(270 days)
Not Found
No
The document describes standard hematology analysis techniques (Coulter Principle, optical measurement, spectrophotometry) and mentions "Algorithms using dynamic gates" for data processing, which is typical for traditional hematology analyzers and does not indicate the use of AI/ML. There are no mentions of AI, ML, DNN, or image processing.
No
The device is an in vitro diagnostic (IVD) hematology analyzer used to identify normal versus abnormal blood parameters and requires additional studies for abnormal findings. It does not treat, cure, mitigate, or prevent disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The DxH 520 is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories and physician's office laboratories." This clearly designates it as a diagnostic device.
No
The device description clearly states it is an "instrument" and describes hardware components like impedance measurement, optical measurement (blue LED), spectrophotometry, and an embedded computer. It processes blood specimens using physical sampling methods.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The DxH 520 is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories and physician's office laboratories."
N/A
Intended Use / Indications for Use
The DxH 520 is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories and physician's office laboratories. It is used to identify the normal patient with normal system-generated parameters from patients with abnormal parameters and/or flags that require additional studies.
The DxH 520 identifies and enumerates the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, LY%, LY#, MO%, MO#, NE%, EO%, EO#, BA%, BA# in whole blood samples (venous and capillary) collected in K2EDTA and K3EDTA anticoagulants, and prediluted whole blood.
The instrument is for use in adult and pediatric populations, including neonates.
LIMITATIONS
All numerical results reported for Basophil count and percent values must be reflexed for manual microscopy or followed up for additional testing based on the laboratory's SOP.
Product codes
GKZ
Device Description
The DxH 520 instrument provides a complete blood count (CBC with Five Part Differential (5PD)). Blood specimens are processed using a Closed Vial sampling method as default and have the option to run as Open Vial per operator selection.
RBC, WBC and PLT cell counts and sizes are determined using the Coulter Principle (impedance). The WBC 5 part differential is determined using a combination of the impedance WBC data and the direct optical measurement (Axial Light Loss - ALL) using a blue LED focused through the WBC aperture. With the addition of the DxH 500 Series Lyse, the RBCs are lysed and the released hemoglobin is converted into stable Oxyhemoglobin (or Carboxyhemoglobin, if present). The resulting complex is then measured by spectrophotometry.
The data obtained from the counting, sizing, optical and hemoglobin measurements is processed to create the DxH 520 hematological measurement that the device reports. Raw information is digitized from all analytical modules and passed to an embedded computer processing. Algorithms using dynamic gates to differentiate WBC subpopulations and flagging are performed within the embedded computer.
Controls and calibrators are used to monitor the performance of the instrument.
The compact bench top design of the DxH 520 will benefit small laboratories where bench space is limited. The integrated color display with graphical icon based user interface is intended to facilitate ease of use and operator training. The small bench-top DxH 520 instrument utilizes fully featured integrated software usually found on larger instrumentation.
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
adult and pediatric populations, including neonates.
Intended User / Care Setting
clinical laboratories and physician's office laboratories.
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)
Measurement Procedure Comparison:
- TESTING APPROACH: To compare the results (CBC and differential values) from test instruments versus the predicate DxH800 at clinical sites and small laboratory / physician office laboratory sites. Comparison to manual microscopy as the reference method was performed for the WBC differential on the DxH 520.
- TESTING RESULTS: The results support the accuracy claims for all parameters. The data presented shows substantial equivalency of the CBC and DIFF parameters to the DxH 800 predicate system at large clinical laboratories that include cancer centers, and at small laboratories with less experienced operators. The DxH 520 is substantially equivalent to the reference method (manual slides) for the differential proportional parameters.
Precision:
- TESTING APPROACH: To assess precision of the DxH 520, three (3) studies were conducted: Long Term Precision - Clinical and Small Laboratory/POL Sites, Short term precision – Whole blood Repeatability, Short term precision - Pre-Dilute Repeatability. Also, to assess operator to operator variability testing in both whole blood and pre-dilute modes at physician office laboratories or small laboratories with multiple operators.
