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
a Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)

Device Description

The UniCel® DxH 800 Coulter® Cellular Analysis System (DxH 800 System) is intended for In Vitro Diagnostic Use in clinical laboratories. The DxH 800 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis as well as an automated method for enumeration of RBCs and TNCs in body fluids.
The purpose of the DxH 800 System is intended to separate the normal patient. with all normal system-generated parameters, from the patient who needs 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 instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hematological parameters through the use of impedance, RF, flow cytometric light scatter, spectrophotometry, and supravital staining methodologies. Additional reagents provide system cleaning and quality control and calibration.

AI/ML Overview

The provided text for the UniCel® DxH 800 Coulter® Cellular Analysis System (K081930) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with acceptance criteria.

Therefore, the information required to fully answer your request regarding acceptance criteria and the study proving the device meets them is not explicitly available in the provided document.

However, I can extract what is stated and highlight the missing information:

1. A table of acceptance criteria and the reported device performance

The document broadly states: "Accuracy, repeatability (precision), measuring (linearity) range and carryover studies were conducted and demonstrated acceptable performance per the manufacturer specifications."

Missing Information:

Specific numerical acceptance criteria for accuracy, repeatability, linearity, and carryover for each parameter (e.g., WBC, RBC, Hgb, etc.).
The actual reported performance values for each of these criteria.

Characteristic	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
Accuracy	To be determined by manufacturer	"demonstrated acceptable performance"
Repeatability	To be determined by manufacturer	"demonstrated acceptable performance"
Linearity	To be determined by manufacturer	"demonstrated acceptable performance"
Carryover	To be determined by manufacturer	"demonstrated acceptable performance"

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing Information:

Specific sample sizes used for accuracy, repeatability, linearity, and carryover studies.
Data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is an automated hematology analyzer, not an imaging device requiring expert interpretation for ground truth in the typical sense (like radiology). Ground truth for hematology analyzers is usually established by reference methods or validated manual counts.

Missing Information:

Details on how ground truth was established for the performance studies (e.g., specific reference methods, manual microscopy, or comparison to predicate). If manual microscopy was used for differential counts, the number and qualifications of technicians would be relevant, but this is not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing Information:

Adjudication methods are not applicable nor mentioned for this type of device and performance testing.

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

Missing Information:

MRMC studies are typically for medical imaging devices where human readers interpret cases. This is an automated laboratory analyzer, so an MRMC study is not relevant and was not conducted or mentioned.

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

This device is a standalone automated analyzer. Its performance data (accuracy, precision, linearity) inherently represent its standalone performance, as it is designed to replace or assist manual methods in laboratories. The summary refers to "acceptable performance per the manufacturer specifications," implying standalone performance.

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

Missing Information:

The document does not specify the type of ground truth (e.g., specific reference methods, manual counts, or comparison to predicate devices) used for the performance studies. For hematology parameters, ground truth is often established using established reference methods, manual microscopy, or comparisons to well-characterized predicate devices.

8. The sample size for the training set

The device is an automated hematology analyzer, not an AI/ML device that requires a "training set" in the common machine learning sense. Its algorithms are based on established physical principles (impedance, RF, flow cytometry, spectrophotometry) and pre-determined thresholds and calculations.

Missing Information:

Not applicable in the context of this traditional automated laboratory device.

9. How the ground truth for the training set was established

Missing Information:

Not applicable as it's not an AI/ML device with a "training set."

Summary

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KOH30

DEC 1 9 2008

510(k) Summary UniCel® DxH 800 Coulter® Cellular Analysis System

1.0 Submitted By:

Lourdes Coba Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4079 FAX: (305) 380-4344

2.0 Date Submitted:

July 3, 2008

3.0 Device Name(s):

3.1 Proprietary Names

UniCel® DxH 800 Coulter® Cellular Analysis System

3.2 Classification Name

Automated differential cell counter (21 CFR § 864.5220)

4.0 Predicate Devices:

Candidate	Predicates	Manufacturer	DocketNumber
UniCel® DxH 800Coulter® CellularAnalysis System	COULTER® LH 750Hematology Analyzer	Beckman Coulter, Inc.	K011342
	COULTER® LH 780Hematology Analyzer	Beckman Coulter, Inc.	K061616

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5.0 Description:

The purpose of the DxH 800 System is intended to separate the normal patient. with all normal system-generated parameters, from the patient who needs 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 instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hematological parameters through the use of impedance, RF, flow cytometric light scatter, spectrophotometry, and supravital staining methodologies. Additional reagents provide system cleaning and quality control and calibration.

