(149 days)
Not Found
No
The summary describes a standard automated hematology analyzer and slidemaker/stainer system with software for workcell configuration and data management. There is no mention of AI, ML, image processing for analysis, or any other indicators of AI/ML technology. The performance studies focus on standard analytical and system performance metrics.
No
The device is an in vitro diagnostic hematology analyzer used for screening and analysis, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "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." Additionally, the "Device Description" reiterates "The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories."
No
The device description clearly states that the system is comprised of physical hardware components (analyzers and slidemaker/stainers) that are physically connected and perform physical actions on biological samples. While software is mentioned as a key component for integration and control, the device is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
This statement clearly identifies the device's intended purpose as being for in vitro diagnostic use.
N/A
Intended Use / Indications 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#, 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) o TNC and RBC
The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The DxH 800 and DxH SMS form a family of integrated and interactive modular products that are scalable to meet the specific laboratory workflow and workload needs. Currently these products are offered as stand-alone devices only.
DxH 800: 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 Five-part Differential (Diff), Reticulocyte (RET), Nucleated Red Blood Cell (NRBC) on whole blood, Total Nucleated Count (TNC) and Red Blood Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial)
DxH SMS: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
The upgrade of these devices with software v3.0 will allow for these stand-alone devices to be configured into five workcell configurations through physical and virtual connections. Physically, the instruments are connected via hardware and the virtual connection is accomplished by means of the new control system software that provides integrated process control, data consolidation and sample transport to the various instruments in the workcell in order to facilitate and improve laboratory efficiency. This will yield a total of seven product configurations, including:
Stand-alone DxH 800 with software v3.0
Stand-alone DxH SMS with software v3.0
Five customizable workcell configurations comprised of DxH 800 and DxH SMS . with software v3.0
o DxH 801 - one DxH 800 + one DxH SMS
DxH 1600 two DxH 800
DxH 1601 two DxH 800 + one DxH SMS
DxH 2400 three DxH 800
o DxH 2401 three DxH 800 + one DxH SMS
These workcell configurations allow for increased system efficiencies through workload balancing between available instruments within the workcell, and automated pass through processing of selected slide preparation and stain test orders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electromagnetic Compatibility (EMC) Interference
Testing Approach: Verify that the EMC interference of individual DxH 800 instruments is not impacted when configured in a workcell configuration.
Testing Results: The analysis demonstrated that it is unlikely that EMC interference would be increased in the connected DxH workcell as compared to a stand-alone DxH 800.
Vibration Testing
Testing Approach: Verify that vibration introduced from interconnection of multiple DxH 800 and/or DxH SMS instruments in a workcell configuration does not impact the performance of the individual DxH 800 instruments.
Testing Results: The analysis demonstrated that it is unlikely that vibration in the connected DxH workcell would impact performance.
Measurement Procedure Comparison: Whole Blood and Body Fluids
Testing Approach: To evaluate bias between the test instruments versus the predicate DxH 800 v2.0.
Testing Results: Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the performance requirements for whole blood and body fluids bias when compared to the predicate device.
Imprecision (Repeatability): Whole Blood and Body Fluids
Testing Approach: To verify the imprecision (repeatability) of the DxH 800 meets performance specifications.
Testing Results: Analysis of the data collected demonstrates that the DxH 800 v3.0 meets performance requirements for repeatability for whole blood and body fluids.
Limits (LoB, LLoD, LLOQ)
Testing Approach: To verify that the DxH 800 meets the performance requirements for Limit of Blank (LoB), Lower Limit of Detection (LLoD), Lower Limit of Quantitation (LLOQ).
Testing Results: Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the performance requirements for LoB, LLoD, and LLOQ in whole blood and body fluids.
Linearity: Whole Blood and Body Fluids
Testing Approach: To verify linearity of WBC, RBC, Hgb and Plt parameters for whole blood and TNC and BF-RBC parameters for body fluids.
Testing Results: Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the linearity performance requirements for whole blood and body fluids.
Carryover: Whole Blood and Body Fluid
Testing Approach: To verify carryover for whole blood and body fluids on the DxH 800 meets performance specifications.
Testing Results: Analysis of the data collected demonstrates that the DxH 800 v3.0 meets the whole blood and body fluid carryover performance requirements.
