Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a flow cytometer and associated reagents and software for immunophenotyping. The data analysis software (Kaluza C) is described as a tool for manual analysis of listmode data with features like versatile plot displays and compensation options. There is no mention of AI or ML algorithms being used for data processing, interpretation, or classification. The analysis workflow is described as manual gating and interpretation by a pathologist.

Therapeutic

No
Explanation: The device is an in vitro diagnostic (IVD) device used for immunophenotyping and qualitative identification of cell populations to aid in the differential diagnosis of hematological neoplasms. It does not provide any treatment or therapy; it is solely for diagnostic purposes.

Diagnostic

Yes

The DxFLEX Flow Cytometer and its associated ClearLLab 10C Panels are explicitly stated as an "in vitro diagnostic device" and are intended for "qualitative identification of cell populations by multiparameter immunophenotyping" as an "aid in the differential diagnosis of hematologically abnormal patients." These functions clearly diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as the DxFLEX Flow Cytometer, DxFLEX Daily OC Fluorospheres, and various reagents. While it includes software (Kaluza C and CytExpert), it is part of a larger system that includes physical hardware and consumables.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device..." and "The ClearLab 10C Panels are intended for in vitro diagnostic use...".
Purpose of the Device: The device and its associated reagents are used to identify cell populations by multiparameter immunophenotyping as an aid in the differential diagnosis of hematologically abnormal patients. This is a diagnostic purpose performed in vitro (outside the body) on biological specimens.
Specimen Types: The device is used with peripheral whole blood, bone marrow, and lymph node specimens, which are biological samples commonly used in in vitro diagnostic testing.
Regulatory Context: The "Device Description" mentions that the ClearLLab 10C Reagent System is currently cleared on the Navios EX Flow cytometer under K183592, and this submission is to expand its use to the DxFLEX. K numbers are associated with FDA clearances for medical devices, including IVDs.
Performance Studies: The "Summary of Performance Studies" describes various tests (linearity, carryover, detection capability, precision, clinical accuracy) that are typical for demonstrating the performance of an IVD.

All these points strongly indicate that the DxFLEX Flow Cytometer and the ClearLLab 10C Reagent System, when used together as described, are intended for in vitro diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

The ClearLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios, Navios EX and DxFLEX flow cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.

These reagents provide multiparameter, qualitative results for the surface antigens listed below:

ClearLLab 10C B Cell Tube: Kappa, Lambda, CD10, CD5, CD200, CD34, CD38, CD20, CD19, CD45
ClearLLab 10C T Cell Tube: TCRy6, CD4, CD2, CD56, CD5, CD34, CD3, CD8, CD7, CD45
ClearLLab 10C M1 Cell Tube: CD16, CD7, CD10, CD13, CD64, CD34, CD14, HLA-DR, CD11b, CD45
ClearLLab 10C M2 Cell Tube: CD15, CD123, CD117, CD13, CD33, CD34, CD38, HLA-DR, CD19, CD45

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

OYE, PWD

Device Description

The ClearLLab 10C Reagent System is currently cleared on the Navios EX Flow cytometer under K183592. Beckman Coulter has developed the DxFLEX Flow Cytometer, a next generation flow cytometer that offers enhanced performance in terms of optics and electronics, as well as more convenient installation and operation. The indications for use of the ClearLLab 10C Reagent System will be expanded to include its use on the DxFLEX Flow Cytometer. Furthermore, the indications for use will be clearly stated on labeling. The intended use of the ClearLLab 10C Reagent System will not be modified.

ClearLLab 10C Reagent System components that are included with use on the DxFLEX Flow Cytometer:

DxFLEX Flow Cytometer [3 laser/10 color configuration] [New]
DxFLEX Daily OC Fluorospheres [New]
ClearLLab 10C Panels [B, T, M1 and M2] [Modification to Existing]
ClearLLab Compensation Kit [Modification to Existing]
ClearLLab Compensation Beads [Modification to Existing]
ClearLLab Control Cells, normal and abnormal [Modification to Existing]
Kaluza C data analysis software [Existing]
IOTest 3 Fixative Solution [Existing]
IOTest 3 Lysing Solution [Existing]

The ClearLLab 10C Reagent System is run on Beckman Coulter's DxFLEX Flow Cytometer (3 Laser/10 Color configuration). The DxFLEX Flow Cytometer includes the hardware and CytExpert for DxFLEX software. It requires off-line manual sample processing and use of the accompanying lysing reagent. As part of the ClearLLab 10C Reagent System, to allow proper utilization of this applications for the DxFLEX flow cytometers include ten fluorescent detection channels (FL1-FL10) and three laser configurations (blue, red and violet).

As with the workflow on the predicate system, LMD data analysis is performed manually using the Kaluza C Analysis Software. This Analysis Software package is supplied separately from the DxFLEX and must be installed on an independent computer workstation for off-line analysis of listmode files generated on the flow cytometer with the associated reagents and cytometer system software package, including Control Cell QC data and sample data analysis. The CvtExpert for DxFLEX software is NOT be recommended for analysis use with this application (Note that OC data DxFLEX Daily OC Fluorospheres and Compensation products will continue to be analyzed using the on-board instrument software).

