Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard hematology analyzer and its performance characteristics. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on traditional analytical methods and comparisons to a predicate device.

Therapeutic

No
This device is an in vitro diagnostic (IVD) hematology analyzer used for screening and identifying parameters in blood and body fluids. It is not designed to provide therapy or directly treat a condition.

Diagnostic

Yes

The device is intended for "in vitro diagnostic use in screening patient populations" and to "separate patients with normal hematological parameters from patients who need additional studies," which aligns with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system is comprised of the analyzer, an optional floor stand, and a suite of analytical reagents, quality control and calibration reagents, and reagents for system cleaning, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "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."
Explicit Statement in Device Description: The "Device Description" section also states: "The UniCel® DxH 800 COULTER® Cellular Analysis System (DxH 800) is intended for In Vitro Diagnostic Use in clinical laboratories."
Nature of the Device: The device analyzes biological samples (whole blood and body fluids) to provide quantitative measurements of various hematological parameters. This is the core function of an in vitro diagnostic device.
Clinical Laboratory Setting: The intended use specifies that the device is for use in clinical laboratories, which is a typical setting for IVD devices.
Purpose of the Results: The results are used to "separate patients with normal hematological parameters from patients who need additional studies," which directly contributes to the diagnosis and management of patient conditions.

All these points strongly indicate that the UniCel® DxH 800 COULTER® Analyzer is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

Product codes (comma separated list FDA assigned to the subject device)

GKZ

Device 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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. 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. 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.

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. 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. 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.

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. Analysis of the data collected demonstrates that the updated DxH 800 meets performance requirements for repeatability, (within acceptance limits) for all parameters reported.

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. Whole blood - WBC and PLT, Body Fluid - TNC and RBC. 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.

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. 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.

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. 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. Analysis of the data collected demonstrates that the updated DxH 800 meets the whole blood and body fluid carryover performance requirements (within acceptance limits), for the parameters measured.

Specimens Anticoagulant: Testing was performed on the updated DxH 800 to demonstrate equivalency of results for whole blood specimens collected into K₂ and K₃EDTA and analyzed using the CBC, Differential and Retic analytical cycle. Analysis of the data collected demonstrates that the updated DxH 800 meets performance requirements and provides comparable results, for all parameters reported, from specimens collected into K₂ and K₃EDTA.

Specimens Collection method: Testing was performed on the updated DxH 800 to demonstrate equivalency of results (within defined limits), for specimens collected by venipuncture and capillary collection methods and analyzed using the CBC, Differential and Retic analytical cycle. 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 collected by venipuncture and capillary collection methods and analyzed using the CBC, Differential and Reticulocyte analytical cycle.

Specimens Stability: Testing was performed on the updated DxH 800 to demonstrate whole blood specimen stability. Testing was performed on whole blood specimens at various time intervals (long-term and short-term) and stored at refrigerated and room temperature. In addition testing was performed on pre-diluted specimens. Analysis of the data collected demonstrates that the updated DxH 800 meets the performance requirements and claims with respect to whole blood long term, short term and pre-dilute sample stability.

Reference Ranges: Confirmatory testing was performed on the updated DxH 800 to demonstrate comparability of whole blood reference ranges for an adult population to the ranges established for the predicate device. The reference ranges established for the predicate DxH 800 are applicable for the updated DxH 800. The updated DxH 800 labeling will provide the reference ranges as currently presented in the predicate labeling.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Clinical Sensitivity and Specificity was used to assess the WBC Differential Suspect message flagging capability of the system.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K081930

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.”

Summary

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

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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

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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).

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UniCel® DxH 800 COULTER® Cellular Analysis System Update
510(k) submission
Section 5: 510(k) Summary - Updated

Page 11 of 22

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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

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:

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

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UniCel® DxH 800 COULTER® Cellular Analysis System Update
510(k) submission
Section 5: 510(k) Summary - Updated

Page 13 of 22

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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

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Page 14 of 22

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| 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. |

:

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510(k) submission
Section 5: 510(k) Summary - Updated

Page 15 of 22

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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

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Page 16 of 22

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| 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

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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. | Class II Special
Controls Guidance
Section 12 -
Carryover | 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 Documents
Guidelines for the evaluation of blood
cell analyzers including those used for
differential leukocyte and reticulocyte
counting and cell marker applications.
International Council for
Standardization in Haematology:
prepared by the ICSH expert panel on
cytometry. Clin Lab Haematol,
16(2):157-174, 1994. | Analysis of the data collected
demonstrates that the updated DxH
800 meets the whole blood and
body fluid carryover performance
requirements (within acceptance
limits), for the parameters
measured. |

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UniCel® DxH 800 COULTER® Cellular Analysis System Update
510(k) submission
Section 5: 510(k) Summary - Updated

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18

| Study | Specimens
Anticoagulant | Testing Approach | FDA Guidance
Documents | Standards / References | 510(k) Testing Summary |
|-------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Testing was performed on the
updated DxH 800 to
demonstrate equivalency of
results for whole blood
specimens collected into K₂
and K₃EDTA and analyzed
using the CBC, Differential
and Retic analytical cycle. | Class II Special
Controls Guidance
Section 13 -
Specimens | 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)