- TESTING RESULTS: The long term precision (repeatability and reproducibility) meets the requirements as specified for all parameters. All whole blood repeatability acceptance criteria for all parameters were met. All pre-dilute repeatability parameters met all requirements. The pre-dilute precision is highly dependent on the operator's preparation of the dilutions. The Operator to Operator Variability of pre-dilute and whole blood for between operator and within specimen are provided as performance characteristics only. The variability at small laboratories does not invalidate the results put forth by the instrument as the same users participated in the accuracy study where all specifications were met. The pre-analytical handling of samples in a POL setting provides accurate analysis on the DxH 520 and has low impact on operator variability.
Clinical Sensitivity:
- TESTING APPROACH: To assess the clinical sensitivity and specificity of the overall flagging on the DxH 520 as compared to the accepted reference method for differential determination, (manual slide counts).
- TESTING RESULTS: The false negative samples were reviewed by the Beckman Coulter Medical Director for their potential clinical impact. There were no FN's generated by blasts in this data set. Based on the Medical Director assessment none of the false negatives that occurred would have compromised patient diagnosis and treatment. The overall rate of FN was 13.5%.
Linearity:
- TESTING APPROACH: Demonstrating that the reported results are directly proportional to the concentration of the measurand in a test sample for WBC, RBC, HGB, and PLT.
- TESTING RESULTS: The WBC, RBC Hgb and Plt parameters met the linearity specifications.
Carryover:
- TESTING APPROACH: To verify carryover. Testing will be performed for WBC, RBC, HGB, and PLT only.
- TESTING RESULTS: All carryover testing for WBC, differential, RBC, PLT and Hgb meet the specification with 95% confidence on the upper limit.
Detection Capability (Limit Of Blank, Detection And Quantitation):
- TESTING APPROACH: To assess performance detection capability limits using precision profiles for Lower Limit of Detection (LLoD) and Lower Limit of Quantitation (LLOQ) for WBC, RBC, HGB and PLT measurands.
- TESTING RESULTS: Results for the detection capability of each instrument for the WBC, RBC, Hgb and Plt parameters were within the specifications.
Specimen Stability:
- TESTING APPROACH: To assess specimen stability, two studies were conducted: Long term specimen stability assessed the drift in sample value over time at controlled room temperature and at refrigerated temperature. Pre-dilute test case will determine the drift in diluted samples over 90 minutes.
- TESTING RESULTS: All parameters met the corresponding requirements for whole blood specimen stability at 8hrs and 24hrs. Results were within the specifications. All parameters met the corresponding requirements for Pre-dilute Stability claim of 15 minutes.
Interfering Substances:
- TESTING APPROACH: To determine the level of lipemia, bilirubin, leukocytes and hemoglobin that affects hematology results on the DxH 520.
- TESTING RESULTS: The concentrations indicated for Lipemia, Conjugated Bilirubin, Unconjugated Bilirubin and Hemoglobin are the highest concentrations that did not interfere with the CBC parameters. For Leucocytes, this is the highest concentration that did not interfere with the Hemoglobin parameter. Lipemia: 62.5 mg/dl, Conjugated Bilirubin: 40mg/dl, Unconjugated Bilirubin: 20mg/dl, Hemoglobin: 200 mg/dl, Leucocytes:100 x10^3/uL
Equivalency:
- TESTING APPROACH: To demonstrate pre-analytical and within instrument equivalency, three (3) studies were performed: Pre-Dilute vs. Whole Blood Sampling Modes, K2 and K3 EDTA anticoagulant tube types and site of draw (venous or capillary), All sampling modes (Cap Pierce, Open Vial and Tube Holder Open Vial).
- TESTING RESULTS: In all sampling modes, the results demonstrated equivalency for all parameters tested and performance was within the specifications of the instrument.
Reference Intervals:
- TESTING APPROACH: To establish the reference interval for adult males and adult females. Also establish the pediatric reference interval for males and females combined age 0 days - 21 years.
- TESTING RESULTS: The adult reference interval was established on the DxH520 system for all parameters and included in the product labeling and software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Sensitivity: Sensitivity of 86.5% and specificity of 68.7%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 23, 2019
Beckman Coulter Samy Puccio Staff Regulatory Affair Specialist 11800 SW 147th Ave Miami, Florida 33196-2500
Re: K181475
Trade/Device Name: DxH 520 Hematology Instrument Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: June 1, 2018 Received: June 4, 2018
Dear Samy Puccio:
This letter corrects our substantially equivalent letter of March 1, 2019.
