(373 days)
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)
- 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
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, an optional floor stand, and a suite of analytical reagents, quality control and calibration reagents, and reagents for system cleaning.
Here's a breakdown of the acceptance criteria and study information for the Beckman Coulter UniCel® DxH 800 COULTER® Cellular Analysis System, based on the provided document:
Acceptance Criteria and Device Performance
The general acceptance criteria are that the updated DxH 800 system meets the performance requirements (within acceptance limits) for its claimed parameters, demonstrating comparability or equivalency to the predicate device and/or manual reference methods. Specific numerical acceptance limits are not provided in this summary, but the "510(k) Testing Summary" column indicates that the device met these unstated performance requirements.
Table of Acceptance Criteria (Generic) and Reported Device Performance
| Study Type | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Accuracy - Comparability (Whole Blood & Body Fluid) | Meets accuracy claims (Bias and/or Difference) limits over defined measuring ranges. | 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) | Equivalency of results (within defined limits) between different analytical cycles and between whole blood and pre-dilute 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) | Comparability between automated closed vial, manual closed vial, and manual open vial sampling methods. | 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 | Meets performance requirements (within acceptance limits) for long-term imprecision using control products. | 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 | Meets performance requirements (within acceptance limits) for short-term imprecision. | 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 | Meets performance requirements (within acceptance limits) for Limit of Blank, Lower Limit of Detection, and Lower Limit of Quantitation. | 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 | Equivalent or improved performance for WBC Differential Suspect message flagging capability compared to the predicate device. | 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 | Meets performance requirements and provides linear results (within acceptance limits) for whole blood and body fluid. | 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 | Meets whole blood and body fluid carryover performance requirements (within acceptance limits). | 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 | Meets performance requirements and provides comparable results for specimens collected into K₂ and K₃EDTA. | 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 | Meets performance requirements and provides comparable results for specimens collected by venipuncture and capillary methods. | 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 | Meets performance requirements and claims with respect to whole blood long term, short term, and pre-dilute sample stability. | 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 | 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. |
Study Details:
-
Sample Sizes Used for the Test Set and Data Provenance:
- The document does not explicitly state specific sample sizes for each test set. It mentions "analysis of the data collected" for each performance study.
- Data Provenance: The document does not explicitly state the country of origin. It refers to "patient samples" and "control materials." Given Beckman Coulter is based in Miami, Florida (USA), clinical studies are often conducted within the US or aligned with US regulatory standards. The CLSI (Clinical and Laboratory Standards Institute) standards cited are internationally recognized but a primary focus in the US. The studies are retrospective in the sense that the performance data for the updated DxH 800 is being compared to an existing predicate device (K081930), which would imply using comparable data sets or collecting new data for comparison. The document states, for clinical sensitivity and specificity, the comparison was made "analyzing the same data set" as the predicate, suggesting some retrospective analysis of existing data. However, the performance studies themselves likely involved prospective collection of samples for the updated device's testing.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document explicitly mentions comparison to "manual reference results" for differential parameters and "manual chamber count" for body fluid parameters.
- However, it does not specify the number of experts used or their qualifications (e.g., "radiologist with 10 years of experience").
- The CLSI H20-A2 standard ("Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods") is cited, which typically outlines procedures for establishing manual differential counts, often involving trained morphologists or medical technologists.
-
Adjudication Method for the Test Set:
- The document does not explicitly describe adjudication methods for the test set. For manual reference methods, standard practice often involves review by a trained expert, possibly with a second review in cases of discrepancy, but this is not detailed in the summary.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This device is an automated hematology analyzer, not an AI-assisted diagnostic imaging device that typically involves human readers. The comparative studies focus on the device's performance against a predicate device or manual reference methods, not human reader performance.