Slide Quality
Testing Approach: To verify that the DxH SMS produces slides that meet the slide quality specifications.
Testing Results: The DxH SMS meets the performance requirements for slide quality.
Carryover
Testing Approach: To verify that the Carryover of the DxH SMS meets the performance specifications.
Testing Results: Analysis of the data collected demonstrates that the DxH SMS meets the performance requirements for blood smear carryover.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2014
BECKMAN COULTER, INC. C/O MR. BRENT LEMBERG STAFF REGULATORY AFFAIRS SPECIALIST 11800 SW 147TH AVE. MIAMI FL 33196
Re: K140911
Trade/Device Name: UniCel DxH 800 and DxH Slidemaker Stainer Coulter Cellular Analysis System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 4, 2014 Received: August 6, 2014
Dear Mr. Lemberg:
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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); 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
1
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 regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
UniCel® DxH 800 Coulter® Cellular Analysis System
Indications for Use (Describe)
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 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, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV
[ Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Maria MDChan -S
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments recarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31. 2017 See PRA Statement below.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration :
Indications for Use
510(k) Number (if known)
Device Name
UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System
Indications for Use (Describe)
The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Maria M. Chan -S
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
| Section 5 | 510(k) Summary |
|---|---|
| ----------- | ---------------- |
5
Page 2 of 14
510(k) Summary for UniCel® DxH 800 Coulter® Cellular Analysis System and UniCel DxH Slidemaker Stainer Coulter® Cellular Analysis System
510(k) Owner / Submitter Information
Name: Beckman Coulter Inc. Address: 11800 SW 147th Ave., Miami, FL 33196 Phone #: (305) 380-4509 Fax #: (305) 380-4344 Contact Person: Brent Lemberg Email Address: blemberg@beckman.com Date Submitted: April 10, 2014
Device Information
Trade Name: UniCel® DxH 800 Coulter® Cellular Analysis System Common Name: DxH 800 Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: GKZ Panel: Hematology
Trade Name: UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System Common Name: DxH SMS Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: GKZ Panel: Hematology
6
| Predicate Product | 510(k)
Number | Date
Cleared | Classification | 21 CFR | Product
Code |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------|----------------|----------|-----------------|
| UniCel® DxH 800 Coulter®
Cellular Analysis System | K120771 | March
22, 2013 | 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 |
Predicate Device Information
Device Description
The DxH 800 and DxH SMS form a family of integrated and interactive modular products that are scalable to meet the specific laboratory workflow and workload needs. Currently these products are offered as stand-alone devices only.
- . DxH 800: 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 Five-part Differential (Diff), Reticulocyte (RET), Nucleated Red Blood Cell (NRBC) on whole blood, Total Nucleated Count (TNC) and Red Blood Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial)
- . DxH SMS: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
7
Page 4 of 14
The upgrade of these devices with software v3.0 will allow for these stand-alone devices to be configured into five workcell configurations through physical and virtual connections. Physically, the instruments are connected via hardware and the virtual connection is accomplished by means of the new control system software that provides integrated process control, data consolidation and sample transport to the various instruments in the workcell in order to facilitate and improve laboratory efficiency. This will yield a total of seven product configurations, including:
- . Stand-alone DxH 800 with software v3.0
- Stand-alone DxH SMS with software v3.0 ●
- Five customizable workcell configurations comprised of DxH 800 and DxH SMS . with software v3.0
- o DxH 801 - one DxH 800 + one DxH SMS
- DxH 1600 two DxH 800 O
- DxH 1601 two DxH 800 + one DxH SMS O
- DxH 2400 three DxH 800 O
- o DxH 2401 three DxH 800 + one DxH SMS
These workcell configurations allow for increased system efficiencies through workload balancing between available instruments within the workcell, and automated pass through processing of selected slide preparation and stain test orders.