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 and the limitations described below. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
The Office of In Vitro Diagnostics and Radiological Health has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Intended Use statement of the device's labeling:
1
All numerical results reported for Basophil count and percent values must be reflexed for manual microscopy or followed up for additional testing based on the laboratory's SOP.
Furthermore, the intended use/indication for use:
The DxH 520 is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories and physician's office laboratories. It is used to identify the normal patient with normal system-generated parameters from patients with abnormal parameters and/or flags that require additional studies.
The DxH 520 identifies and enumerates the following parameters: WBC, RBC, HGB, HCT, MCH, MCHC, RDW, RDW-SD, PLT, MPV, LY%, LY#, MO%, MO#, NE%, NE#, EO%, EO#, BA%, BA# in whole blood samples (venous and capillary) collected in K2EDTA and K3EDTA anticoagulants, and prediluted whole blood.
The instrument is for use in adult and pediatric populations, including neonates.
must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Timothy T. Stenzel -S
Timothy Stenzel, MD, PhD Director Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known) K181475
Device Name DxH 520 Hematology Instrument
Indications for Use (Describe)
The DxH 520 is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories and physician's office laboratories. It is used to identify the normal patient with normal system-generated parameters from patients with abnormal parameters and/or flags that require additional studies.
The DxH 520 identifies and enumerates the following parameters: WBC, RBC, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, LY%, LY#, MO%, MO#, NE%, NE#, EO%, BA# in whole blood samples (venous and capillary) collected in K2EDTA and K3EDTA anticoagulants, and prediluted whole blood.
The instrument is for use in adult and pediatric populations, including neonates.
LIMITATIONS
All numerical results reported for Basophil count and be reflexed for manual microscopy or followed up for additional testing based on the laboratory's SOP.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Image /page/4/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, resembling a stylized "B". To the right of the circle, the words "BECKMAN" and "COULTER" are written in bold, black letters, with "BECKMAN" on the top line and "COULTER" on the bottom line. The logo is clean and professional, suggesting a company in the technology or science sector.
DxH 520
Section 5
510(k) Summary
5
510(k) Summary for DxH 520 Hematology Instrument
510(k) Owner / Submitter Information
Name: Beckman Coulter Inc. Address: 11800 SW 147th Ave., Miami, FL 33196 Phone #: (305) 380-4509 Fax #: (786) 639-2584 Contact Person: Samy Puccio Email Address: spuccio@beckman.com
Date Submitted: June 1, 2018
Device Name and Classification
Trade Name: DxH 520 Hematology Instrument Common Name: DxH 520 Classification: Class II Classification Name: Automated differential cell counter (21 CFR 864.5220) Product Code: GKZ Panel: Hematology
Predicate Device Information
| Predicate Product | 510(k)
Number | Date
Cleared | Classification | 21 CFR | Product
Code |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------------|----------------|----------|-----------------|
| UniCel® DxH 800
Coulter® Cellular
Analysis System | K140911 | 09/05/2014 | Class II | 864.5220 | GKZ |
| Manually prepared
blood films per
the manual wedge-
pull film technique as
described in CLSI
H20-A2, Reference
Leukocyte (WBC)
Differential Count
(Proportional) and
Evaluation of
Instrument Methods;
Approved Standard –
Second Edition | N/A | N/A | N/A | N/A | N/A |
6
Device Description
The DxH 520 instrument provides a complete blood count (CBC with Five Part Differential (5PD)). Blood specimens are processed using a Closed Vial sampling method as default and have the option to run as Open Vial per operator selection.
Image /page/6/Picture/2 description: The image shows a medical device, specifically a hematology analyzer, which is used for counting and characterizing blood cells. The device has a screen displaying an image of blood cells, and the name "DxH 520" is visible on the front. A barcode scanner is connected to the device, and there is a slot for inserting samples for analysis.
RBC, WBC and PLT cell counts and sizes are determined using the Coulter Principle (impedance). The WBC 5 part differential is determined using a combination of the impedance WBC data and the direct optical measurement (Axial Light Loss - ALL) using a blue LED focused through the WBC aperture. With the addition of the DxH 500 Series Lyse, the RBCs are lysed and the released hemoglobin is converted into stable Oxyhemoglobin (or Carboxyhemoglobin, if present). The resulting complex is then measured by spectrophotometry.
