(156 days)
Not Found
No
The document describes a standard automated hematology analyzer and a specific parameter (MDW) for sepsis indication. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The MDW parameter is described as a quantitative measurement, not an output of an AI/ML model.
No
The device is an in vitro diagnostic (IVD) device used for screening patient populations and aiding in the identification of sepsis, not for treating or preventing disease.
Yes
This device is an in vitro diagnostic (IVD) device used for screening patient populations in clinical laboratories by identifying and enumerating various blood parameters. It also aids in identifying patients with sepsis, which is a diagnostic function.
No
The device description explicitly states the system consists of two primary components: the workstation and the DxH 800 analyzer. The analyzer is a hardware component that processes samples.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automatology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories."
- Device Description: The "Device Description" section also states: "The DxH 800 System is a quantitative, automated hematology analyzer designed for in vitro diagnostic use in screening patient populations by clinical laboratories."
- Nature of the Tests: The device performs quantitative measurements of various blood parameters (WBC, RBC, HGB, etc.) and body fluid parameters (TNC, RBC). These are laboratory tests performed on samples taken from the body, which is the definition of in vitro diagnostics.
- Intended Use: The intended use is for screening patient populations in clinical laboratories and aiding in the identification of sepsis in adult emergency department patients. These are diagnostic purposes.
N/A
Intended Use / Indications for Use
The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automatology 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%, BA%, BA#, NRBC%, NRBC%, RET%, RET#, MRV, IRF
Pre-Diluted Whole Blood (Venous and Capillary) - WBC, RBC, HGB, HCT, MCH, MCHC, RDW, RDW-SD, PLT, MPV
Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC
The Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application is the quantitative measurement of Monocyte Distribution Width (MDW). The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department, on whom a white cell differential test has been ordered.
MDW is measured from a (K2EDTA) whole-blood venous sample within 2 hours of collection. MDW values greater than 20.0 together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission.
MDW values greater than 20.0 should be interpreted in association with other clinical information and diagnostic testing, as a proportion of patients without sepsis may have an elevated MDW value at baseline.
MDW values less than or equal to 20.0 cannot rule out sepsis or the development of sepsis within 12 hours of hospital admission. The Early Sepsis Indicator should not be used as the sole basis to determine the absence of sepsis.
The predictive value of the Early Sepsis Indicator for identifying sepsis in patients with hematological abnormalities has not been established.
Product codes
GKZ, QFS
Device Description
This 510(k) submission is for the UniCel DxH 800 Coulter Cellular Analysis System (DxH 800) with software version 3.9.0.
The Early Sepsis Indicator (ESI) requires the use of the UniCel DxH 800 Coulter Cellular Analysis System (DxH 800) and its reagents, controls and calibrators last cleared under 510(k) K140911.
The DxH 800 System is a quantitative, automated hematology analyzer designed for in vitro diagnostic use in screening patient populations by clinical laboratories. The system provides a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic), Nucleated Red Blood Cell (NRBC) on whole blood, as well as, Total Nucleated Count (TNC), and Red Cell Count (RBC) on Body Fluids (cerebrospinal. serous and synovial). The DxH 800 also includes the Monocyte Distribution Width (MDW) parameter shown to aid in the early detection of Sepsis in emergency room adult patients.
The system consists of two primary components, the workstation and the DxH 800 analyzer as shown in Figure 1. DxH 800 System Configuration. The primary function of the DxH 800 analyzer is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing and storage and external communications. The analyzer runs embedded code and the workstation runs Microsoft Windows 7 Operating System (OS).
Optionally, the workstation can be connected to:
- A printer for creating reports;
- 0 A Laboratory Information System (LIS) for receiving test orders and releasing results; and
- Pro-Service Remote Management System (RMS) which provides secure access to ● the DxH800 workstation for BCI Service Personnel to perform troubleshooting, system monitoring and for assisting customers.
This modification to the DxH 800 is being implemented as part of corrective action for a field action initiated by Beckman Coulter (BEC) in July 2018. The field action was issued on the DxH instruments to notify customers that BEC received and confirmed reports of sporadic erroneously elevated platelet results without flags or system messages on some software versions of the UniCel DxH 800/600.
As part of an initial corrective action. BEC developed a software patch that contains an additional criterion to an existing algorithm flag in the software, alerting the user of a suspect PLT finding and to review the result. Upon further investigation, a root cause was identified as the sweep flow disruption that may occur following the "Clear RBC Apertures" procedure. Customers were informed to discontinue using this procedure and discontinue use of the analyzer if the instrument had a clogged aperture that would not clear. Customers were then instructed to contact Beckman Coulter Customer Support Center and request service.
