The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios EX 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, non-Hodgkin lymphoma, myeloma, myeloma, 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.
Device Story
ClearLLab 10C Panels are in vitro diagnostic reagents for multiparameter immunophenotyping of hematopoietic neoplasms. System includes four reagent tubes (B, T, M1, M2), compensation kit, control cells, and Kaluza C analysis software. Operates on Navios/Navios EX flow cytometers (3-laser/10-color). Workflow involves manual off-line sample preparation (lysing/fixation), followed by flow cytometric analysis. Instrument measures fluorescence and light scatter; data exported as listmode (.lmd) files. Kaluza C software, installed on an independent workstation, performs manual analysis using preset templates. Pathologists interpret qualitative results to aid differential diagnosis. Benefits include standardized identification of abnormal cell populations in blood, bone marrow, and lymph node samples.
Clinical Evidence
Bench testing only. Studies included laser performance stability, instrument carryover, linearity, cell recovery equivalence between Navios and Navios EX, antibody specificity, titration, non-specific binding assessment, lot-to-lot reproducibility, reagent stability, and clinical accuracy (identifying abnormal vs. normal phenotypes). All testing met acceptance criteria.
Technological Characteristics
Flow cytometric test system using 3-laser (488nm, 638nm, 405nm) and 10-color fluorescence detection. Reagents are dry unitized panels. System includes Kaluza C software for off-line analysis. Connectivity via listmode file transfer. Quality control via Flow-Set Pro and Flow-Check Pro fluorospheres. Complies with CLSI standards (e.g., EP09-A3, EP5-A3, EP25-A).
Indications for Use
Indicated for qualitative identification of cell populations via multiparameter immunophenotyping in patients suspected of having hematopoietic neoplasms (chronic leukemia, non-Hodgkin lymphoma, myeloma, MDS, MPN). Used with peripheral whole blood, bone marrow, and lymph node specimens.
Regulatory Classification
Identification
A flow cytometric test for hematopoietic neoplasms is a device that consists of reagents for immunophenotyping of human cells in relation to the level of expression, antigen density, and distribution of specific cellular markers. These reagents are used as an aid in the differential diagnosis or monitoring of hematologically abnormal patients having or suspected of having hematopoietic neoplasms. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must indicate the clinical hematopoietic neoplasms for which the assay was designed and validated, for example, chronic leukemia or lymphoma.
(ii) A detailed device description including the following:
(A) A detailed description of all test components, all required reagents, and all instrumentation and equipment, including illustrations or photographs of nonstandard equipment or methods.
(B) Detailed documentation of the device software including, but not limited to, standalone software applications and hardware-based devices that incorporate software.
(C) A detailed description of methodology and assay procedure.
(D) A description of appropriate internal and external quality control materials that are recommended or provided. The description must identify those control elements that are incorporated into the testing procedure, if applicable.
(E) Detailed specifications for sample collection, processing, and storage.
(F) Detailed specification of the criteria for test results interpretation and reporting including pre-established templates.
(G) If applicable, based on the output of the results, a description of the specific number of events to collect, result outputs, and analytical sensitivity of the assay that will be reported.
(iii) Information that demonstrates the performance characteristics of the test, including:
(A) Device performance data from either a method comparison study comparing the specific lymphocyte cell markers to a predicate device or data collected through a clinical study demonstrating clinical validity using well-characterized clinical specimens. Samples must be representative of the intended use population of the device including hematologic neoplasms and the specific sample types for which the test is indicated for use.
(B) If applicable, device performance data from a clinical study demonstrating clinical validity for parameters not established in a predicate device of this generic type using well-characterized prospectively obtained clinical specimens including all hematologic neoplasms and the specific sample types for which the device is indicated for use.
(C) Device precision data using clinical samples to evaluate the within-lot, between-lot, within-run, between run, site-to-site and total variation using a minimum of three sites, of which at least two sites must be external sites. Results shall be reported as the standard deviation and percentage coefficient of variation for each level tested.
(D) Reproducibility data generated using a minimum of three lots of reagents to evaluate mean fluorescence intensity and variability of the recovery of the different markers and/or cell populations.
(E) Data from specimen and reagent carryover testing performed using well-established methods (
*e.g.,* CLSI H26-A2).(F) Specimen and prepared sample stability data established for each specimen matrix in the anticoagulant combinations and storage/use conditions that will be indicated.
(G) A study testing anticoagulant equivalency in all claimed specimen type/anticoagulant combinations using clinical specimens that are representative of the intended use population of the device.
(H) Analytic sensitivity data using a dilution panel created from clinical samples.
(I) Analytical specificity data, including interference and cross-contamination.