6.0 Intended Use:

a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood
a Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)

UniCel® DxH 800 Analyzer Abbreviated 510(k) Notification

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Characteristic	COULTER® LH 750 (Predicate)	COULTER® LH 780 (Predicate)	UniCel® DxH 800
Intended Use	The COULTER LH 750Hematology Analyzer is aquantitative, automatedhematology analyzer andleukocyte differential counterFor In Vitro Diagnostic Use inclinical laboratories. TheCOULTER LH 750 HematologyAnalyzer provides automatedReticulocyte analysis andenumeration of nucleated redblood cells (NRBCs) as well asan automated method forenumeration of RBCs andWBCs in body fluids.	The COULTER LH 780 HematologyAnalyzer is a quantitative, automatedhematology analyzer and leukocytedifferential counter For In VitroDiagnostic Use in clinicallaboratories. The COULTER LH 780Hematology Analyzer providesautomated Reticulocyte analysis andenumeration of nucleated red bloodcells (NRBCs) as well as anautomated method for enumerationof RBCs and WBCs in body fluids.	The UniCel® DxH 800 Analyzer is aquantitative, automated hematologyanalyzer for in vitro diagnostic use inscreening patient populations found inclinical laboratories. The UniCel® DxH800 Analyzer provides:■ a Complete Blood Count (CBC),Leukocyte 5 Part Differential(Diff), Reticulocyte (Retic) andNucleated Red Blood Cell (NRBC)on whole blood■ a Total Nucleated Count (TNC) andRed Cell Count (RBC) on BodyFluids (cerebrospinal, serous andsynovial) (BF)
ParametersIVD	WBC, RBC, Hgb, Hct, MCV,MCH, MCHC, RDW, Plt, MPV,LY%, MO%, NE%, EO%,BA%, LY#, MO#, NE#, EO#,BA#, NRBC%, NRBC#, RET%,RET#, IRF, & MRV.	WBC, RBC, Hgb, Hct, MCV, MCH,MCHC, RDW, RDW-SD, Plt, MPV,LY%, MO%, NE%, EO%, BA%,LY#, MO#, NE#, EO#, BA#,NRBC%, NRBC#, RET%, RET#,IRF, & MRV.	Same as LH 750 / 780 except WBCreported as Total Nucleated Cell Count(TNC) in body fluids
Characteristic	COULTER® LH 750 (Predicate)	COULTER® LH 780 (Predicate)	UniCel® DxH 800
QualityControlTechniques	Daily Instruments Check,Commercial Controls, DeltaChecks, Patient Controls, XBAnalysis, & IQAP.	Daily Instruments Check,Commercial Controls, Delta Checks,Patient Controls, XB Analysis, &IQAP, Extended QC & XM Analysis	Same as LH 750 / 780
QualityControls &Calibrator	COULTER® 5C® Cell ControlCOULTER® Latron™ Primerand Latron ControlCOULTER® RETIC-C™ CellControlCOULTER® LIN-C® LinearityControlCOULTER® S-CAL®calibrator kit	COULTER® 5C® Cell ControlCOULTER® Latron™ Primer andLatron ControlCOULTER® RETIC-C™ CellControlCOULTER® LIN-C® LinearityControlCOULTER® S-CAL® CalibratorKit	COULTER® 6C Cell Control (pendingclearance K081822)COULTER® Latron™ CP-X Control(same product as Latron Control)COULTER® RETIC-X Cell Control(same product as Retic-C)COULTER® LIN-X control (pendingclearance K081641)COULTER® S-CAL® Calibrator kitCOULTER® Body Fluids Control(pending 510k submission)
	COULTER® LH Series DiluentCOULTER® Isoton 4 DiluentCOULTER LH Series PakCOULTER® LH Series RETICPak	COULTER® LH Series DiluentCOULTER® Isoton 4 DiluentCOULTER® LH Series PakCOULTER® LH Series RETIC Pak	COULTER® DH DiluentCOULTER® DH Diff PackCOULTER® DH Retic PackCOULTER® DH Cell Lyse
	AnalysisReagents	COULTER® Lyse S® III lyticagentCOULTER® Lyse S® 4 lyticagent	COULTER® Lyse S® III lytic agentCOULTER® Lyse S® 4 lytic agent

Comparison to Predicate(s) 7.0

UniCel® DxH 800 Analyzer
Abbreviated 510(k) Notification

Page 20

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UniCel® DxH 800 Analyzer
Abbreviated 510(k) Notification

Page 21

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UniCel® DxH 800	COULTER® DH Cleaner
COULTER® LH 780 (Predicate------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	COULTER® LH Series Cleaner
TH 750Predicate)COULTER®------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	CLENZCOULTER®
CharacteristicA STATE A STATE LEAST PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTY	CleaningAgent

UniCel® DxH 800 Analyzer
Abbreviated 510(k) Notification

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8.0 Summary of Performance Data:

Accuracy, repeatability (precision), measuring (linearity) range and carryover studies were conducted and demonstrated acceptable performance per the manufacturer specifications. The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.

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.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 9 2008

Beckman Coulter, Inc. C/o Lourdes Coba 11800 S.W. 147th Avenue Miami, Florida 33196

Re: K081930

Trade/Device Name: Unicel® DxH 800® Coulter Cellular Analysis System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: December 16, 2008 Received: December 17, 2008

Dear Ms. Coba:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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Page 2 -- Ms. Coba

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Josephine Bautista

ing Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

15081930 510(k) Number (if known):

Device Name: UniCel® DxH 800 Coulter® Cellular Analysis System

Indications For Use:

트 a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood
I a Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)

Prescription Use × (21 CFR Part 801 Subpart D) And/Or

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Josephine Bautista

Division Office/of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081930

Page 1 of 1

UniCel® DxH 800 Analyzer Abbreviated 510(k) Notification Page 16

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.”