The modification prompting a new submission is an update to the DxH 800 software included in version 3.9.0 and contains the following changes:
-
- The addition of a "T50" criteria to an existing rule (154) to detect erroneously elevated platelet results caused by sweep flow obstructions. The system message (PLT Inter:Debris) is displayed and the "R" (review) flag is added to the platelet results directing the user to review per instructions provided in the IFU.
-
- Disable Clear RBC Aperture Update (The software patch to address field action FA-33718-2). A software change to internal software table values to display an error when user selects to execute the Clear RBC Apertures cycle (preventing the hardware execution of the procedure).
-
- Strengthen cybersecurity. This includes enabling whitelisting to prevent unauthorized software from being installed, enabling Windows Firewall on all network cards to prevent unauthorized network traffic and a user option to secure data by encrypting the hard drive.
-
- Addition of Automated VCSn Optimization feature. A software change to verify the Latron CP-X control (beads) recovers within the limits and optimize the calibration factor of the VCSn module. The adjustment occurs only during the Daily Shutdown cycle and uses the ratio of five successful Latron CP-X runs to compute the calibration factor needed.
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 patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate substantially equivalence (SE), the following design performance verification analyses were performed and evaluated:
-
- Carryover
-
- Linearity
-
- Precision
-
- Method Comparison
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
April 16, 2020
Beckman Coulter Samy Puccio Staff Regulatory Affair Specialist 11800 SW 147th Ave Miami, Florida 33196-2500
Re: K193124
Trade/Device Name: Unicel DxH 800 Coulter Cellular Analysis System, Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ, QFS Dated: November 7, 2019 Received: November 12, 2019
Dear Samy Puccio:
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. 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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193124
Device Name
Unicel DxH 800 Coulter Cellular Analysis System Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application
Indications for Use (Describe)
The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automatology 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%, BA%, BA#, NRBC%, NRBC%, RET%, RET#, MRV, IRF
Pre-Diluted Whole Blood (Venous and Capillary) - WBC, RBC, HGB, HCT, MCH, MCHC, RDW, RDW-SD, PLT, MPV
Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC
The Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application is the quantitative measurement of Monocyte Distribution Width (MDW). The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department, on whom a white cell differential test has been ordered.
MDW is measured from a (K2EDTA) whole-blood venous sample within 2 hours of collection. MDW values greater than 20.0 together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission.
MDW values greater than 20.0 should be interpreted in association with other clinical information and diagnostic testing, as a proportion of patients without sepsis may have an elevated MDW value at baseline.
MDW values less than or equal to 20.0 cannot rule out sepsis or the development of sepsis within 12 hours of hospital admission. The Early Sepsis Indicator should not be used as the sole basis to determine the absence of sepsis.
The predictive value of the Early Sepsis Indicator for identifying sepsis in patients with hematological abnormalities has not been established.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(k) Summary for Unicel DxH 800 Cellular Analysis System
510(k) Owner / Submitter Information
Company Name: Beckman Coulter Inc. Address: 11800 SW 147th Ave., Miami, FL 33196 Phone #: (305) 380-4509 Fax #: (786) 639-4156 Contact Person: Samy Puccio Email Address: spuccio@beckman.com
Date Submitted:
December 19, 2019
Device Information
Trade Name: Unicel DxH 800 Coulter Cellular Analysis System, Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application Common Name: DxH 800 Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification Name: Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis (21 CFR 866.3215) Classification: Class II (Special Controls) Product Code: GKZ, QFS Panel: Hematology, Microbiology
Predicate Device Information
| Predicate Product | 510(k)
Number | Date Cleared | Classification | 21 CFR | Product
Code |
|--------------------------------------------------------------------------------------------------------|------------------|--------------|----------------|----------------------|-----------------|
| Unicel DxH 800
Coulter Cellular
Analysis System | K140911 | Sept 5, 2014 | Class II | 864.5220 | GKZ |
| Unicel DxH 800
Coulter Cellular
Analysis System
with Early Sepsis
Indicator
Application | K181599 | Mar 18, 2019 | Class II | 864.5220
866.3215 | GKZ
QFS |
5
UniCel DxH 800 Coulter Cellular Analysis System and Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application
This 510(k) submission is for the UniCel DxH 800 Coulter Cellular Analysis System (DxH 800) with software version 3.9.0.
The Early Sepsis Indicator (ESI) requires the use of the UniCel DxH 800 Coulter Cellular Analysis System (DxH 800) and its reagents, controls and calibrators last cleared under 510(k) K140911.
The DxH 800 System is a quantitative, automated hematology analyzer designed for in vitro diagnostic use in screening patient populations by clinical laboratories. The system provides a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic), Nucleated Red Blood Cell (NRBC) on whole blood, as well as, Total Nucleated Count (TNC), and Red Cell Count (RBC) on Body Fluids (cerebrospinal. serous and synovial). The DxH 800 also includes the Monocyte Distribution Width (MDW) parameter shown to aid in the early detection of Sepsis in emergency room adult patients.