Kaluza C Software is a software tool designed to work with *.fcs and *.lmd files generated from flow cytometers. The advantages of using the Kaluza C over the CytExpert for DxFLEX software are listed below:

Powerful processing speed allows fast analysis of listmode data, including real-time updating of gating and compensation
Plot displays are more versatile allowing linear, logarithmic and 'Logicle' (linear/log hybrid) axes as well as configurable scaling and zooming options
Range of compensation options
QC reporting includes Levey-Jennings plots and highlighted pass/fail criteria on results displays

Preset Kaluza C analysis templates for the ClearLLab 10C reagent system will be provided. The total WBC gate is defined in the histogram of SS vs. CD45-KO525-A by the inclusion of all CD45+ events with low, medium and high Side Scatter after the exclusion of the cells that were compromised and/or aggregated. A subsequent histogram defines specific leukocyte subset such as lymphocytes, monocytes, granulocytes. The low SS/bright CD45+ population identifies lymphocytes. Applicable markers are then displayed in subsequent histograms gated on lymphocytes. This process is repeated for mid SS/medium CD45+ populations to identify monocytes and for high SS/medium CD45+ to identify granulocytes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Flow Cytometry

Anatomical Site

Peripheral whole blood, bone marrow, and lymph node specimens.

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)

Laser Performance Characteristics:
- Testing Approach: Verify stability of the laser performance of the DxFLEX Flow Cytometer over time.
- Testing Results: Analysis of the data collected demonstrates that the DxFLEX Flow Cytometer laser performance is stable over time.
Instrument Carryover:
- Testing Approach: To verify carryover of the DxFLEX Daily QC Fluorospheres in specimens on the DxFLEX Flow Cytometer after running the required daily clean.
- Testing Results: Analysis of the data collected demonstrates that the DxFLEX Flow Cytometer meets the carryover performance requirements.
Instrument Linearity:
- Testing Approach: Verify fluorescence detection is linear using standard DxFLEX Flow Cytometer settings.
- Testing Results: Linearity of fluorescence measurements was demonstrated.
Carryover - Specimen and Reagent:
- Objective: To verify carryover of specimen and reagents on the DxFLEX Flow Cytometer meets performance specifications.
- Testing Results: Analysis of the data collected demonstrates that the DxFLEX Flow Cytometer meets carryover performance requirements.
Detection Capability:
- Objective: To verify that the ClearLLab 10C Reagent System on the DxFLEX Flow Cytometer meet the performance requirements for the ability to differentiate between abnormal and normal populations.
- Testing Results: Analysis of the data collected demonstrates that the ClearLLab 10C Reagent System on the DxFLEX Flow Cytometer meet the performance requirements for Detection Capability.
Precision - Control Material:
- Objective: Demonstrate system imprecision using control material as a surrogate for a stabilized sample.
- Testing Results: Analysis of the data collected demonstrates that the ClearLLab 10C Reagent System on the DxFLEX Flow Cytometer meets performance requirements for repeatability and reproducibility.
Precision - Multi-Site with Clinical Specimens:
- Objective: Demonstrate assay repeatability and reproducibility using both normal and clinical specimens.
- Testing Results: Analysis of the data collected demonstrates that the ClearLLab 10C Reagent System on the DxFLEX Flow Cytometer meets performance requirements for repeatability and reproducibility.
Precision - Operator and Instrument Variability:
- Objective: Demonstrate system imprecision performance of the ClearLLab 10C Reagent System on the DxFLEX Flow Cytometer using the same specimen prepared by three (3) operators, twice a day, on two (2) DxFLEX Flow Cytometers.
- Testing Results: The ClearLLab 10C Reagent System, when run on each specimen type by different operators on different DxFLEX Flow Cytometers, demonstrated acceptable precision performance and met acceptance criteria.
Clinical Accuracy:
- Objective: Demonstrate the performance equivalency between ClearLLab 10C Reagent System on DxFLEX cytometers (Test Method) and Navios EX flow cytometers (Predicate Method) by a multi-site evaluation of the qualitative immunophenotype agreement between the two systems using specimens from donors in the intended use population.
- Testing Results: Analysis of the data collected demonstrates that the ClearLLab 10C panels are able identify the abnormal population when compared to the predicate.
DxFLEX Daily QC Fluorospheres Analyte Value Assignment:
- Objective: Define DxFLEX Daily QC Fluorospheres Target Value ranges for use with the ClearLLab 10C Reagent System and define a process for ranges transfer from one lot of DxFLEX Daily QC Fluorospheres.
- Testing Results: Analysis of the data collected demonstrates that appropriate DxFLEX Daily QC Fluorospheres Target Value ranges are defined for use with the ClearLLab 10C Reagent System and that a process for range transfer from one lot of DxFLEX Daily QC Fluorospheres to another one is in place.

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.

K183592

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

Not Found

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

Not Found

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 22, 2023

Beckman Coulter, Inc Stephanie Harlacz Staff Regulatory Affairs Specialist 11800 SW 147 Ave Miami, Florida 33196

Re: K232600

Trade/Device Name: DxFLEX Flow Cytometer: ClearLLab 10C Panels Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: OYE, PWD Dated: August 25, 2023 Received: August 28, 2023

Dear Stephanie Harlacz:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Ying Mao -S

Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K232600 Device Name

DxFLEX Flow Cytometer; ClearLLab 10C Panels Indications for Use (Describe)

The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument

The ClearLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios, Navios EX and DxFLEX flow cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.

