard - 2nd Edition; June 2010;CLSI H26-A2; FDA StandardsRecognition #7-210• Evaluation of Detection Capabilityfor Clinical Laboratory MeasurementProcedures; Approved Guideline -Second Edition; CLSI EP17-A2;FDA Standards Recognition #7-233	Analysis of the data collected demonstrates thatthe DxH 800 v3.0 meets the performancerequirements for LoB, LLoD, and LLoQ inwhole blood and body fluids.
Linearity: WholeBlood and BodyFluids	To verify linearity of WBC,RBC, Hgb and Plt parametersfor whole blood and TNC andBF-RBC parameters for bodyfluids.	Special Controls GuidanceDocument: PremarketNotifications for AutomatedDifferential Cell Countersfor Immature or AbnormalBlood Cells - Linearity(Section 11)	• Validation, Verification, andQuality Assurance of AutomatedHematology Analyzers, ApprovedStandard - 2nd Edition; June 2010;CLSI H26-A2; FDA StandardsRecognition #7-210• Evaluation of the Linearity ofQuantitative MeasurementProcedures: A Statistical Approach;Approved Guideline; April 2003.CLSI EP06-A; FDA StandardsRecognition #7-193	Analysis of the data collected demonstrates thatthe DxH 800 v3.0 meets the linearityperformance requirements for whole blood andbody fluids.
Carryover: WholeBlood and BodyFluid	To verify carryover for wholeblood and body fluids on theDxH 800 meets performancespecifications.	Special Controls GuidanceDocument: PremarketNotifications for AutomatedDifferential Cell Countersfor Immature or AbnormalBlood Cells - Carryover(Section 12)	• Validation, Verification, andQuality Assurance of AutomatedHematology Analyzers, ApprovedStandard - 2nd Edition; June 2010;CLSI H26-A2; FDA StandardsRecognition #7-210	Analysis of the data collected demonstrates thatthe DxH 800 v3.0 meets the whole blood andbody fluid carryover performance requirements.
Study	Testing Approach	FDA Guidance Documents	Standards/ References	Testing Results
Slide Quality	To verify that the DxH SMSproduces slides that meet theslide quality specifications.	None	CLSI H20-A2, Reference Leukocyte(WBC) Differential Count(Proportional) and Evaluation ofInstrumental Methods, ApprovedStandard - Second Edition; FDAStandards Recognition #7-165	The DxH SMS meets the performancerequirements for slide quality.
Carryover	To verify that the Carryover ofthe DxH SMS meets theperformance specifications.	None	None	Analysis of the data collected demonstrates thatthe DxH SMS meets the performancerequirements for blood smear carryover.

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Summary of DxH SMS Performance Testing:

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Substantial Equivalence Conclusion to Demonstrate Safety, Effectiveness & Equivalent Performance to Predicate:

The updates to the DxH 800 and DxH SMS with software v3.0 that are the subject of this submission, do not change the intended use, nor add or delete a contraindication for the device. The changes do not alter the device control mechanism, operating principle, energy type, environmental specification, ergonomics of the user interface, dimensional specifications, nor packaging. The device does not have expiration dating nor is it subject to sterilization.

The conclusions drawn from the performance testing discussed above demonstrate that the device is as safe, as effective, and meets the performance acceptance criteria.

In summary, the updated DxH 800 and DxH SMS with software v3.0, as described in this submission are substantially equivalent in terms of safety and effectiveness to their predicate device and reference method, respectively.

The UniCel DxH 800 Coulter Cellular Analysis System v3.0 is substantially equivalent to ● the UniCel DxH 800 Coulter Cellular Analysis System v2.0 manufactured by Beckman Coulter.
The UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System v3.0 is substantially equivalent to manually prepared blood films per the manual wedge-pull film technique as described in CLSI H20-A2, Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard

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

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

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