Intended Use:
DxH 800 Indications 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:
- 트 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#, MRV, IRF
- I Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV
- 트 Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC
8
DxH SMS Indications for Use:
The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
9
Page 6 of 14
Technological Characteristics Comparisons to Predicate
DxH 800 Device Comparison Table:
| Similarities | ||
|---|---|---|
| Characteristic | Predicate | |
| UniCel DxH 800 Software 2.0 | Device | |
| UniCel DxH 800 Software 3.0 | ||
| Indications 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) 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 | Same as predicate |
| Sampling
Mechanism | Single aspiration probe used for all sampling. Single tube presentation – open and closed vial sampling – specimen manually mixed Automated cassette presentation – closed vial sampling from five- position cassette
accepting a variety of defined specimen tubes. Cassette containing specimens mixed
prior to starting sampling and between specimens. Maximum initial load capacity 20 cassettes - System will continuously process cassettes
as added | Each DxH 800 in the workcell utilizes the
same sampling mechanism as the
predicate. |
10
Page 7 of 14
| Similarities | ||
|---|---|---|
| Characteristic | Predicate | |
| UniCel DxH 800 Software 2.0 | Device | |
| UniCel DxH 800 Software 3.0 | ||
| Mechanisms for | ||
| Processing | Mechanisms to achieve process of : | |
| o automated cassette transportation and specimen mixing (by rocking) | ||
| o sample aspiration | ||
| o sample preparation | ||
| o sample and reagent presentation to analytical modules | ||
| o sample analysis | ||
| o raw data collection | ||
| o algorithmic processing | ||
| o data reporting |
Specimen tube is in upright (cap up) position for closed vial sampling
Cassette transportation by magnetic drive allowing multi-directional moves and capability to
return cassette to sampling position for repeat / reflex testing | Each DxH 800 in the workcell utilizes the
same mechanisms for processing as the
predicate except:
In a connected configuration, specimen
transportation capability between multiple
DxH 800 analyzers. Repeat / reflex
testing can be done on different analyzer
than initial testing. |
| Data Analysis | Raw information is digitized from all analytical modules and passed to workstation for
algorithmic processing.
Algorithms using advanced mathematical methods for population differentiation and flagging
centralized within workstation | Same as Predicate |
| Data Reporting | Workstation display graphics, hardcopy printing and transmission to host Laboratory
Information System (LIS) | Same as Predicate |
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Page 8 of 14
| Similarities | ||
|---|---|---|
| Characteristic | Predicate | |
| UniCel DxH 800 Software 2.0 | Device | |
| UniCel DxH 800 Software 3.0 | ||
| Performance | ||
| Characteristics | The performance characteristics provided for: | |
| • Comparison of Measurement Procedures | ||
| • Whole Blood – CBC | ||
| • Whole Blood - Reticulocyte | ||
| • Whole Blood - Differential | ||
| • Whole Blood - NRBC | ||
| • Body Fluids | ||
| • Imprecision | ||
| • Whole Blood CBC, DIFF, Retic | ||
| • Prediluted Blood | ||
| • CSF, Serous, Synovial Body Fluid | ||
| • Linearity | ||
| • Carryover (High to Low) | ||
| • Whole Blood CBC, DIFF, Retic, NRBC, Body Fluids | Same as predicate with no changes to | |
| stated performance characteristics | ||
| Operating | ||
| Principles | Method of sample analysis | Same as predicate |
| Consumables | Reagents, controls, and calibrators utilized by the system | Same as predicate |
12
Page 9 of 14
| Differences | ||
|---|---|---|
| Characteristic | Predicate | |
| UniCel DxH 800 Software 2.0 | Device | |
| UniCel DxH 800 Software 3.0 | ||
| System | ||
| Configuration | Workcell configuration of one DxH 800 (stand-alone) Bench top 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 | Individual analyzers are same as predicate except | |
| analyzers can be connected creating multiple workcell | ||
| configurations (up to three DxH 800s and up to 1 DxH | ||
| SMS) |
Workcell configurations available only on a floor stand,
not on a bench top.