The data obtained from the counting, sizing, optical and hemoglobin measurements is processed to create the DxH 520 hematological measurement that the device reports. Raw information is digitized from all
analytical modules and passed to an embedded computer processing. Algorithms using dynamic gates to differentiate WBC subpopulations and flagging are performed within the embedded computer.
Controls and calibrators are used to monitor the performance of the instrument.
The compact bench top design of the DxH 520 will benefit small laboratories where bench space is limited. The integrated color display with graphical icon based user interface is intended to facilitate ease of use and operator training. The small bench-top DxH 520 instrument utilizes fully featured integrated software usually found on larger instrumentation.
Intended use
The DxH 520 is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories and physician's office laboratories. It is used to identify the normal patient with normal system-generated parameters from patients with abnormal parameters and/or flags that require additional studies.
7
The DxH 520 identifies and enumerates the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, LY%, LY#, MO%, MO#, NE%, EO%, EO#, BA%, BA# in whole blood samples (venous and capillary) collected in K2EDTA and K3EDTA anticoagulants, and prediluted whole blood.
The instrument is for use in adult and pediatric populations, including neonates.
LIMITATIONS
All numerical results reported for Basophil count and percent values must be reflexed for manual microscopy or followed up for additional testing based on the laboratory's SOP.
Technological Characteristics Comparisons to Predicate
The tables below describe the similarities and differences between the predicate device, the DxH 800 Cellular Analysis System, and the DxH 520 Hematology Instrument.
8
| Characteristic | UniCel DxH800
Predicate | DxH 520 | Similarity / Difference |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
and Function | 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 | The DxH 520 is a quantitative, multi-parameter,
automated hematology analyzer for in vitro
diagnostic use in clinical laboratories; including
hospital, reference, and physician's office
laboratories. It is used to identify the normal patient
with normal system-generated parameters from
patients with abnormal parameters and/or flags that
require additional studies.
The DxH 520 Analyzer identifies and enumerates
the measurands listed 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# Pre-Diluted 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# The instrument is for use in adult and pediatric
populations, including neonates.
LIMITATIONS
All numerical results reported for Basophil count
and percent values must be reflexed for manual
microscopy or followed up for additional testing
based on the laboratory's SOP. | The indications for use statements are
the
same for the CBC and 5 part differential
Analysis measurands.
By design, the DxH 520 does not
enumerate Reticulocytes or NRBC on
whole
blood, nor perform analysis of Body
Fluid
specimens.
By design, the DxH 520 enumerates
WBC differential measurands on
predilute
sample types while the predicate
does not. |
Table 1 - Intended Use and Function Similarities
9
| Characteristic | UniCel DxH800
Predicate | DxH 520 | Similarity / Difference | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Principles of Measurement | | | | |
| WBC, RBC, MCV,
Platelet | Aperture impedance (Coulter® Principle) | Aperture impedance (Coulter® Principle) | Same as predicate | |
| Hemoglobin | Spectrophotometric | Spectrophotometric | Same as predicate | |
| WBC Differential | VCSn Technology using :
• Aperture impedance (DC)
• Conductivity (RF)
• Laser Light Scatter (Multiple
angles)
• Laser Light Absorbance | Optical / Impedance
• Aperture impedance (DC)
• Light Absorbance (LED) -Axial Light
Lost | The measurement methods of the DxH
520 are similar to the predicate.
The DxH 520 only uses impedance
and Light absorbance in the WBC
Differential measure. The light source
for the optical method is an LED
The light source for DxH 800 optical is a
Laser | |
| Reticulocytes | VCSn Technology using :
• Aperture impedance (DC)
• Conductivity (RF)
• Laser Light Scatter (Multiple
angles)
• Laser Light Absorbance | N/A | DxH 520 does not enumerate
Reticulocytes | |
| NRBC | VCSn Technology using :
• Aperture impedance (DC)
• Conductivity (RF)
• Laser Light Scatter (Multiple
angles)
• Laser Light Absorbance | N/A | DxH 520 does not enumerate
Reticulocytes | |
Table 2 - Principles of Measurement Similarities
10
Table 3 - Reagents Similarities
| Characteristic | UniCel DxH800
Predicate | DxH 520 | Similarity / Difference |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagents | | | |
| Analysis
Reagents | COULTER® DxH Diluent
COULTER® DxH Diff Pack
COULTER® DxH Cell Lyse
COULTER® DxH Retic Pack
COULTER® DxH Cleaner | DxH 500 Series Diluent
DxH 500 Series Lyse
DxH 500 Series Cleaner | Coulter DxH Diluent and DxH 500 Series
Diluent have different formulation.