The system consists of two primary components, the workstation and the DxH 800 analyzer as shown in Figure 1. DxH 800 System Configuration. The primary function of the DxH 800 analyzer is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing and storage and external communications. The analyzer runs embedded code and the workstation runs Microsoft Windows 7 Operating System (OS).
Optionally, the workstation can be connected to:
- A printer for creating reports;
- 0 A Laboratory Information System (LIS) for receiving test orders and releasing results; and
- Pro-Service Remote Management System (RMS) which provides secure access to ● the DxH800 workstation for BCI Service Personnel to perform troubleshooting, system monitoring and for assisting customers.
Design Change Description:
This modification to the DxH 800 is being implemented as part of corrective action for a field action initiated by Beckman Coulter (BEC) in July 2018. The field action was issued on the DxH instruments to notify customers that BEC received and confirmed reports of sporadic erroneously elevated platelet results without flags or system messages on some software versions of the UniCel DxH 800/600.
As part of an initial corrective action. BEC developed a software patch that contains an additional criterion to an existing algorithm flag in the software, alerting the user of a suspect PLT finding and to review the result. Upon further investigation, a root cause
6
was identified as the sweep flow disruption that may occur following the "Clear RBC Apertures" procedure. Customers were informed to discontinue using this procedure and discontinue use of the analyzer if the instrument had a clogged aperture that would not clear. Customers were then instructed to contact Beckman Coulter Customer Support Center and request service.
The modification prompting a new submission is an update to the DxH 800 software included in version 3.9.0 and contains the following changes:
-
- The addition of a "T50" criteria to an existing rule (154) to detect erroneously elevated platelet results caused by sweep flow obstructions. The system message (PLT Inter:Debris) is displayed and the "R" (review) flag is added to the platelet results directing the user to review per instructions provided in the IFU.
-
- Disable Clear RBC Aperture Update (The software patch to address field action FA-33718-2). A software change to internal software table values to display an error when user selects to execute the Clear RBC Apertures cycle (preventing the hardware execution of the procedure).
-
- Strengthen cybersecurity. This includes enabling whitelisting to prevent unauthorized software from being installed, enabling Windows Firewall on all network cards to prevent unauthorized network traffic and a user option to secure data by encrypting the hard drive.
-
- Addition of Automated VCSn Optimization feature. A software change to verify the Latron CP-X control (beads) recovers within the limits and optimize the calibration factor of the VCSn module. The adjustment occurs only during the Daily Shutdown cycle and uses the ratio of five successful Latron CP-X runs to compute the calibration factor needed.
Intended Use/Indications for Use:
Unicel DxH 800 Coulter Cellular Analysis System (K140911)
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%, o NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF
Pre-Diluted Whole Blood (Venous and Capillary) -
o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV
Body Fluids (cerebrospinal, serous and synovial) -
TNC and RBC. .
7
Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application (K181599)
The UniCel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application is the quantitative measurement of Monocyte Distribution Width (MDW). The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department, on whom a white cell differential test has been ordered.
MDW is measured from a (K2EDTA) whole-blood venous sample within 2 hours of collection. MDW values greater than 20.0 together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission. MDW values greater than 20.0 should be interpreted in association with other clinical information and diagnostic testing, as a proportion of patients without sepsis may have an elevated MDW value at baseline.
MDW values less than or equal to 20.0 cannot rule out sepsis or the development of sepsis within 12 hours of hospital admission. The Early Sepsis Indicator should not be used as the sole basis to determine the absence of sepsis.
The predictive value of the Early Sepsis Indicator for identifying sepsis in patients with hematological abnormalities has not been established.
8
Comparison to Predicate:
The design changes applied to the DxH 800 serve as additional mitigations to existing risk control measures to the potential failure mode identified in the root cause analysis of the field action that initiated these changes.
These design changes do not impact the intended use or performance claims of the DxH 800.
| Characteristic | UniCel DxH 800 Coulter Cellular Analysis
System (K140911) and,
Unicel DxH 800 Coulter Cellular Analysis
System with Early Sepsis Indicator
Application (K181599) | Proposed Device |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use and
Function | K181599
The UniCel DxH 800 Coulter Cellular Analysis
System with Early Sepsis Indicator Application
is the quantitative measurement of Monocyte
Distribution Width (MDW). The Early Sepsis
Indicator is intended for use with adult patients
presenting to the emergency department, on
whom a white cell differential test has been
ordered.
MDW is measured from a (K2EDTA) whole-
blood venous sample within 2 hours of
collection. MDW values greater than 20.0
together with other laboratory findings and
clinical information, aids in identifying patients
with sepsis or at increased risk of developing
sepsis within the first 12 hours of hospital
admission.