PC based workstation running Microsoft Windows 7
application specific software |
| Workstation | Software functionality to control sample processing as well as patient and
control data management | Each DxH 800 in the workcell utilizes the same
functionality as the predicate except one system
manager controls sample processing and management
for up to three DxH 800s plus one DxH SMS |
13
DxH SMS Device Comparison Table:
| Characteristic | Predicate
Manual Method
(H20-A2, Reference Leukocyte (WBC) Differential Count
(Proportional) and Evaluation of Instrumental Methods;
Approved Standard | Device
UniCel DxH Slidemaker Stainer Software 3.0 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Manual preparation of whole blood smears on microscopic
slides using a variety of fixatives, stains, buffers, and rinse
solutions. | The DxH Slidemaker Stainer is a fully automated slide
preparation and staining device that aspirates a whole
blood sample, smears a blood film on a clean microscope
slide, and delivers a variety of fixatives, stains, buffers,
and rinse solutions to that blood smear. |
| Device
Classification &
Product Code | Not applicable | 21 CFR 864.5220 Automated Cell Counter, GKZ |
| Manufacturer | Not applicable | Beckman Coulter |
| Specimen
Collection | Whole venous blood in EDTA | Same as predicate |
| Blood Film
Preparation | Manually prepared by technician | Automatically prepared by DxH SMS |
| Blood Film
Requirements | Section 6.3.1 of CLSI H20-A2 | Same as predicate |
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Page 11 of 14
Summary of DxH 800 Performance Testing
| Study | Testing Approach | FDA Guidance Documents | Standards/ References | Testing Results |
|---|---|---|---|---|
| Electromagnetic | ||||
| Compatibility | ||||
| (EMC) Interference | Verify that the EMC | |||
| interference of individual DxH | ||||
| 800 instruments is not impacted | ||||
| when configured in a workcell | ||||
| configuration. | None | None | The analysis demonstrated that it is unlikely that | |
| EMC interference would be increased in the | ||||
| connected DxH workcell as compared to a | ||||
| stand-alone DxH 800. | ||||
| Vibration Testing | Verify that vibration introduced | |||
| from interconnection of | ||||
| multiple DxH 800 and/or DxH | ||||
| SMS instruments in a workcell | ||||
| configuration does not impact | ||||
| the performance of the | ||||
| individual DxH 800 | ||||
| instruments. | None | None | The analysis demonstrated that it is unlikely that | |
| vibration in the connected DxH workcell would | ||||
| impact performance. | ||||
| Measurement | ||||
| Procedure | ||||
| Comparison: Whole | ||||
| Blood and Body | ||||
| Fluids | To evaluate bias between the | |||
| test instruments versus the | ||||
| predicate DxH 800 v2.0. | Special Controls Guidance | |||
| Document: Premarket | ||||
| Notifications for Automated | ||||
| Differential Cell Counters | ||||
| for Immature or Abnormal | ||||
| Blood Cells - Accuracy | ||||
| (Section 8) | · Validation, Verification, and | |||
| Quality Assurance of Automated | ||||
| Hematology Analyzers, Approved | ||||
| Standard - 2nd Edition; June 2010; | ||||
| CLSI H26-A2; FDA Standards | ||||
| Recognition # 7-210 | ||||
| · Measurement Procedure | ||||
| Comparison and Bias Estimation | ||||
| Using Patient Samples; Approved | ||||
| Guideline - Third Edition: CLSI | ||||
| EP9-A3; FDA Standards | ||||
| Recognition # 7-245 | Analysis of the data collected demonstrates that | |||
| the DxH 800 v3.0 meets the performance | ||||
| requirements for whole blood and body fluids | ||||
| bias when compared to the predicate device. | ||||
| Imprecision | ||||
| (Repeatability): | ||||
| Whole Blood and | ||||
| Body Fluids | To verify the imprecision | |||
| (repeatability) of the DxH 800 | ||||
| meets performance | ||||
| specifications. | Special Controls Guidance | |||
| Document: Premarket | ||||
| Notifications for Automated | ||||
| Differential Cell Counters | ||||
| for Immature or Abnormal | ||||
| Blood Cells - Precision | ||||
| (Section 9) | · Validation, Verification, and | |||
| Quality Assurance of Automated | ||||
| Hematology Analyzers, Approved | ||||
| Standard - 2nd Edition; June 2010; | ||||
| CLSI H26-A2; FDA Standards | ||||
| Recognition # 7-210 | Analysis of the data collected demonstrates that | |||