Procedures for the Collection of
Diagnostic Blood Specimens by
Venipuncture; Approved Standard -
Sixth Edition; October 2007; CLSI H3-
A6
(FDA Standards Recognition # 7-201)

Procedures and Devices for the
Collection of Diagnostic Capillary
Blood Specimens; Approved Standard -
Sixth Edition; September 2008; CLSI
H04-A6
(FDA Standards Recognition # 7-203)

User Verification of Performance for
Precision and Trueness Approved
Guideline; Approved Guideline -
Second Edition; June 2005; CLSI
EP15-A2
(FDA Standards Recognition # 7-153)

Reference Documents
Recommendations of the International
Council for Standardization in
Haematology for
ethylenediaminetetraacetic acid
anticoagulation of blood for blood cell
counting and sizing. Am J Clin Path,
100(4)371-372, 1993. | Analysis of the data collected
demonstrates that the updated DxH
800 meets performance
requirements and provides
comparable results, for all
parameters reported, from
specimens collected into K₂ and
K₃EDTA. |

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510(k) submission
Section 5: 510(k) Summary - Updated

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19

| Study | Testing Approach | FDA Guidance
Documents | Standards / References | 510(k) Testing Summary |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specimens
Collection
method | Testing was performed
on the updated DxH
800 to demonstrate
equivalency of results
(within defined limits),
for specimens collected
by venipuncture and
capillary collection
methods and analyzed
using the CBC,
Differential and Retic
analytical cycle. | Class II Special Controls
Guidance
Section 13 - Specimens | 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)
Procedures for the Collection of
Diagnostic Blood Specimens by
Venipuncture; Approved Standard - Sixth
Edition; October 2007; CLSI H3-A6
(FDA Standards Recognition # 7-201)
Procedures and Devices for the Collection
of Diagnostic Capillary Blood
Specimens; Approved Standard - Sixth
Edition; September 2008; CLSI H04-A6
(FDA Standards Recognition # 7-203)
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 collected by
venipuncture and capillary
collection methods and analyzed
using the CBC, Differential and
Reticulocyte analytical cycle. |
| Specimens
Stability | Testing was performed
on the updated DxH
800 to demonstrate
whole blood specimen
stability. Testing was
performed on whole
blood specimens at
various time intervals
(long-term and short-
term) and stored at
refrigerated and room
temperature. In addition
testing was performed
on pre-diluted
specimens. | Class II Special Controls
Guidance
Section 13 - Specimens | Standards Documents
None | Analysis of the data collected
demonstrates that the updated DxH
800 meets the performance
requirements and claims with
respect to whole blood long term,
short term and pre-dilute sample
stability. |

UniCel® DxH 800 COULTER® Cellular Analysis System Update
510(k) submission
Section 5: 510(k) Summary - Updated

Page 20 of 22

20

| Study | Testing Approach | FDA Guidance
Documents | Standards / References | 510(k) Testing Summary |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference
Ranges | Confirmatory testing
was performed on the
updated DxH 800 to
demonstrate
comparability of whole
blood reference ranges
for an adult population
to the ranges
established for the
predicate device. | Class II Special Controls
Guidance
Section 14 - Reference
Values | Standards Documents
Defining, Establishing, and Verifying
Reference Intervals in the Clinical
Laboratory; Approved Guideline – Third
Edition. CLSI C28-A3 (FDA Standards Recognition # 7-202) | The reference ranges established
for the predicate DxH 800 are
applicable for the updated DxH
800. The updated DxH 800
labeling will provide the reference
ranges as currently presented in the
predicate labeling. |

UniCel® DxH 800 COULTER® Cellular Analysis System Update
510(k) submission
Section 5: 510(k) Summary - Updated

21

9.0 Conclusion:

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

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.

' +

22

Image /page/22/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written in a circular pattern around the eagle. The seal is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 22, 2013

Beckman Coulter, Inc. c/o Mr. Eric Grace Senior Staff, Product Management 11800 SW 147th Avenue Miami, Florida 33196-2500

Re: K120771

Trade/Device Name: UniCel® DxH 800 COULTER® Cellular Analysis System Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: March 11, 2013 Received: March 14, 2013

Dear Mr. Grace:

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

23

Page 2 - Mr. Eric Grace

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 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 regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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

24

Indication for Use

510(k) Number (if known): K120771

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

Indication 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:

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%, RET#, MRV, IRF
이 Pre-Diluted Whole Blood (Venous and Capillary)
- WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, o PLT, MPV
Body Fluids (cerebrospinal, serous and synovial) ■ o TNC and RBC

Prescription Use X (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 (OVD)

Leonthena R. Carrington -S

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_K120771

UniCel® DxH 800 COULTER® Cellular Analysis System Update 510(k) submission Section 4: Indication for Use - Updated