-
Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Yes, the studies described are primarily standalone performance evaluations of the UniCel® DxH 800 system itself. This device is the algorithm, providing automated results for various hematologic parameters. The "human-in-the-loop" aspect exists in clinical practice (e.g., reviewing flagging results, performing manual differentials when indicated), but the performance studies focus on the automated system's accuracy, precision, and other analytical specifications. The "Clinical Sensitivity and Specificity" study for WBC differential flagging assesses the algorithm's ability to correctly identify cases needing further review, which can be seen as a measure of its standalone utility in a screening context.
-
Type of Ground Truth Used:
- Expert Consensus/Manual Reference Methods: For differential parameters, "manual reference results" were used. For body fluid parameters, "manual chamber count" was the ground truth.
- Predicate Device Data: For many parameters, the updated DxH 800 was compared against the "predicate device" (UniCel® DxH 800, K081930). This implies the predicate device's established performance served as a form of "ground truth" or a benchmark for equivalency.
-
Sample Size for the Training Set:
- The document is a 510(k) summary for an update to an existing device (software version 2.0 of the DxH 800). The underlying principles (Coulter Principle, VCSn technology) and reagents are the same as the predicate device. Therefore, a separate "training set" in the modern machine learning sense is not explicitly mentioned or likely relevant for this software update submission. The "algorithms using advanced mathematical methods for population differentiation and flagging" would have been developed and "trained" during the original device's development (K081930), and this submission focuses on demonstrating that the updated software maintains or improves performance.
-
How the Ground Truth for the Training Set Was Established:
- As noted above, a distinct "training set" for the software update is not detailed. For the original device's algorithms, the ground truth would have been established through extensive studies comparing automated counts and differentiation with expert-reviewed manual microscopy (e.g., manual differential counts performed by experienced morphologists) and possibly other reference methods over a large and diverse set of patient samples. This process would involve adhering to standards like CLSI H20-A2, which describes the reference leukocyte differential count method.
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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 | DateCleared | Classification | 21 CFR | ProductCode |
|---|---|---|---|---|---|
| UniCel® DxH 800COULTER®Cellular AnalysisSystem | 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.
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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.
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| 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
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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 theSPM as well as easy access storage forreagents and waste containers.Additionally, the Floor Stand houses thePneumatic Supply module on anintegrated pull-out shelf. | ||
| Item 1 | Reagent Drawer | Provides storage and SPM supply tubingfor connection of two 10L Diluentcontainers | |
| Item 2 | Waste Drawer | Provides storage and SPM supply tubingfor connection of two 10L wastecontainers | |
| Item 3 | Reagent Drawer | Provides storage and SPM supply tubingfor connection of Cell Lyse, Diff Pack,Retic Pack and Cleaner reagents | |
| Item 4 | Pneumatic Supply Module | Provides storage and pressure vacuumsupply connections for SPM |
Table 2: DxH 800 Floor stand
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| Analytical Reagents: | Description / Function |
|---|---|
| COULTER® DxHDiluent | A cyanide-free, isotonic buffered saline solution, used to dilute thespecimen prior to analysis. Used for rinsing the Sample ProcessingModule (SPM) components between sample analyses. |
| COULTER® DxH CellLyse | A cyanide-free lytic reagent that lyses red blood cells to allowenumeration and sizing of white blood cell cells.Works in conjunction with COULTER DxH Diluent to generate astable hemoglobin measurement.Used to discriminate nucleated red blood cells from white bloodcells |