MDW values greater than 20.0 should be
interpreted in association with other clinical
information and diagnostic testing, as a
proportion of patients without sepsis may have
an elevated MDW value at baseline.
MDW values less than or equal to 20.0 cannot
rule out sepsis or the development of sepsis
within 12 hours of hospital admission. The Early
Sepsis Indicator should not be used as the sole
basis to determine the absence of sepsis.
The predictive value of the Early Sepsis
Indicator for identifying sepsis in patients with
hematological abnormalities has not been
established.
K140911
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 | Same |
| Characteristic | UniCel DxH 800 Coulter Cellular Analysis
System (K140911) and,
Unicel DxH 800 Coulter Cellular Analysis
System with Early Sepsis Indicator
Application (K181599) | Proposed Device |
| | 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 | |
| Principles of Measurement | | |
| WBC, RBC, MCV,
PLT | Aperture impedance (Coulter® Principle) | Same |
| Hemoglobin | Spectrophotometric | Same |
| WBC Differential,
Reticulocytes,
NRBC, MDW | VCSn Technology using:
• Aperture impedance (DC)
• Conductivity (RF)
• Laser Light Scatter (Multiple angles)
• Laser Light Absorbance | Same |
| Reagents | | |
| Analysis Reagents | COULTER DxH Diluent
COULTER DxH Diff Pack
COULTER DxH Cell Lyse
COULTER DxH Retic Pack
COULTER DxH Cleaner | Same |
| Quality Control &
Calibrator | COULTER 6C Cell Control
Coulter 6C Plus Cell Control
COULTER Latron CP-X Control
COULTER RETIC-X Cell Control
COULTER LIN-X Control
COULTER Body Fluids Control
COULTER S-CAL Calibrator kit | Same |
| Pre-Analytic Features | | |
| Characteristic | UniCel DxH 800 Coulter Cellular Analysis
System (K140911) and,
Unicel DxH 800 Coulter Cellular Analysis
System with Early Sepsis Indicator
Application (K181599) | Proposed Device |
| System
configuration | PC based workstation running Microsoft
Windows XP application specific
software
Handheld Barcode Scanner
Printer | Same |
| 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 | Same |
| 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. | Same |
| Sample
identification | Sample aspiration module (SAM) mounted
barcode reader for automated barcode reading of
cassette and sample tube identifiers Manual
barcode scanning of sample tube identifier
(Handheld scanner) Manual keyboard entry of
sample identifier | Same |
| Sample Processing | | |
| Aspiration
Pathway | Single sampling probe and common aspiration
pathway used for all sample presentation modes. | Same |
| Sample
aspiration
volume | Automatic, cap-piercing: 165 µL
Single tube - open-vial and cap pierce: 165 µL
Pre-dilute 165 µL - fixed ratio of 1 in 5 dilution
of blood with diluent | Same |
| Throughput | For automatic mode:
• CBC at 100 specimens/hr.
• CBC and Differential at 100 specimens/hr.
• CBC and Differential with NRBC at 90
specimens/hr.
• Retic at 45 specimens/hr. | Same |
| Data reporting | Workstation display graphics, hardcopy
printing and transmission to Laboratory
Information System (LIS) | Same |
| System Control and Software | | |
| 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 | Same |
| Characteristic | UniCel DxH 800 Coulter Cellular Analysis
System (K140911) and,
Unicel DxH 800 Coulter Cellular Analysis
System with Early Sepsis Indicator
Application (K181599) | Proposed Device |
| | 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. | |
| Software Version | Version 3.8.0 | Version 3.9.0
Includes the additional
criteria for T50 Flag Disable Clear RBC
Aperture Strengthened
Cybersecurity Automated VCSn
Optimization |
Device Comparison Table:
9
10
11
12
Summary of Performance Testing:
To demonstrate substantially equivalence (SE), the following design performance verification analyses were performed and evaluated:
-
- Carryover
-
- Linearity
-
- Precision
-
- Method Comparison
Design Control Activities
The design development and verification/validation of the device modification have been performed under design control. The design control activities were based on risk analysis, and acceptance criteria were set to maintain the efficiency and safety of the device. Testing included design software verification testing, human factors and installation testing.
Substantial Equivalence Conclusion to Demonstrate Safety, Effectiveness & Equivalent Performance to Predicate:
The updates to the DxH 800 that are the subject of this submission, do not change the intended use, nor add or delete a contraindication for the device. The changes do not alter the device control mechanism, operating principle, energy type, environmental specification, ergonomics of the user interface, dimensional specifications, nor packaging.
The device does not have expiration dating nor is it subject to sterilization.
In summary, it can be concluded that the updated DxH 800, as described in this submission is substantially equivalent in terms of safety and effectiveness 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.