DxH 500 Series Lyse performs the functions
of DxH Diff Pack and DxH Cell Lyse, i.e.
lyse RBC's, convert HGB to stable pigment
and maintain WBC's for counting and
differential analysis.
COULTER® DxH Cleaner and DxH 500
Series Cleaner have the same formulation
DxH Retic- N/A since DxH 520 does not
enumerate reticulocytes |
| 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 | DxH 500 Series Control
DxH 500 Series Calibrator
DxH 500 Linearity Kit | The control and calibrator products both use
human and animal cells to simulate human
cell populations; each product is optimized
for the reagents and technology used.
Linearity products both use human and
animal cells to simulate human cell
populations.
DxH 520 does not require products
equivalent to the Latron, Retic and Body
Fluids controls.
DxH 520 cell control, calibrator and linearity
kit will have the same intended use as the
DxH products. |
| Table 4 - Pre-Analytical Features Similarities | | | |
| Characteristic | UniCel DxH800
Predicate | DxH 520 | Similarity / Difference |
| 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
PC based workstation running Microsoft
Windows XP application specific
software
Handheld Barcode Scanner
Printer | Bench top only
Integrated single board computer with color touch
screen running application specific software using
Linux OS
Handheld Barcode Scanner
Printer | Similar to predicate for the system
configuration of benchtop, barcode scanner
and printer
Different operating systems |
| Sampling
Mechanism | Single tube presentation - open and closed vial
sampling.
Automated presentation - closed vial sampling
from 5 position cassette; Maximum initial load
capacity 20 racks | Single tube manual open and closed vial | DxH 520 does not provide Automated
presentation |
| Mechanisms for
processing | 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. | Manual specimen mixing and presentation to the
analyzer, user initiated sample aspiration followed
by automatic sample preparation through sample
and reagent delivery
to the analytical modules, followed by data
collection, algorithmic processing and data
reporting | DxH 520 provides manual open and closed
vial
mechanisms for processing while
predicate provides additional
automated and closed vial sampling |
| 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 | Manual barcode scanning of sample tube identifier
(Handheld scanner) Manual keyboard entry of
sample
identifier | Automated: DxH 520 does not have
automated sample identification mechanisms
Manual sample identification same as
predicate |
| Characteristic | UniCel DxH800
Predicate | DxH 520 | Similarity / Difference |
| Sample Processing | | | |
| Aspiration
Pathway | Single sampling probe and common aspiration
pathway used for all sample presentation modes. | Single sampling probe for open and closed vial
processing and single aspiration pathway. | DxH 520 has open and closed sampling mode
with single aspiration pathway. |
| Sample
aspiration
volume | Automatic, cap-piercing : 165 μL
Single tube - open-vial and cap pierce:165 μL | Single tube - open and closed vial 16.7 μL | DxH 520 aspirates the same volume for open
and closed vial |
| | Pre-dilute 165 μL - fixed ratio of 1 in 5 dilution of
blood with diluent | Pre-dilute 20μL whole blood + 300 μL diluent | |
| 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
(Throughput is based on normal specimens -
analytical cycle times are increased with cytopenic
specimens) | 55 Samples per hour in CP mode
60 Samples per hour in OV mode | Different throughput and processing types
and rates for the DxH 520 and predicate |
| Data reporting | Workstation display graphics, hardcopy
printing and transmission to Laboratory
Information System (LIS) | Display of graphics, hardcopy printing and
transmission to
Laboratory Information System (LIS) | Same as predicate |
11
Table 4 - Pre-Analytical Features Similarities
12
Table 5 - Sample Processing Similarities
13
| | UniCel DxH800
Predicate | DxH 520 | Similarity / Difference |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | System Control | | |
| Controlling
software | System software (embedded and workstation)
designed specific to
support all features of DxH 800. 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.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 collectionSingle sampling
probe and common aspiration pathway
used for all sample presentation modes. | System software designed specific to support all
features of DxH 520 and DxH 500.