These reagents provide multiparameter, qualitative results for the surface antigens listed below:

· ClearLLab 10C B Cell Tube: Kappa, Lambda, CD10, CD5, CD200, CD34, CD38, CD20, CD19, CD45
· ClearLLab 10C T Cell Tube: TCRy6, CD4, CD2, CD56, CD5, CD34, CD3, CD8, CD7, CD45
· ClearLLab 10C M1 Cell Tube: CD16, CD7, CD10, CD13, CD64, CD34, CD14, HLA-DR, CD11b, CD45
· ClearLLab 10C M2 Cell Tube: CD15, CD123, CD117, CD13, CD33, CD34, CD38, HLA-DR, CD19, CD45

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.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

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3

510(k) Summary for ClearLLab 10C Reagents on DxFLEX Flow Cytometer

510(k) Owner / Submitter Information

Name: Beckman Coulter Inc. Address: 11800 SW 147th Ave., Miami, FL 33196 Phone #: (305) 563-0116 Contact Person: Stephanie Harlacz Email Address: smharlacz@beckman.com Date Submitted: 25 August 2023

Device Information

Trade Name: DxFLEX Flow Cytometer Common Name: DxFLEX Flow Cytometer Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: OYE Panel: Hematology

Trade Name: ClearLLab 10C (T), ClearLLab 10C (B), ClearLLab 10C (M1), ClearLLab (M2) Common Name: ClearLLab Reagents Classification Name: Flow Cytometric Test System for Hematopoietic Neoplasms (21 CFR 864.7010) Classification: Class II Product Code: PWD Panel: Hematology

4

Predicate Device Information

| Predicate Product | 510(k)
Number | Date
Cleared | Classification | 21 CFR | Product
Code |
|------------------------------|------------------|-----------------|----------------|----------|-----------------|
| Navios EX Flow Cytometer | K183592 | 03/21/2019 | Class II | 864.5220 | OYE |
| ClearLLab 10C Reagent System | K183592 | 03/21/2019 | Class II | 864.7010 | PWD |

Device Description

The ClearLLab 10C Reagent System is currently cleared on the Navios EX Flow cytometer under K183592. Beckman Coulter has developed the DxFLEX Flow Cytometer, a next generation flow cytometer that offers enhanced performance in terms of optics and electronics, as well as more convenient installation and operation. The indications for use of the ClearLLab 10C Reagent System will be expanded to include its use on the DxFLEX Flow Cytometer. Furthermore, the indications for use will be clearly stated on labeling. The intended use of the ClearLLab 10C Reagent System will not be modified.

ClearLLab 10C Reagent System components that are included with use on the DxFLEX Flow Cytometer:

DxFLEX Flow Cytometer [3 laser/10 color configuration] [New] ●
DxFLEX Daily OC Fluorospheres [New] ●
ClearLLab 10C Panels [B, T, M1 and M2] [Modification to Existing] ●
ClearLLab Compensation Kit [Modification to Existing]
ClearLLab Compensation Beads [Modification to Existing]
ClearLLab Control Cells, normal and abnormal [Modification to Existing]
Kaluza C data analysis software [Existing]
IOTest 3 Fixative Solution [Existing] ●
. IOTest 3 Lysing Solution [Existing]

5

The ClearLLab 10C Reagent System is run on Beckman Coulter's DxFLEX Flow Cytometer (3 Laser/10 Color configuration]. The DxFLEX Flow Cytometer includes the hardware and CytExpert for DxFLEX software. It requires off-line manual sample processing and use of the accompanying lysing reagent. As part of the ClearLLab 10C Reagent System, to allow proper utilization of this applications for the DxFLEX flow cytometers include ten fluorescent detection channels (FL1-FL10) and three laser configurations (blue, red and violet).

As with the workflow on the predicate system, LMD data analysis is performed manually using the Kaluza C Analysis Software. This Analysis Software package is supplied separately from the DxFLEX and must be installed on an independent computer workstation for off-line analysis of listmode files generated on the flow cytometer with the associated reagents and cytometer system software package, including Control Cell QC data and sample data analysis. The CvtExpert for DxFLEX software is NOT be recommended for analysis use with this application (Note that OC data DxFLEX Daily OC Fluorospheres and Compensation products will continue to be analyzed using the on-board instrument software).

Kaluza C Software is a software tool designed to work with *.fcs and *.lmd files generated from flow cytometers. The advantages of using the Kaluza C over the CytExpert for DxFLEX software are listed below:

Powerful processing speed allows fast analysis of listmode data, including real-time updating of gating and compensation
Plot displays are more versatile allowing linear, logarithmic and 'Logicle' (linear/log ● hybrid) axes as well as configurable scaling and zooming options
. Range of compensation options
. QC reporting includes Levey-Jennings plots and highlighted pass/fail criteria on results displays

Preset Kaluza C analysis templates for the ClearLLab 10C reagent system will be provided. The total WBC gate is defined in the histogram of SS vs. CD45-KO525-A by the inclusion of all CD45+ events with low, medium and high Side Scatter after the exclusion of the cells that were compromised and/or aggregated. A subsequent histogram defines specific leukocyte subset such as lymphocytes, monocytes, granulocytes. The low SS/bright CD45+ population identifies lymphocytes. Applicable markers are then displayed in subsequent histograms gated on lymphocytes. This process is repeated for mid SS/medium CD45+ populations to identify monocytes and for high SS/medium CD45+ to identify granulocytes.