| The COULTER® DxHDiff Pack | The Pack contains two reagents; a cell lytic reagent and a cellpreservative reagent. The lytic reagent is a cyanide-free reagentthat dilutes the blood sample, and lyses red blood cells to allowWBC differentiation. The preservative reagent neutralizes the lyticreagent and preserves the white blood cells for measurement in theflow cell. Together, they provide the five-part differential utilizingthe VCSn technology. |
| COULTER® DxH ReticPack | The pack contains a reticulocyte stain reagent and a reticulocyte-clearing reagent. The reticulocyte stain reagent is a cyanide-freereagent 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 frommature red blood cells utilizing the VCSn technology. |
| COULTER® DxHCleaner | A cyanide-free, aldehyde-free cleaning agent that degradesresidual materials so that they may be flushed from the systemwith the diluent. |
| Controls | Description / Function |
| COULTER® 6C CellControl | An integrated control that enables monitoring of systemperformance for all directly measured and calculated CBC, Diffand NRBC parameters. |
| COULTER® Retic-XCell Control | A control product for monitoring system performance of thereticulocyte parameters. |
| COULTER® LIN-XLinearity Control | A control product for the verification of the reportable range, andcalibration assessment of the WBC, RBC, HGB, and PLTparameters. |
| COULTER® BodyFluid Control | A control product for monitoring system performance of the bodyfluid cycle's RBC and TNC count parameters. Additionally,COULTER Body Fluid Control can be used for verification of themeasuring range of the TNC and RBC parameters in the bodyfluid panel. |
| COULTER®LATRON™ CP-XControl | A control product used to monitor the volume, conductivity andlight scatter parameter measurements. |
| Calibrators | Description / Function |
| COULTER® S-CAL®Calibrator | Calibrator for determining calibration factors to ensure accuratemeasurements of directly measured CBC parameters. Assignedassay values are traceable to reference methods. |
Table 3: DxH 800 Analytical reagent, controls and calibrator
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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
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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 |
|---|---|---|---|
| CompleteBlood 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 andDifferentialinc 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,Differentialinc NRBCand 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 andRetic(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 wholeblood | Manual Single Tube Open Vial |
| Body Fluid(BF) | TNC, RBC | Body Fluid(cerebrospinal,serous andsynovial) | 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.
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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
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omparison to Predicate: The tables below compare the predicate DxH 800 and the updated DxH 800 7.0
| Characteristic | UniCel® DxH800Predicate | UniCel® DxH800 UpdateTest 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 |
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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 DiluentCOULTER® DxH Diff PackCOULTER® DxH Retic PackCOULTER® DxH Cell Lyse | Same as predicate DxH 800 |
| Quality Controls &Calibrator | COULTER® 6C Cell ControlCOULTER® Latron™ CP-X ControlCOULTER® RETIC-X Cell ControlCOULTER® LIN-X ControlCOULTER® Body Fluids ControlCOULTER® 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
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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 XPapplication specific softwareHandheld Barcode ScannerPrinterSingle tube presentation - open and closed vial samplingAutomated 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 reportingCassette 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 identifiersManual barcode scanning of sample tube identifier (Handheld scanner)Manual keyboard entry of sample identifier | Same as predicate DxH 800 with:Corrections to address sample identification related recalls.Updates to add capability for host query communication with Laboratory Information System (LIS). |
. *
UniCel® DxH 800 COULTER® Cellular Analysis System Update
510(k) submission