The Software runs on an integrated single board
computer with color touch screen using Linux OS.
Software provides all functions required for the
User Interface, Data analysis, Results management,
Instrument control and monitoring | DxH 520 software is designed with
architecture to provide similar functions and
capability as the DxH 800 within the DxH
520 design and architecture. |
Table 6 - System Control Similarities
14
| STUDY | TESTING APPROACH | FDA GUIDANCE
DOCUMENTS | STANDARDS/REFERENCES | TESTING RESULTS |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement Procedure
Comparison | To compare the results (CBC
and differential values) from
test instruments versus the
predicate DxH800 at clinical
sites and small laboratory /
physician office laboratory
sites.
Comparison to manual
microscopy as the reference
method was performed for the
WBC differential on the DxH
520 | Special Controls Guidance
Document: Premarket
Notifications for Automated
Differential Cell Counters
for Immature or Abnormal
Blood Cells - Accuracy
(Section 8) | CLSI H26-A2 Validation
Verification and Quality
Assurance of Automated
Hematology Analyzers - June
2010. FDA Standards
Recognition # 7-210
CLSI H20-A2 Reference
Leukocyte (WBC) Differential
Count (Proportional) and
Evaluation of Instrumental
Methods; Approved standard -
Second Edition January 2007.
FDA Standards Recognition #7-
165
CLSI GP41-A6 Procedures for
the Collection of Diagnostic
Blood Specimens by
Venipuncture; Approved
Standard-Sixth Edition. October
2007. FDA Standards
Recognition # 7-201
CLSI GP42-A6 Procedures and
Devices for the Collection of
Diagnostic Capillary Blood
Specimens; Approved Standard-
Sixth Edition. September 2008.
FDA Standards Recognition # 7-
203 | The results support the
accuracy claims for all
parameters. The data
presented shows
substantial equivalency of
the CBC and DIFF
parameters to the DxH 800
predicate system at large
clinical laboratories that
include cancer centers, and
at small laboratories with
less experienced operators.
The DxH 520 is
substantially equivalent to
the reference method
(manual slides) for the
differential proportional
parameters. |
| Precision | To assess precision of the DxH
520, three (3) studies were
conducted: | Special Controls Guidance
Document: Premarket
Notifications for Automated
Differential Cell Counters
for Immature or Abnormal
Blood Cells - Precision | CLSI H26-A2 Validation
Verification and Quality
Assurance of Automated
Hematology Analyzers - June
2010. FDA Standards
Recognition # 7-210 | The long term precision
(repeatability and
reproducibility) meets the
requirements as specified
for all parameters |
| STUDY | TESTING APPROACH | FDA GUIDANCE
DOCUMENTS | STANDARDS/REFERENCES | TESTING RESULTS |
| | Long Term Precision - Clinical
and Small Laboratory/POL
Sites,
Short term precision – Whole
blood Repeatability,
Short term precision - Pre-
Dilute Repeatability. | (Section 9) | CLSI EP05-A3 Evaluation of
Precision Quantitative
Measurement Procedures-Third
Edition. September 2014. FDA
Standards Recognition # 7-251
CLSI H20-A2 Reference
Leukocyte (WBC) Differential
Count (Proportional) and
Evaluation of Instrumental
Methods; Approved standard -
Second Edition January 2007.
FDA Standards Recognition #7-
165 | All whole blood
repeatability acceptance
criteria for all parameters
were met.