Intended Use:

DxFLEX Flow Cytometer

The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to ten fluorescent detection channels using three lasers (488 mm, 638 nm. and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

6

ClearLLab 10C Panels

The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the DxFLEX flow cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. These reagents provide multiparameter, qualitative results for the surface antigens listed below:

ClearLLab 10C B Cell Tube: Kappa, Lambda, CD10, CD5, CD200, CD34, CD38, CD20, ● CD19, CD45
ClearLLab 10C T Cell Tube: TCRyS, CD4, CD2, CD56, CD5, CD34, CD3, CD8, CD7, ● CD45
ClearLLab 10C M1 Cell Tube: CD16, CD7, CD10, CD13, CD64, CD34, CD14, HLA-. DR, CD11b, CD45
ClearLLab 10C M2 Cell Tube: CD15, CD123, CD117, CD13, CD33, CD34, CD38, . HLA-DR, CD19, CD45

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Technological Characteristics Comparisons, Subject System to Predicate

| Characteristic | ClearLLab 10C Reagent System on
Navios EX flow cytometer (K183592) -
Predicate | ClearLLab 10C Reagent System
on DxFLEX flow cytometer |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA product code
for ClearLLab 10C
Panels | PWD | PWD |
| Intended Use | In vitro diagnostic device for immunophenotyping | In vitro diagnostic device for immunophenotyping |
| Indications for Use | Intended for in vitro diagnostic use as a panel for
qualitative identification of various cell
populations by immunophenotyping on the Navios
and Navios EX flow cytometers. These reagents
are used as an aid in the differential diagnosis of
hematologically abnormal patients having the
following hematopoietic neoplasms: chronic
leukemia, acute leukemia, non-Hodgkin
lymphoma, myeloma, myelodysplastic syndrome
(MDS), and/or myeloproliferative neoplasms
(MPN). The reagents can be used with peripheral
whole blood (collected in K2EDTA, ACD or
Heparin), bone marrow (collected in K2EDTA,
ACD or Heparin) and lymph node specimens for
immunophenotyping. The results should be
interpreted by a pathologist or equivalent in
conjunction with other clinical and laboratory
findings. | SAME (with the exception of cytometer)
Intended for in vitro diagnostic use as a panel for
qualitative identification of various cell populations by
immunophenotyping on the Navios, Navios EX and
DxFLEX flow cytometers. These reagents are used as an
aid in the differential diagnosis of hematologically
abnormal patients having the following hematopoietic
neoplasms: chronic leukemia, acute leukemia, non-
Hodgkin lymphoma, myeloma, myelodysplastic syndrome
(MDS), and/or myeloproliferative neoplasms (MPN). The
reagents can be used with peripheral whole blood
(collected in K2EDTA, ACD or Heparin), bone marrow
(collected in K2EDTA, ACD or Heparin) and lymph node
specimens for immunophenotyping. The results should be
interpreted by a pathologist or equivalent in conjunction
with other clinical and laboratory findings. |

.

8

| Characteristic | ClearLLab 10C Reagent System on
Navios EX flow cytometer (K183592) -
Predicate | | | | ClearLLab 10C Reagent System
on DxFLEX flow cytometer |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent Panels | B panel
KAPPA
LAMBDA
CD10
CD5
CD200
CD34
CD38
CD20
CD19
CD45 | T panel
TCRγδ
CD4
CD2
CD56
CD5
CD34
CD7
CD8
CD3
CD45 | M1 panel
CD16
CD7
CD10
CD13
CD64
CD34
CD14
HLA-DR
CD11b
CD45 | M2 panel
CD15
CD123
CD117
CD13
CD33
CD34
CD38
HLA-DR
CD19
CD45 | ALL MARKERS ARE THE SAME |
| Reagent Form | Dry unitized form (one test / panel) | | | | SAME |
| Storage Conditions | Room Temperature | | | | SAME |
| Set-up Reagents
Optical and Fluidics
Alignment | Flow-Check Pro Fluorospheres | | | | SIMILAR
DxFLEX Daily QC Fluorospheres
Same function. Designed to be used on 10 channels of the
DxFLEX flow cytometer |
| Set-up Reagents
Standardization | Flow-Set Pro Fluorospheres | | | | SIMILAR
DxFLEX Daily QC Fluorospheres
The standardization for the ClearLLab 10C Reagent
System on the DxFLEX Flow Cytometer is performed
with the same reagent and during the same step as the
optical alignment and fluidics verification. |