Section 5: 510(k) Summary - Updated
Page 11 of 22
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| Sample Processing | ||
|---|---|---|
| Aspiration Pathway | Single sampling probe and common aspiration pathway usedfor all sample presentation modes. | Same as predicate DxH 800 |
| Sample aspirationvolume | Automatic, cap-piercing: 165 µLSingle tube - open-vial and cap pierce: 165 µLPredilute 165 µL - fixed ratio of 1 in 5 dilution of blood withdiluent | Same as predicate DxH 800 |
| Sample Preparation | Rotary blood sampling valve (BSV) and syringe aspiration /dispense for blood segmentation / distributionRotary ceramic piston pumps driven by stepper motors forreagent deliveryCBC dilutions mixed vial tangential delivery to bathsVCSn dilutions mixed by air jet in reaction chambersReagents are temperature stabilized for analysis reactions | Same as predicate DxH 800 |
| Throughput :Automated cassetteprocessing | CBC ≥100 specimens per hourCBC/Diff≥100 specimens per hourCBC/Diff/NRBC ≥ 90 specimens per hourAny cycle with Retic ≥45 specimens per hour | Same as predicate DxH 800 |
| Data Analysis | Throughput is based on normal specimens – analytical cycletimes are increased with cytopenic specimens.Raw information is digitized from all analytical modules andpassed to workstation for algorithmic processing.Algorithms using advanced mathematical methods forpopulation differentiation and flagging centralized withinworkstation | Same as Predicate DxH 800 with:Enhancements for improved flagging |
| Data reporting | Workstation display graphics, hardcopy printing andtransmission to Laboratory Information System (LIS) | Same as Predicate DxH 800 with:Corrections to address data reporting related recalls.Updates to include revised LIS communicationprotocol to improve software performance andadditional printer support functions. |
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Section 5: 510(k) Summary - Updated
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| 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 CurrentsSystem Pressure and VacuumSystem TemperaturesMotor activityMechanism Sensor statusReagent Pump OperationRaw 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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Summary of Performance Data 8.0
| Study | Testing Approach | FDA GuidanceDocuments | Standards / References | 510(k) Testing Summary |
|---|---|---|---|---|
| Accuracy -ComparabilityWhole blood andBody fluid | Whole blood and Body Fluidaccuracy (comparability)testing was performed todemonstrate the updated DxH800 meets accuracy claims(Bias and/or Difference) limitsover the measuring rangesdefined in product labeling. | Class II SpecialControls GuidanceSection 8 - Accuracy | Standards DocumentsValidation, Verification, and QualityAssurance of Automated HematologyAnalyzers, Approved Standard – 2ndEdition; June 2010; CLSI H26-A2(FDA Standards Recognition # 7-210)Method Comparison and BiasEstimation Using Patient Samples;CLSI EP9-A2 (FDA StandardsRecognition # 7-92)Reference Leukocyte (WBC)Differential Count (Proportional) andEvaluation of Instrumental Methods;CLSI H20-A2 (FDA StandardsRecognition # 7-165)Body Fluid Analysis for CellularComposition; CLSI H56-A(FDA Standards Recognition # 7-163) | Analysis of the data collecteddemonstrates that the updated DxH800 meets the performancerequirements and provides resultswithin acceptance limits forparameters reported from wholeblood, when compared to thepredicate device and fordifferential parameters whencompared to manual referenceresults. In addition the updatedDxH 800 meets the performancerequirements and provides resultswithin acceptance limits forparameters reported from bodyfluid, when compared to themanual chamber count. |
| Accuracy -ComparabilityAnalytical cycles | Testing was performed on theupdated DxH 800 todemonstrate equivalency ofresults (within defined limits)between the whole bloodanalytical cycles (test panels),CBC (C), CBC/DIFF (CD),CBC/DIFF/Retic (CDR),CBC/Retic (CR), Retic (R)when specimens are analyzedusing the automated closedvial sample processingmethod. In addition testingwas performed to demonstrateequivalency betweenspecimens analyzed as wholeblood and as Pre-dilute (PD)specimens | Class II SpecialControls GuidanceSection 8 - Accuracy | Standards DocumentsValidation, Verification, and QualityAssurance of Automated HematologyAnalyzers, Approved Standard – 2ndEdition; June 2010; CLSI H26-A2(FDA Standards Recognition # 7-210)User Verification of Performance forPrecision and Trueness ApprovedGuideline; Approved Guideline -Second Edition; June 2005; CLSIEP15-A2(FDA Standards Recognition # 7-153) | Analysis of the data collecteddemonstrates that the updated DxH800 meets the performancerequirements and providescomparable results for allparameters reported fromspecimens analyzed as whole bloodin the available analytical cyclesand when analyzed as whole bloodand pre-dilute samples. |