All pre-dilute repeatability
parameters met all
requirements. The pre-
dilute precision is highly
dependent on the
operator's preparation of
the dilutions. |
| Precision | To assess operator to operator
variability testing in both whole
blood and pre-dilute modes at
physician office laboratories or
small laboratories with multiple
operators. | Special Controls Guidance
Document: Premarket
Notifications for Automated
Differential Cell Counters
for Immature or Abnormal
Blood Cells - Precision
(Section 9) | No applicable standards. | The Operator to Operator
Variability of pre-dilute
and whole blood for
between operator and
within specimen are
provided as performance
characteristics only. The
variability at small
laboratories does not
invalidate the results put
forth by the instrument as
the same users participated
in the accuracy study
where all specifications
were met. The pre-
analytical handling of
samples in a POL setting
provides accurate analysis
on the DxH 520 and has
low impact on operator
variability. |
| Clinical Sensitivity | To assess the clinical sensitivity
and specificity of the overall | Special Controls Guidance
Document: Premarket | CLSI H26-A2 Validation
Verification and Quality | The false negative samples
were reviewed by the |
| STUDY | TESTING APPROACH | FDA GUIDANCE
DOCUMENTS | STANDARDS/REFERENCES | TESTING RESULTS |
| | flagging on the DxH 520 as
compared to the accepted
reference method for
differential determination,
(manual slide counts). | Notifications for Automated
Differential Cell Counters
for Immature or Abnormal
Blood Cells - Performance
(Section 10) | Assurance of Automated
Hematology Analyzers - June
2010. FDA Standards
Recognition # 7-210
CLSI H20-A2 Reference
Leukocyte (WBC) Differential
Count (Proportional) and
Evaluation of Instrumental
Methods; Approved standard -
Second Edition January 2007.
FDA Standards Recognition #7-
165
CLSI EP12-A2 User Protocol for
Evaluation of Qualitative Test
Performance, Approved
Guideline – 2nd Edition. FDA
Standards Recognition # 7-152
CLSI GP41-A6 Procedures for
the Collection of Diagnostic
Blood Specimens by
Venipuncture; Approved
Standard-Sixth Edition. October
2007. FDA Standards
Recognition # 7-201
CLSI GP42-A6 Procedures and
Devices for the Collection of
Diagnostic Capillary Blood
Specimens; Approved Standard-
Sixth Edition. September 2008.
FDA Standards Recognition # 7-
203 | Beckman Coulter Medical
Director for their potential
clinical impact. There were
no FN's generated by
blasts in this data set.
Based on the Medical
Director assessment none
of the false negatives that
occurred would have
compromised patient
diagnosis and treatment.
The overall rate of FN was
13.5% with a sensitivity of
86.5% and specificity of
68.7%. |
| Linearity | Demonstrating that the reported
results are directly proportional
to the concentration of the | Special Controls Guidance
Document: Premarket
Notifications for | CLSI H26-A2 Validation
Verification and Quality
Assurance of Automated | The WBC, RBC Hgb and
Plt parameters met the
linearity specifications. |
| STUDY | TESTING APPROACH | FDA GUIDANCE
DOCUMENTS | STANDARDS/REFERENCES | TESTING RESULTS |
| | measurand in a test sample for
WBC, RBC, HGB, and PLT. | Automated Differential
Cell Counters for
Immature or Abnormal
Blood Cells - Linearity
(Section 11) | Hematology Analyzers - June
2010. FDA Standards
Recognition # 7-210
CLSI EP06-A, Evaluation of the
Linearity of Quantitative
Measurement Procedures: A
Statistical Approach; 1st Edition.