9

| Characteristic | ClearLLab 10C Reagent System on
Navios EX flow cytometer (K183592) -
Predicate | ClearLLab 10C Reagent System
on DxFLEX flow cytometer | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|------|
| | | DxFLEX Daily QC Fluorospheres have target values
assigned to monitor optical alignment and fluidics that are
also used as an aid in standardizing forward scatter, side
scatter, and fluorescence detectors on the DxFLEX Flow
Cytometer. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Lyse and Fixation | IOTest 3 Fixative Solution
IOTest 3 Lysing Solution | SAME | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sample Preparation | Wash and prepare samples manually | SAME | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sample Age and
Prepared Sample
Stability | Specimen Type K2EDTA ACD Heparin LN (Media) Whole Blood (WB)
Specimen Age 24 hours 48 hours 48 hours Prepared Sample Age 5 hours 5 hours 5 hours Bone Marrow (BM)
Specimen Age 24 hours 48 hours 48 hours Prepared Sample Age 5 hours 5 hours 5 hours Lymph Node (LN)
Prepared Sample Age 5 hours | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | SAME |
| | Color Compensation | ClearLLab Compensation Kit with ClearLLab
Compensation Beads | SAME, except with labeling changes to include DxFLEX
Flow Cytometer only | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Control cells | ClearLLab Control cells (normal and abnormal) | SAME, except with labeling changes to include DxFLEX
Flow Cytometer and assay ranges specific for the
DxFLEX Flow Cytometer | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