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| Study | Testing Approach | FDA GuidanceDocuments | Standards / References | 510(k) Testing Summary |
|---|---|---|---|---|
| Accuracy–ComparabilitySampling modes | Testing was performed todemonstrate comparabilitybetween the sampling modesavailable on the updated DxH800. Testing compared theautomated closed vial with themanual closed vial samplingand the manual closed vialwith the manual open vialmethods using the CBC,Differential and Reticanalytical cycle. | Class II SpecialControls GuidanceSection 8 - Accuracy | Standards DocumentsValidation, Verification, and QualityAssurance of Automated HematologyAnalyzers, Approved Standard - 2ndEdition; June 2010; CLSI H26-A2(FDA Standards Recognition # 7-210)User Verification of Performance forPrecision and Trueness ApprovedGuideline; Approved Guideline -Second Edition; June 2005; CLSIEP15-A2(FDA Standards Recognition # 7-153) | Analysis of the data collecteddemonstrates that the updated DxH800 meets performancerequirements to providecomparable results for allparameters reported, for specimensanalyzed using the samplingmethods available (automatedclosed vial, manual closed vial andmanual single tube open vial). |
| Reproducibility | Testing was performed on theupdated DxH 800 todemonstrate the long termimprecision of the device.Testing was performed usingmultiple levels of controlmaterials for CBC,Differential, NRBC, Retic andBody Fluid parameters. | Class II SpecialControls GuidanceSection 9 - Precision | Standards DocumentsValidation, Verification, and QualityAssurance of Automated HematologyAnalyzers, Approved Standard - 2ndEdition; June 2010; CLSI H26-A2(FDA Standards Recognition # 7-210)Evaluation of Precision Performance ofQuantitative Measurement Methods;Approved Guideline - Second edition;August 2004. CLSI EP05-A2(FDA Standards Recognition # 7-110) | Analysis of the data collecteddemonstrates that the updated DxH800 meets the performancerequirements (within acceptancelimits) for reproducibility (longterm imprecision) using controlproducts. |
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| Study | Testing Approach | FDA GuidanceDocuments | Standards / References | 510(k) Testing Summary |
|---|---|---|---|---|
| Repeatability | Testing was performed on theupdated DxH 800 todemonstrate the short termimprecision of the device.Testing was performed usingreplicate measurements ofspecimens in the normalrange, at medical decisionlevels and over the analyticalmeasuring interval. Testingwas performed on wholeblood, pre-diluted whole bloodand body fluid specimens | Class II SpecialControls GuidanceSection 9 - Precision | Standards DocumentsValidation, Verification, and QualityAssurance of Automated HematologyAnalyzers, Approved Standard - 2ndEdition; June 2010; CLSI H26-A2(FDA Standards Recognition # 7-210)Evaluation of Precision Performance ofQuantitative Measurement Methods;Approved Guideline – Second edition;August 2004. CLSI EP05-A2(FDA Standards Recognition # 7-110)Body Fluid Analysis for CellularComposition; Approved Guideline,June 2006. CLSI H56-A(FDA Standards Recognition # 7-163)Reference DocumentsHubl, W.; Tlustos, L.and M. Bayer,Use of precision profiles to evaluateprecision of the automated leukocytedifferential. Clinical Chemistry 42:7,1068, 1996. | Analysis of the data collecteddemonstrates that the updated DxH800 meets performancerequirements for repeatability,(within acceptance limits) for allparameters reported. |
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| Study | Testing Approach | FDA GuidanceDocuments | Standards / References | 510(k) Testing Summary |
|---|---|---|---|---|