(J) Device stability data, including real-time stability of reagents under various storage times and temperatures.
(K) For devices that include polyclonal antibodies, Fluorescence Minus One (FMO) studies to evaluate non-specific binding for all polyclonal antibodies. Each FMO tube is compared to reagent reference to demonstrate that no additional population appears when one marker is absent. Pre-specified acceptance criteria must be provided and followed.
(L) For devices indicated for use as a semi-quantitative test, linearity data using a dilution panel created from clinical samples.
(M) For devices indicated for use as a semi-quantitative test, clinically relevant analytical sensitivity data, including limit of blank, limit of detection, and limit of quantification.
(iv) Identification of risk mitigation elements used by the device, including a detailed description of all additional procedures, methods, and practices incorporated into the instructions for use that mitigate risks associated with testing the device.
(2) The 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use statement in the 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include a statement that the results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. The intended use statement must also include information on what the device detects and measures, whether the device is qualitative, semi-quantitative, and/or quantitative, the clinical indications for which the device is to be used, and the specific population(s) for which the device is intended.
(ii) A detailed description of the performance studies conducted to comply with paragraph (b)(1)(iii) of this section and a summary of the results.
(3) As part of the risk management activities performed under 21 CFR 820.10(c) design and development, product labeling and instruction manuals must include clear examples of all expected phenotypic patterns and gating strategies using well-defined clinical samples representative of both abnormal and normal cellular populations. These samples must be selected based upon the indications described in paragraph (b)(1)(i) of this section.
DEN160047 — ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M · Beckman Coulter · Jun 29, 2017
K232600 — DxFLEX Flow Cytometer; ClearLLab 10C Panels · Beckman Coulter, Inc. · Nov 22, 2023
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2019
Beckman Coulter Anthony Dennis Sr. Manager 11800 SW 147th Ave. Miami, Florida 33196-2500
Re: K183592
Trade/Device Name: ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer Regulation Number: 21 CFR 864.7010 Regulation Name: Flow cytometric test system for hematopoietic neoplasms Regulatory Class: Class II Product Code: PWD, OYE Dated: December 20, 2018 Received: December 21, 2018
Dear Anthony Dennis:
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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Douglas A. Jeffery -S
Doug Jeffery Acting Deputy Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K183592
Device Name ClearLLab 10C Panels (B, T, M1, M2)
#### Indications for Use (Describe)
The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios EX 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, non-Hodgkin lymphoma, myeloma, myeloma, 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: TCRy8, 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, CD34, CD38, HLA-DR, CD19, CD45
Type of Use (Select one or both, as applicable)
| <span style="font-size:10pt"><span style="font-family:Wingdings">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt"><span style="font-family:Wingdings">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
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# Indications for Use
510(k) Number (if known) K183592
Device Name Navios Flow Cytometer
Indications for Use (Describe)
The Navios 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, 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.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span>☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
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# Indications for Use
510(k) Number (if known) K183592
Device Name Navios EX Flow Cytometer
Indications for Use (Describe)
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, and 405 mm) 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.
| 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.
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."
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| Section 5 | 510(k) Summary |
|-----------|----------------|
|-----------|----------------|
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# 510(k) Summary for ClearLLab 10C Reagents
#### 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: Anthony Dennis Email Address: adennis@beckman.com Date Submitted: 12 December 2018
#### 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
#### Trade Name: Navios Flow Cvtometer
Common Name: Navios Flow Cytometer Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: OYE Panel: Hematology
#### Trade Name: Navios EX Flow Cytometer
Common Name: Navios EX Flow Cytometer Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: OYE Panel: Hematology
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## Predicate Device Information
| Predicate Product | 510(k)<br>Number | Date<br>Cleared | Classification | 21 CFR | Product<br>Code |
|--------------------------|------------------|-----------------|----------------|----------|-----------------|
| ClearLLab Reagents | DEN160047 | 06/29/2017 | Class II | 864.7010 | PWD |
| Navios Flow Cytometer | K130373 | 9/18/2013 | Class II | 864.5220 | OYE |
| Navios EX Flow Cytometer | K162897 | 6/23/2017 | Class II | 864.5220 | OYE |
## Device Description
The new ClearLLab 10C reagent system is comprised of various components and is described below. Figures 2 and 3 illustrate the anticipated workflow from instrument setup through data analysis with a breakout of the standardization and Quality Control sequence for the new reagent system. As the figures show, the process is in-line with standard flow cytometry protocol.