10

| Attribute | Navios EX Flow Cytometer
(K183592) | DxFLEX Flow Cytometer |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA product
code for Flow
Cytometer | OYE | OYE |
| Intended Use | The Navios EX Flow Cytometer is intended for use as
an in vitro diagnostic device for immunophenotyping
using up to ten fluorescent detection channels using
three lasers (488 nm, 638 nm, and 405 nm) and two
light scatter detection channels. It is intended for use
with in vitro diagnostic (IVD) assays and software that
are indicated for use with the instrument. | The DxFLEX Flow Cytometer is intended for use as an in
vitro diagnostic device for immunophenotyping using up
to ten fluorescent detection channels using three lasers
(488 nm, 638 nm, and 405 nm) and two light scatter
detection channels. It is intended for use with in vitro
diagnostic (IVD) assays and software that are indicated
for use with the instrument. |
| Safety Features | Interlocks and mitigation of hazards via software and
hardware controls | SAME |
| Software
Architecture | The acquisition software enables the user to acquire
data from the instrument and to analyze, display, print
and export acquired data.
The embedded software resides in the instrument. It
controls the instrument functionality including the
multi-carousel loader (MCL) for sample introduction.
The embedded software controls the instruments' lasers,
acquisition system and fluidics. The instrument fluidics
aspirates the sample, and performs instrument
maintenance functions such as startup/shutdown. The
embedded software also captures and provides the data
to the workstation for processing. | SAME |
| Pre-Analytic Features | | |
| Attribute | Navios EX Flow Cytometer
(K183592) | DxFLEX Flow Cytometer |
| System
Configuration | Workstation
• PC based workstation running Microsoft Windows 7 and Windows 10 application specific software | SAME, except the workstation only runs Windows 10 Enterprise LTSC 2019 |
| Sample
Preparation | Off-board sample preparation following instructions provided with cleared antibody reagent | SAME |
| Sample
Presentation | Sample prepared in dry reagent tube presented in the same tube | SAME |
| Resuspension of
prepared sample
prior to
introduction to
system | Prepared sample is vortex mixed | SAME |
| Sample
Introduction | Tube sampler
• Automated presentation with Multi-tube Carousel Loader (MCL) from 32 test tube capacity carousel
• Manual presentation into a tube location on a MCL | SAME |
| Sample
Identification | Bar-code reading of carousel position and labeled sample tube. User may also identify samples based on carousel location with a worklist. | SAME |
| Aspiration
Pathway | Same aspiration pathway used for automated and manual presentation | Using peristaltic pump for automatic presentation |
| Sample
Aspiration
Probe | Adjustable (by Beckman Coulter field service personnel) | Adjustable (both Beckman Coulter field service personnel and user) |
| Analytical Features | | |
| Lasers / Driver
Boards | Blue (488 nm)
• Diode Pumped Solid State (DPSS), 55mW
• 488 nm laser driver board | Blue (488 nm)
• Diode Pumped Solid State (DPSS), 50mW
• 488 nm laser driver board |
| Attribute | Navios EX Flow Cytometer
(K183592) | DxFLEX Flow Cytometer |
| | Red (638 nm) Diode Pumped Solid State (DPSS), 50 mW 638 nm laser driver board Violet (405 nm) Diode Pumped Solid State (DPSS), 80 mW 405 nm laser driver board | Red (638 nm) Diode Pumped Solid State (DPSS), 50 mW 638 nm laser driver board Violet (405 nm) Diode Pumped Solid State (DPSS), 85 mW 405 nm laser driver board |
| Forward Angle
Light Scatter | Forward scatter mask Single lens collimates the light Band-pass filter passes only 488nm light Diode detector converts light into electrical signals | Forward scatter mask Use ellipsoidal mirror to focus the light Band-pass filter passes only 488nm light Diode detector converts light into electrical signals |
| Optics | Spherical and cylindrical lenses coupled to the flow cell | Aspherical and cylindrical lenses coupled to the flow cell |
| Flow Cell | Channel Size: 140 x 460 microns Sheath Flow Pressure: 4 psi Thin wall to allow for gel coupling distance Optics module temperature management hardware: one thermoelectric devices at the top and bottom of the optics module box | Channel Size: 180 x 430 microns Sheath Flow Pressure: 18.8 kPa Optics module temperature management hardware: two thermoelectric devices at the top and bottom of the optics module box |
| Fluorescence
collection | Collection lens and light path: Spherical mirror and aspheric Schmidt lens No gel coupling, NA=1.2. Light passes through optical fiber to PMT area Light leaves the fiber and is collimated | Collection lens and light path Spherical mirror and aspheric Schmidt lens Gel coupled to flow cell Light passes through optical fiber to WDM area Light leaves the fiber and is collimated Collimated light is separated by filters into desired bands |
| Attribute | Navios EX Flow Cytometer
(K183592) | DxFLEX Flow Cytometer |
| | Collimated light is separated by filters into desired bands
PMTs detect light and convert to electrical signals | APDs (Avalanche Photodiodes) detect light and convert to electrical signals |
| Maximum
Parameter
Detectors | Twelve (Forward Scatter, Side Scatter and 10 fluorescence channels) | Twelve (Forward Scatter, Side Scatter and 10 fluorescence channels) |
| Electronics | 40 MHz sampling | 25 MHz sampling
ClearLLab 10C application will require the first 10 APDs. |
| Detectors /
Colors | Standard 5 PMTs (FL1 – FL5) off of 488 nm laser (blue)
Standard 3 PMTs (FL6 – FL8) off of 638 nm laser (red)
Standard 2 PMTs (FL9 – FL10) off of 405 nm laser (violet) | Standard 5 APDs (FITC – PC7 off of 488 nm laser (blue)
Standard 3 APDs (APC – APC-A750) off of 638 nm laser (red)
Standard 2 APDs (PB450 – KO525) off of 405 nm laser (violet) |