| PerformanceLoB, LLOD,LLOQ | Limit of Blank, Lower Limitof Detection and Lower Limitof Quantitation testing wasperformed for the parameterswhere there is a clinicalinterest (medical decisionlevel) on very low or near zerovalues. | Class II SpecialControls GuidanceSection 10 -Performance | Standards DocumentsValidation, Verification, and QualityAssurance of Automated HematologyAnalyzers, Approved Standard – 2ndEdition; June 2010; CLSI H26-A2(FDA Standards Recognition # 7-210)Protocols for Determination of Limitsof Detection and Limits ofQuantitation; CLSI EP17-A(FDA Standards Recognition # 7-194) | Analysis of the data collecteddemonstrates that the updated DxH800 meets the performancerequirements for LoB, LLoD andLLOQ results (within acceptancelimits), for the WBC and PLTparameters in whole blood and theBF-TNC and BF-RBC parametersin body fluids. |
| Whole blood• WBC and PLTBody Fluid• TNC and RBC | ||||
| PerformanceClinicalSensitivity andSpecificity | Clinical Sensitivity andSpecificity are used to assessthe ability of a test to detectpresence or absence of acondition/abnormality. For theupdated DxH 800, ClinicalSensitivity and Specificity wasused to assess the WBCDifferential Suspect messageflagging capability of thesystem. | Class II SpecialControls GuidanceSection 10 -Performance | Standards DocumentsValidation, Verification, and QualityAssurance of Automated HematologyAnalyzers, Approved Standard – 2ndEdition; June 2010; CLSI H26-A2(FDA Standards Recognition # 7-210)Reference Leukocyte (WBC)Differential Count (Proportional) andEvaluation of Instrumental Methods;CLSI H20-A2(FDA Standards Recognition # 7-165)Reference DocumentsThe International Consensus Group forHematology Review: SuggestedCriteria for Action FollowingAutomated CBC and WBC DifferentialAnalysis; Laboratory Hematology,11:83-90, 2005 | Analysis of the data collecteddemonstrates that the updated DxH800 provided equivalent orimproved performance for ClinicalSensitivity and Specificity ascompared to the predicate deviceanalyzing the same data set. |
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| Study | Testing Approach | FDA GuidanceDocuments | Standards / References | 510(k) Testing Summary |
|---|---|---|---|---|
| LinearityWhole blood andBody fluid | Testing was performed on theupdated DxH 800 todemonstrate the linearity ofthe device. Linearity wasassessed by demonstrating thatthe reported results aredirectly proportional to theconcentration of themeasurand in a test sample forwhole blood and body fluids. | Class II SpecialControls GuidanceSection 11 - Linearity | Standards DocumentsValidation, Verification, and QualityAssurance of Automated HematologyAnalyzers, Approved Standard - 2ndEdition; June 2010; CLSI H26-A2(FDA Standards Recognition # 7-210)Evaluation of the Linearity ofQuantitative Measurement; ApprovedGuideline; April 2003. CLSI EP06-A(FDA Standards Recognition #7-193) | Analysis of the data collecteddemonstrates that the updated DxH800 meets the performancerequirements and provides linearresults, within acceptance limits,for Whole blood and Body Fluid. |
| CarryoverWhole blood andBody fluid | Testing was performed todemonstrate whole blood andbody fluid carryoverperformance of the updatedDxH 800 by determining theimpact of a specimen havinghigh parameter valuespreceding a specimen withlow parameter values. Thistesting also serves substantiatethe modified NRBC carryoverclaim for the updated DxH800. | Class II SpecialControls GuidanceSection 12 -Carryover | Standards DocumentsValidation, Verification, and QualityAssurance of Automated HematologyAnalyzers, Approved Standard - 2ndEdition; June 2010; CLSI H26-A2(FDA Standards Recognition #7-210)Reference DocumentsGuidelines for the evaluation of bloodcell analyzers including those used fordifferential leukocyte and reticulocytecounting and cell marker applications.International Council forStandardization in Haematology:prepared by the ICSH expert panel oncytometry. Clin Lab Haematol,16(2):157-174, 1994. | Analysis of the data collecteddemonstrates that the updated DxH800 meets the whole blood andbody fluid carryover performancerequirements (within acceptancelimits), for the parametersmeasured. |
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| Study | SpecimensAnticoagulant | Testing Approach | FDA GuidanceDocuments | Standards / References | 510(k) Testing Summary |
|---|---|---|---|---|---|