- Four ClearLLab 10C Panels [B, T, M1 and M2] A
- > Navios and Navios EX flow cytometers [3 laser/10 color configurations]
- ClearLLab Compensation Kit A
- ClearLLab Compensation Beads A
- ClearLLab Control Cells, normal and abnormal A
- A Kaluza C data analysis software
- Flow-Check Pro Fluorospheres A
- Flow-Set Pro Fluorospheres A
- > IOTest 3 Fixative Solution
- > IOTest 3 Lysing Solution
The ClearLLab 10C reagent system is run on Beckman Coulter's Navios or Navios EX flow cytometer (3 Laser/10 Color configurations). 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 application, the indications for the Navios and Navios EX flow cvtometers include all ten fluorescent detection channels and three laser configurations (blue, red and violet).
LMD data analysis is performed manually using the Kaluza C Analysis Software. This Analysis Software package is supplied separately from the Navios EX system softwares 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 OC data and sample data analysis. The Navios and Navios EX analysis software are NOT be recommended for use with this application (Note that QC data from Flow-Set Pro, Flow-Check Pro, 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 *.Imd files generated from flow cytometers.
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Preset Kaluza C analysis templates for the ClearLLab 10c reagent system are provided.
# Intended Use:
# ClearLLab 10C Reagents
The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter 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, or suspected of 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, 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
# Navios Flow Cytometer
The Navios 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.
## Navios EX Flow Cytometer
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 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.
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# Technological Characteristics Comparisons to Predicate
| | Table 1: Similarities of Features/Characteristics between the Predicate and Subject Device |
|--|--------------------------------------------------------------------------------------------|
|--|--------------------------------------------------------------------------------------------|
| Characteristic | New ClearLLab 10C Reagent System<br>Subject Device | Predicate ClearLLab Reagents (5-color)<br>(De Novo DEN160047) | | | | | | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------|-------------------------------------------------------------------------------------------|----------|----------|----------|---------|
| FDA product code | PWD<br>(based on De Novo submission DEN160047) | PWD | | | | | | | |
| Intended Use | In vitro diagnostic device for immunophenotyping | In vitro diagnostic device for immunophenotyping | | | | | | | |
| Indications for Use | SAME (with the exception of cytometer and clarifying<br>language)<br>Intended for in vitro diagnostic use as a panel for qualitative<br>identification of cell populations by multiparameter<br>immunophenotyping on the Navios and Navios EX flow<br>cytometers. These reagents are used as an aid in the<br>differential diagnosis of hematologically abnormal patients<br>having the following hematopoietic neoplasms: chronic<br>leukemia, acute leukemia, non-Hodgkin lymphoma,<br>myeloma, myelodysplastic syndrome (MDS), and/or<br>myeloproliferative neoplasms (MPN). The reagents can be<br>used with peripheral whole blood (collected in K2EDTA,<br>ACD or Heparin), bone marrow (collected in K2EDTA, ACD<br>or Heparin) and lymph node specimens for<br>immunophenotyping. Interpretation of the results should be<br>confirmed by a pathologist or equivalent in conjunction with<br>other clinical and laboratory findings. | Intended for in vitro diagnostic use as a panel for qualitative<br>identification of cell populations by immunophenotyping on an<br>FC 500 flow cytometer. These reagents are used as an aid in<br>the differential diagnosis of hematologically abnormal patients<br>having the following hematopoietic neoplasms: chronic<br>leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma,<br>myelodysplastic syndrome (MDS), and/or myeloproliferative<br>neoplasms (MPN). The reagents can be used with peripheral<br>whole blood (collected in K2EDTA, ACD or Heparin), bone<br>marrow (collected in K2EDTA, ACD or Heparin) and lymph<br>node specimens for immunophenotyping. The results should<br>be interpreted by a pathologist or equivalent in conjunction<br>with other clinical and laboratory findings. | | | | | | | |
| Reagent Panels | <b>BOLDED MARKERS ARE THE SAME</b> | | | | | | | | |
| | B panel | T panel | M1 panel | M2 panel | B1 panel | B2 panel | T1 panel | T2 panel | M panel |
| | KAPPA | TCRγδ | CD16 | CD15 | CD2 | CD8 | KAPPA | CD20 | CD7 |