| Optical Filters | Optical Filters: (SP = Short Pass, BP = Band Pass, LP = Long Pass)
• FITC 550 SP - 525 BP
• PE 595 SP- 575/30 BP
• ECD 655 SP - 614/20 BP
• PC5.5 730 SP - 695/30 BP
• PC7 755 LP
• APC 710 SP- 660/20 BP
• APC-A700 750 SP – 725/20 BP
• APC-A750 755 LP
• PB 480 SP – 450/50 BP
• KRO 550/40 BP | Optical Filters (all band pass):
• FITC 525/40
• PE 585/42
• ECD 610/20
• PC5.5 690/50
• PC7 780/60
• APC-A750 780/60
• APC 660/10
• APC-700 712/25
• PB450 450/45
• KO525 525/40 |
| Color
Separation | Collimated beam is separated into desired components with dichroic filters. | Use filter to separate into desired components. |
| Attribute | Navios EX Flow Cytometer
(K183592) | DxFLEX Flow Cytometer |
| On-board
acquisition
software | System Software available | SAME |
| Analysis
Software | Kaluza C data analysis software to be used with the
ClearLLab 10C application and to be used off-line. | SAME, except provided analysis protocols will be
specific for ClearLLab Reagents on DxFLEX Flow
Cytometer |
| | Navios EX on-board and off-line analysis software is
not recommended for use of control cell and sample
data analysis. | CytExpert for DxFLEX software will not be
recommended for use of control cell and sample data
analysis. |
| Post-Analytical Features | | |
| Data Reporting | Report, Plots and Statistics printouts | SAME |
| Cleaning Cycle
Between
Samples | Executed with Sheath Fluid ensuring carryover
specification is met | SAME |
| Quality Control
Techniques | Daily Instrument Checks Supplied Controls for ClearLLab 10C application | SAME |
| Cleanse Cycle | Cleaning cycle performed with FlowClean cleaning
reagent as part of the daily shutdown process, before
and after running samples with vital dyes that stain the
tubing, and as part of troubleshooting. | SAME, except additional cleaning cycle required after
running DxFLEX Daily QC Fluorospheres |
| Reagents used
for
compensation
and sample
preparation | ClearLLab Compensation Kit and Compensation Beads
will be used with the ClearLLab 10C application. | SAME, except with labeling changes to include DxFLEX
Flow Cytometer only |
| Attribute | Navios EX Flow Cytometer
(K183592) | DxFLEX Flow Cytometer |
| Assay Controls
and Calibrators | Flow-Check Pro Fluorospheres
Flow-Set Pro Fluorospheres | SIMILAR
DxFLEX Daily QC Fluorospheres have target values
assigned to monitor optical alignment and fluidics and to
aid in standardization. |
| Process
Controls | ClearLLab Control Cells (Normal and Abnormal) | SAME except with labeling changes to include DxFLEX
Flow Cytometer and assay ranges specific for the
DxFLEX Flow Cytometer |
| Instrument Software | | |
| Processor | PowerPC | SAME |
| Programming
Language | C++ | C# C++ |
| RTOS | VxWorks | N/A |
| Workstation
Interface | Ethernet | USB Ethernet |
| Data
Acquisition | Digital Pulse Processing | SAME |
| General | Software functionality to allow:
Patient data management – storage, review, reporting Control data management – storage, review, reporting System configuration management System service test and adjustment procedures. | SAME |
| Attribute | Navios EX Flow Cytometer
(K183592) | DxFLEX Flow Cytometer |
| Data Processing | Region/gates evaluation Statistics generation Export of results to MS Excel/PDFfile | Region/gates evaluation Statistics generation Export of results to CSV/PDF file. |
| Standardization | Automatic voltage/gain adjustments | Automatic gain calibration using target value |
| User interface | Plots and reports | SAME |
| Control
Software | The acquisition software enables the user to acquire data from the Navios EX Flow Cytometer and to analyze, display, print and export acquired listmode data. The embedded software resides in the Navios EX instrument. It controls the instrument functionality including the multi-carousel loader (MCL) for sample introduction. The embedded software controls the instruments' lasers, acquisition system and fluidics. The instrument fluidics aspirates the sample, and performs instrument maintenance functions such as startup/shutdown. The embedded software also captures and provides the data to the workstation for processing. Communication protocol | CytExpert for DxFLEX software enables the user to acquire data from the DxFLEX flow cytometer instrument and to analyze, display, print and export acquired fcs file. CytExpert for DxFLEX controls the instrument functionality including the multi-carousel loader (MCL) for sample introduction. CytExpert for DxFLEX controls the instruments' lasers, acquisition system and fluidics. The instrument fluidics aspirates the sample, and performs instrument maintenance functions such as startup/shutdown. CytExpert for DxFLEX also captures and provides the data to the workstation for processing. Communication protocol |
| Data Processing | Region and Gate processing Statistics Generation Export to Excel Incoming data stream formatted into per-parameter vectors for improved performance of lin/log data transformations and compensation calculations | Region and Gate processing Statistics Generation Export to CSV Incoming data stream formatted into per-parameter vectors for improved performance of lin/log data transformations and compensation calculations |
| Attribute | Navios EX Flow Cytometer
(K183592) | DxFLEX Flow Cytometer |
| User Account
Control | Enhanced security and user permissions functionality Multiple role assignments User account information stored in password protected database. Additional password timeout and auto-lockout of user on repeated password failure | Enhanced security and user permissions functionality Multiple role assignments User account information encrypted and stored in password protected database. Additional password timeout and auto-lockout of user on repeated password failure. Password complexity policy. |
| Report
generator | Panel reports & QC | SAME |