| Testing was performed on theupdated DxH 800 todemonstrate equivalency ofresults for whole bloodspecimens collected into K₂and K₃EDTA and analyzedusing the CBC, Differentialand Retic analytical cycle. | Class II SpecialControls GuidanceSection 13 -Specimens | Standards DocumentsValidation, Verification, and QualityAssurance of Automated HematologyAnalyzers, Approved Standard - 2ndEdition; June 2010; CLSI H26-A2(FDA Standards Recognition # 7-210)Procedures for the Collection ofDiagnostic Blood Specimens byVenipuncture; Approved Standard -Sixth Edition; October 2007; CLSI H3-A6(FDA Standards Recognition # 7-201)Procedures and Devices for theCollection of Diagnostic CapillaryBlood Specimens; Approved Standard -Sixth Edition; September 2008; CLSIH04-A6(FDA Standards Recognition # 7-203)User Verification of Performance forPrecision and Trueness ApprovedGuideline; Approved Guideline -Second Edition; June 2005; CLSIEP15-A2(FDA Standards Recognition # 7-153)Reference DocumentsRecommendations of the InternationalCouncil for Standardization inHaematology forethylenediaminetetraacetic acidanticoagulation of blood for blood cellcounting and sizing. Am J Clin Path,100(4)371-372, 1993. | Analysis of the data collecteddemonstrates that the updated DxH800 meets performancerequirements and providescomparable results, for allparameters reported, fromspecimens collected into K₂ andK₃EDTA. |
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| Study | Testing Approach | FDA GuidanceDocuments | Standards / References | 510(k) Testing Summary |
|---|---|---|---|---|
| SpecimensCollectionmethod | Testing was performedon the updated DxH800 to demonstrateequivalency of results(within defined limits),for specimens collectedby venipuncture andcapillary collectionmethods and analyzedusing the CBC,Differential and Reticanalytical cycle. | Class II Special ControlsGuidanceSection 13 - Specimens | Standards DocumentsValidation, Verification, and QualityAssurance of Automated HematologyAnalyzers, Approved Standard - 2ndEdition; June 2010; CLSI H26-A2(FDA Standards Recognition # 7-210)Procedures for the Collection ofDiagnostic Blood Specimens byVenipuncture; Approved Standard - SixthEdition; October 2007; CLSI H3-A6(FDA Standards Recognition # 7-201)Procedures and Devices for the Collectionof Diagnostic Capillary BloodSpecimens; Approved Standard - SixthEdition; September 2008; CLSI H04-A6(FDA Standards Recognition # 7-203)User Verification of Performance forPrecision and Trueness ApprovedGuideline; Approved Guideline - SecondEdition; June 2005; CLSI EP15-A2(FDA Standards Recognition # 7-153) | Analysis of the data collecteddemonstrates that the updated DxH800 meets the performancerequirements and providescomparable results, for allparameters reported fromspecimens collected byvenipuncture and capillarycollection methods and analyzedusing the CBC, Differential andReticulocyte analytical cycle. |
| SpecimensStability | Testing was performedon the updated DxH800 to demonstratewhole blood specimenstability. Testing wasperformed on wholeblood specimens atvarious time intervals(long-term and short-term) and stored atrefrigerated and roomtemperature. In additiontesting was performedon pre-dilutedspecimens. | Class II Special ControlsGuidanceSection 13 - Specimens | Standards DocumentsNone | Analysis of the data collecteddemonstrates that the updated DxH800 meets the performancerequirements and claims withrespect to whole blood long term,short term and pre-dilute samplestability. |
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Section 5: 510(k) Summary - Updated
Page 20 of 22
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| Study | Testing Approach | FDA GuidanceDocuments | Standards / References | 510(k) Testing Summary |
|---|---|---|---|---|
| ReferenceRanges | Confirmatory testingwas performed on theupdated DxH 800 todemonstratecomparability of wholeblood reference rangesfor an adult populationto the rangesestablished for thepredicate device. | Class II Special ControlsGuidanceSection 14 - ReferenceValues | Standards DocumentsDefining, Establishing, and VerifyingReference Intervals in the ClinicalLaboratory; Approved Guideline – ThirdEdition. CLSI C28-A3 (FDA Standards Recognition # 7-202) | The reference ranges establishedfor the predicate DxH 800 areapplicable for the updated DxH800. The updated DxH 800labeling will provide the referenceranges as currently presented in thepredicate 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.
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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
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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
§ 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.”