| | LAMBDA | CD4 | CD7 | CD123 | CD56 | CD4 | LAMBDA | CD10 | CD13 |
| | CD10 | CD2 | CD10 | CD117 | CD7 | | CD19 | CD19 | CD34 |
| Characteristic | New ClearLLab 10C Reagent System<br>Subject Device | | | | Predicate ClearLLab Reagents (5-color)<br>(De Novo DEN160047) | | | | |
| | CD5 | CD56 | CD13 | CD13 | CD5 | CD3 | CD5 | CD38 | CD33 |
| | CD200 | CD5 | CD64 | CD33 | CD45 | CD45 | CD45 | CD45 | CD4 |
| | CD34 | CD34 | CD34 | CD34 | | | | | |
| | CD38 | CD7 | CD14 | CD38 | | | | | |
| | CD20 | CD8 | HLA-DR | HLA-DR | | | | | |
| | CD19 | CD3 | CD11b | CD19 | | | | | |
| | CD45 | CD45 | CD45 | CD45 | | | | | |
| Reagent Form | Dry unitized form (one test / panel) | | | | Liquid form | | | | |
| Storage Conditions | 18-30°C | | | | 2-8°C | | | | |
| Set-up Reagents<br>Standardization | SIMILAR<br>Flow-Set Pro Fluorospheres:<br>Same function, but expanded to allow use on all 10 channels<br>of the Navios and Navios EX | | | | Flow-Set Pro Fluorospheres | | | | |
| Optical alignment and<br>fluidics | SIMILAR<br>Flow-Check Pro Fluorospheres:<br>Same function, but expanded to allow use on all 10 channels<br>of the Navios and Navios EX | | | | Flow-Check Pro Fluorospheres | | | | |
| Lyse and Fixation | SIMILAR, EXISTING<br>IOTest 3 Fixative Solution<br>IOTest 3 Lysing Solution | | | | IOTest 3 Fixative Solution<br>VersaLyse Lysing Solution | | | | |
| Sample Preparation | SIMILAR<br>Wash and prepare samples manually | | | | Wash and prepare samples manually | | | | |
| Reagents for Color | NEW | | | | | | | | |
| Compensation<br>ClearLLab Compensation | ClearLLab Compensation Kit with ClearLLab Compensation | | | | | | | | |
| Kit and ClearLLab<br>Compensation Beads | Beads: the Compensation Kit includes dry reagents used to<br>set color compensation settings. The kit contains 10 tubes of<br>a single color reagent per use, each containing a single<br>antibody conjugated to a specific fluorochrome. The<br>Compensation Beads are positive and negative microspheres | | | | CD45-FITC, CD45-PE and CD45-ECD from existing<br>QuickComp 4 plus CD45-PC5.5 and CD45-PC7 | | | | |
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| Characteristic | New ClearLLab 10C Reagent System<br>Subject Device | Predicate ClearLLab Reagents (5-color)<br>(De Novo DEN160047) |
|----------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------|
| | that can be used to set compensation in conjunction with the<br>Compensation Kit. | |
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| | | Table 2: Similarities and differences between Navios and its predicate | | |
|--|--|------------------------------------------------------------------------|--|--|
| Attribute | Navios Flow Cytometer<br>K130373 | Subject Navios Flow Cytometer |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA product code | OYE | OYE |
| Indications for Use | The Navios Flow Cytometer is intended for use as an in vitro<br>diagnostic device for immunophenotyping. It can be used in<br>conjunction with the following monoclonal antibody reagents<br>and software package:<br>CYTO-STAT tetraCHROME CD45-FITC/CD4-<br>RD1/CD8-ECD/CD3-PC5 and CYTO-STATE<br>tetraCHROME CD45-FITC/CD56-RD1/CD19-<br>ECD/CD3-PCD5 monoclonal antibody reagents. These<br>reagents provide identification and enumeration of<br>CD3+CD4+, CD3+CD8+, CD3+, CD19+ and CD3-<br>CD56+ lymphocyte percentages and absolute counts in<br>peripheral whole blood. Absolute counts may be<br>determined by the Navios flow cytometer using Flow-<br>Count Fluorospheres (single platform technology<br>method) or separate hematology results (dual platform<br>method). These reagents are indicated for use in the<br>immunologic assessment of patients having or<br>suspected of having immune deficiency. Navios tetra Software for automated analysis and<br>results with CYTO-STAT tetraCHROME CD45-<br>FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-<br>STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-<br>ECD/CD3-PC5 monoclonal antibody reagents. Navios Software may be installed on an independent computer<br>workstation for off-line analysis of listmode files generated by<br>the Navios Flow Cytometer with the monoclonal antibody<br>reagents and software package listed above. The off-line analysis<br>must be performed in accordance with the product labeling. | The Navios Flow Cytometer is intended for use as an in vitro<br>diagnostic device for immunophenotyping using up to ten<br>fluorescent detection channels using three lasers (488 nm, 638<br>nm and 405 nm) and two light scatter detection channels. It is<br>intended for use with in vitro diagnostic (IVD) assays and<br>software that are indicated for use with the instrument. |
| Safety Features | Interlocks and mitigation of hazards via software and hardware<br>controls | Same |
| Attribute | Navios Flow Cytometer<br>K130373…
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