FDA Standards Recognition # 7-
193 | |
| Carryover | To verify carryover. Testing
will be performed for WBC,
RBC, HGB, and PLT only. | Special Controls Guidance
Document: Premarket
Notifications for Automated
Differential Cell Counters
for Immature or Abnormal
Blood Cells - Carryover
(Section 12) | CLSI H26-A2 Validation
Verification and Quality
Assurance of Automated
Hematology Analyzers - June
2010. FDA Standards
Recognition # 7-210 | All carryover testing for
WBC, differential, RBC,
PLT and Hgb meet the
specification with 95%
confidence on the upper
limit. |
| Detection Capability
(Limit Of Blank,
Detection And
Quantitation) | To assess performance
detection capability limits using
precision profiles for Lower
Limit of Detection (LLoD) and
Lower Limit of Quantitation
(LLOQ) for WBC, RBC, HGB
and PLT measurands. | None | CLSI H26-A2 Validation
Verification and Quality
Assurance of Automated
Hematology Analyzers - June
2010. FDA Standards
Recognition # 7-210
CLSI EP17-A2 Evaluation of
Detection Capability for Clinical
Laboratory measurement
Procedures; Approved Guideline-
second Edition. June 2012. FDA
Standards Recognition #7-233 | Results for the detection
capability of each
instrument for the WBC,
RBC, Hgb and Plt
parameters were within the
specifications. |
| Specimen Stability | To assess specimen stability,
two studies were conducted:
Long term specimen stability
assessed the drift in sample
value over time at controlled
room temperature and at
refrigerated temperature. | None | CLSI H26-A2 Validation
Verification and Quality
Assurance of Automated
Hematology Analyzers - June
2010. FDA Standards
Recognition # 7-210 | All parameters met the
corresponding
requirements for whole
blood specimen stability at
8hrs and 24hrs. Results
were within the
specifications. |
| STUDY | TESTING APPROACH | FDA GUIDANCE
DOCUMENTS | STANDARDS/REFERENCES | TESTING RESULTS |
| | Pre-dilute test case will
determine the drift in diluted
samples over 90 minutes. | | CLSI EP25-A Evaluation of
Stability of In Vitro Diagnostic
Reagents, 1st Edition. FDA
Standards Recognition # 7-235 | All parameters met the
corresponding
requirements for Pre-dilute
Stability claim of 15
minutes. |
| Interfering Substances | To determine the level of
lipemia, bilirubin, leukocytes
and hemoglobin that affects
hematology results on the DxH
520. | None | CLSI H26-A2 Validation
Verification and Quality
Assurance of Automated
Hematology Analyzers - June
2010. FDA Standards
Recognition # 7-210
C56-A Hemolysis, Icterus, and
Lipemia/Turbidity Indices as
Indicators of Interference in
Clinical Laboratory Analysis;
Approved Guideline July 2012.
FDA Standards Recognition # 7-
242 | The concentrations
indicated for Lipemia,
Conjugated Bilirubin,
Unconjugated Bilirubin
and Hemoglobin are the
highest concentrations that
did not interfere with the
CBC parameters. For
Leucocytes, this is the
highest concentration that
did not interfere with the
Hemoglobin parameter.
Lipemia: 62.5 mg/dl
Conjugated Bilirubin:
40mg/dl
Unconjugated Bilirubin:
20mg/dl
Hemoglobin: 200 mg/dl
Leucocytes:100 x103/uL |
| Equivalency | To demonstrate pre-analytical
and within instrument
equivalency, three (3) studies
were performed:
Pre-Dilute vs. Whole Blood
Sampling Modes | None | CLSI H26-A2 Validation
Verification and Quality
Assurance of Automated
Hematology Analyzers - June
2010. FDA Standards
Recognition # 7-210 | In all sampling modes, the
results demonstrated
equivalency for all
parameters tested and
performance was within
the specifications of the
instrument. |
| | K2 and K3 EDTA
anticoagulant tube types and | | CLSI GP41-A6 Procedures for
the Collection of Diagnostic | |
| STUDY | TESTING APPROACH | FDA GUIDANCE
DOCUMENTS | STANDARDS/REFERENCES | TESTING RESULTS |
| | site of draw (venous or
capillary)
All sampling modes (Cap
Pierce, Open Vial and Tube
Holder Open Vial) | | Blood Specimens by
Venipuncture; Approved
Standard-Sixth Edition. October
2007. FDA Standards
Recognition # 7-201
CLSI GP42-A6 Procedures and
Devices for the Collection of
Diagnostic Capillary Blood
Specimens; Approved Standard-
Sixth Edition. September 2008.
FDA Standards Recognition # 7-
203 | |
| Reference Intervals | To establish the reference
interval for adult males and
adult females. Also establish
the pediatric reference interval
for males and females
combined age 0 days - 21
years. | Special Controls Guidance
Document: Premarket
Notifications for
Automated Differential
Cell Counters for
Immature or Abnormal
Blood Cells - Reference
Values (Section 14) | EP28-A3c, Defining,
Establishing, and Verifying
Reference Intervals in the
Clinical Laboratory; Approved
Guideline - Third Edition.
October 2010. FDA Standards
Recognition # 7-224 | The adult reference
interval was established on
the DxH520 system for all
parameters and included in
the product labeling and
software. |
Table 7 – Performance Summary
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