Technological Characteristics Comparisons, Subject Instrument to Predicate

11

12

13

14

510(k) Submission for ClearLLab 10C Reagent System on the DxFLEX Flow Cytometer 510(k) Summary

15

16

17

Summary of Instrument Characterization and Analytical Performance Testing

Study	Testing Approach	FDA Guidance Documents	Standards/ References	Testing Results
Laser Performance
Characteristics	Verify stability of the laser
performance of the DxFLEX
Flow Cytometer over time.	None	None	Analysis of the data collected demonstrates
that the DxFLEX Flow Cytometer laser
performance is stable over time.
Instrument Carryover	To verify carryover of the
DxFLEX Daily QC
Fluorospheres in specimens
on the DxFLEX Flow
Cytometer after running the
required daily clean	Special Controls Guidance
Document: Premarket
Notifications for Automated
Differential Cell Counters
for Immature or Abnormal
Blood Cells - Carryover
(Section 12)	CLSI H26-A2; FDA Standards
Recognition #7-210	Analysis of the data collected demonstrates
that the DxFLEX Flow Cytometer meets the
carryover performance requirements.
Instrument Linearity	Verify fluorescence detection
is linear using standard
DxFLEX Flow Cytometer
settings.	None	None	Linearity of fluorescence measurements was
demonstrated.
Study	Objective	FDA Guidance Documents	Standards/ References	Testing Results
Carryover - Specimen and
Reagent	To verify carryover of
specimen and reagents on the
DxFLEX Flow Cytometer
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 DxFLEX Flow Cytometer meets
carryover performance requirements.
Detection Capability	To verify that the ClearLLab
10C Reagent System on the
DxFLEX Flow Cytometer
meet the performance
requirements for the ability to
differentiate between
abnormal and normal
populations.	None	Wood B et al. Validation of Cell-
Based Fluorescence Assays:
Practice Guidelines from the ICSH
and ICCS - Part V - Assay
performance Criteria. Cytometry
Part B (Clinical Cytometry), pp.
315-323	Analysis of the data collected demonstrates
that the ClearLLab 10C Reagent System on
the DxFLEX Flow Cytometer meet the
performance requirements for Detection
Capability.
Precision - Control
Material	Demonstrate system
imprecision using control
material as a surrogate for a
stabilized sample	Special Controls Guidance
Document: Premarket
Notifications for
Automated Differential
Cell Counters for Immature
or Abnormal Blood Cells -
Precision (Section 9)	CLSI EP05-A3. Evaluation of
Precision of Quantitative
Measurement Procedures:
Approved Guideline – Third
Edition. FDA Standards
Recognition #7-251	Analysis of the data collected demonstrates
that the ClearLLab 10C Reagent System on
the DxFLEX Flow Cytometer meets
performance requirements for repeatability
and reproducibility.
Precision - Multi-Site with
Clinical Specimens	Demonstrate assay
repeatability and
reproducibility using both
normal and clinical
specimens.	Special Controls Guidance
Document: Premarket
Notifications for
Automated Differential
Cell Counters for Immature
or Abnormal Blood Cells -
Precision (Section 9)	CLSI EP05-A3, Evaluation of
Precision of Quantitative
Measurement Procedures;
Approved Guideline – Third
Edition. FDA Standards
Recognition #7-251
User Protocol for Evaluation of
Qualitative Test Performance;
Approved Guideline - Second	Analysis of the data collected demonstrates
that the ClearLLab 10C Reagent System on
the DxFLEX Flow Cytometer meets
performance requirements for repeatability
and reproducibility.
Study	Objective	FDA Guidance Documents	Standards/ References	Testing Results
Precision - Operator and
Instrument Variability	Demonstrate system
imprecision performance of
the ClearLLab 10C Reagent
System on the DxFLEX Flow
Cytometer using the same
specimen prepared by three
(3) operators, twice a day, on
two (2) DxFLEX Flow
Cytometers.	Special Controls Guidance
Document: Premarket
Notifications for
Automated Differential
Cell Counters for Immature
or Abnormal Blood Cells -
Precision (Section 9)	CLSI EP05-A3, Evaluation of
Precision of Quantitative
Measurement Procedures;
Approved Guideline – Third
Edition. FDA Standards
Recognition #7-251
User Protocol for Evaluation of
Qualitative Test Performance;
Approved Guideline - Second
Edition; CLSI EP12-A2; FDA
Standards Recognition #7-152	The ClearLLab 10C Reagent System, when
run on each specimen type by different
operators on different DxFLEX Flow
Cytometers, demonstrated acceptable
precision performance and met acceptance
criteria.
Clinical Accuracy	Demonstrate the performance
equivalency between
ClearLLab 10C Reagent
System on DxFLEX
cytometers (Test Method) and
Navios EX flow cytometers
(Predicate Method) by a
multi-site evaluation of the
qualitative immunophenotype
agreement between the two
systems using specimens from
donors in the intended use
population.	None	CLSI H43-A2: Clinical Flow
Cytometric Analysis of Neoplastic
Hematolymphoid Cells - Second
Edition; FDA Standards
Recognition #7-150
User Protocol for Evaluation of
Qualitative Test Performance;
Approved Guideline - Second
Edition; CLSI EP12-Ed3; FDA
Standards Recognition #7-315
CLSI EP09-A3: Measurement
Procedure Comparison and Bias
Estimation Using Patient Samples;
Approved Guideline-3rd Edition;
FDA Standards Recognition #7-296	Analysis of the data collected demonstrates
that the ClearLLab 10C panels are able
identify the abnormal population when
compared to the predicate.
Study	Objective	FDA Guidance Documents	Standards/ References	Testing Results
DxFLEX Daily QC
Fluorospheres Analyte
Value Assignment	Define DxFLEX Daily QC
Fluorospheres Target Value
ranges for use with the
ClearLLab 10C Reagent
System and define a process
for ranges transfer from one
lot of DxFLEX Daily QC
Fluorospheres.	None	None	Analysis of the data collected demonstrates
that appropriate DxFLEX Daily QC
Fluorospheres Target Value ranges are
defined for use with the ClearLLab 10C
Reagent System and that a process for range
transfer from one lot of DxFLEX Daily QC
Fluorospheres to another one is in place.

18

Summary of System Performance Testing:

19

20

Summary of Accessory Reagents Performance Testing:

21

Substantial Equivalence Conclusion to Demonstrate Safety, Effectiveness & Equivalent Performance to Predicate:

The ClearLLab 10C Reagents on the DxFLEX Flow Cytometer, that is the subject of this submission, in concert with the conclusions drawn from the performance testing discussed above demonstrate that when compared to the predicate device is as effective, and meets the performance acceptance criteria.

In summary, the ClearLLab 10C Reagents on the DxFLEX Flow Cytometer as described in this submission is substantially equivalent in terms of safety and effectiveness to its predicate devices.

The ClearLLab 10C Reagents on the DxFLEX Flow Cytometer is substantially equivalent to the ClearLLab 10C Reagents on the Navios EX Flow Cytometer.

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.

Intended Use / Indications for Use

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

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

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

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

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

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

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.

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).

§ 864.5220 Automated differential cell counter.

Dear Stephanie Harlacz:

Ying Mao -S

Indications for Use

K232600 Device Name

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary for ClearLLab 10C Reagents on DxFLEX Flow Cytometer

510(k) Owner / Submitter Information

Device Information

Trade Name: ClearLLab 10C (T), ClearLLab 10C (B), ClearLLab 10C (M1), ClearLLab (M2) Common Name: ClearLLab Reagents Classification Name: Flow Cytometric Test System for Hematopoietic Neoplasms (21 CFR 864.7010) Classification: Class II Product Code: PWD Panel: Hematology

Predicate Device Information

Device Description

Intended Use:

DxFLEX Flow Cytometer

ClearLLab 10C Panels

Technological Characteristics Comparisons, Subject System to Predicate

Technological Characteristics Comparisons, Subject Instrument to Predicate

Summary of Instrument Characterization and Analytical Performance Testing

Summary of System Performance Testing:

Summary of Accessory Reagents Performance Testing:

Substantial Equivalence Conclusion to Demonstrate Safety, Effectiveness & Equivalent Performance to Predicate:

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!