| the DxH 800 v3.0 meets performance | ||||
| requirements for repeatability for whole blood | ||||
| and body fluids. | ||||
| Study | Testing Approach | FDA Guidance Documents | Standards/ References | Testing Results |
| Limits (LoB, LLoD, | ||||
| LLOQ) | To verify that the DxH 800 | |||
| meets the performance | ||||
| requirements for Limit of Blank | ||||
| (LoB), Lower Limit of | ||||
| Detection (LLoD), Lower Limit | ||||
| of Quantitation (LLOQ). | None | • Validation, Verification, and | ||
| Quality Assurance of Automated | ||||
| Hematology Analyzers, Approved | ||||
| Standard - 2nd Edition; June 2010; | ||||
| CLSI H26-A2; FDA Standards | ||||
| Recognition #7-210 |
• Evaluation of Detection Capability
for Clinical Laboratory Measurement
Procedures; Approved Guideline -
Second Edition; CLSI EP17-A2;
FDA Standards Recognition #7-233 | Analysis of the data collected demonstrates that
the DxH 800 v3.0 meets the performance
requirements for LoB, LLoD, and LLoQ in
whole blood and body fluids. |
| Linearity: Whole
Blood and Body
Fluids | To verify linearity of WBC,
RBC, Hgb and Plt parameters
for whole blood and TNC and
BF-RBC parameters for body
fluids. | Special Controls Guidance
Document: Premarket
Notifications for Automated
Differential Cell Counters
for Immature or Abnormal
Blood Cells - Linearity
(Section 11) | • Validation, Verification, and
Quality Assurance of Automated
Hematology Analyzers, Approved
Standard - 2nd Edition; June 2010;
CLSI H26-A2; FDA Standards
Recognition #7-210
• Evaluation of the Linearity of
Quantitative Measurement
Procedures: A Statistical Approach;
Approved Guideline; April 2003.
CLSI EP06-A; FDA Standards
Recognition #7-193 | Analysis of the data collected demonstrates that
the DxH 800 v3.0 meets the linearity
performance requirements for whole blood and
body fluids. |
| Carryover: Whole
Blood and Body
Fluid | To verify carryover for whole
blood and body fluids on the
DxH 800 meets performance
specifications. | Special Controls Guidance
Document: Premarket
Notifications for Automated
Differential Cell Counters
for Immature or Abnormal
Blood Cells - Carryover
(Section 12) | • Validation, Verification, and
Quality Assurance of Automated
Hematology Analyzers, Approved
Standard - 2nd Edition; June 2010;
CLSI H26-A2; FDA Standards
Recognition #7-210 | Analysis of the data collected demonstrates that
the DxH 800 v3.0 meets the whole blood and
body fluid carryover performance requirements. |
| Study | Testing Approach | FDA Guidance Documents | Standards/ References | Testing Results |
| Slide Quality | To verify that the DxH SMS
produces slides that meet the
slide quality specifications. | None | CLSI H20-A2, Reference Leukocyte
(WBC) Differential Count
(Proportional) and Evaluation of
Instrumental Methods, Approved
Standard - Second Edition; FDA
Standards Recognition #7-165 | The DxH SMS meets the performance
requirements for slide quality. |
| Carryover | To verify that the Carryover of
the DxH SMS meets the
performance specifications. | None | None | Analysis of the data collected demonstrates that
the DxH SMS meets the performance
requirements for blood smear carryover. |
15
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Summary of DxH SMS Performance Testing:
17
Page 14 of 14
Substantial Equivalence Conclusion to Demonstrate Safety, Effectiveness & Equivalent Performance to Predicate:
The updates to the DxH 800 and DxH SMS with software v3.0 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.
The conclusions drawn from the performance testing discussed above demonstrate that the device is as safe, as effective, and meets the performance acceptance criteria.
In summary, the updated DxH 800 and DxH SMS with software v3.0, as described in this submission are substantially equivalent in terms of safety and effectiveness to their predicate device and reference method, respectively.
- The UniCel DxH 800 Coulter Cellular Analysis System v3.0 is substantially equivalent to ● the UniCel DxH 800 Coulter Cellular Analysis System v2.0 manufactured by Beckman Coulter.
- The UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System v3.0 is substantially equivalent to 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 Instrumental Methods; Approved Standard
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.