(86 days)
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
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.
The provided document describes the ClearLLab 10C Reagent System on the DxFLEX Flow Cytometer and its substantial equivalence to the predicate device, the ClearLLab 10C Reagent System on the Navios EX Flow Cytometer.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a single table labeled "Acceptance Criteria" and "Reported Device Performance" side-by-side with specific numerical thresholds for each criterion. Instead, it lists various studies, their objectives, and the "Testing Results" which indicate whether the device met the performance requirements.
However, we can infer the acceptance criteria from the objectives of the studies and the "Testing Results" column. The reported device performance is stated as meeting these requirements.
| Study (Criterion) | Objective (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Laser Performance Characteristics | Verify stability of the laser performance of the DxFLEX Flow Cytometer over time. (Acceptance: Laser performance is stable over time.) | Analysis of the data collected demonstrates that the DxFLEX Flow Cytometer laser performance is stable over time. |
| Instrument Carryover (Fluorospheres) | To verify carryover of the DxFLEX Daily QC Fluorospheres in specimens on the DxFLEX Flow Cytometer after running the required daily clean. (Acceptance: Meets carryover performance requirements for fluorospheres.) | 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. (Acceptance: Fluorescence detection is linear.) | Linearity of fluorescence measurements was demonstrated. |
| Carryover - Specimen and Reagent | To verify carryover of specimen and reagents on the DxFLEX Flow Cytometer meets performance specifications. (Acceptance: Meets carryover performance requirements for specimens and reagents.) | 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. (Acceptance: Meets performance requirements for differentiating abnormal and normal populations.) | 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. (Acceptance: Meets performance requirements for repeatability and reproducibility with control material.) | 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. (Acceptance: Meets performance requirements for repeatability and reproducibility with normal and clinical specimens.) | 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 | 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. (Acceptance: Acceptable precision performance and met acceptance criteria across operators and instruments.) | 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. (Acceptance: Able to identify the abnormal population when compared to the predicate.) | 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 | 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. (Acceptance: Appropriate target value ranges are defined, and a process for range transfer is in place.) | 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. |
Additional Requested Information:
-
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document doesn't explicitly state the specific sample sizes for all test sets. For "Precision - Operator and Instrument Variability," it mentions "the same specimen prepared by three (3) operators, twice a day, on two (2) DxFLEX Flow Cytometers." For "Clinical Accuracy," it mentions "specimens from donors in the intended use population" evaluated in a "multi-site evaluation."
- Data Provenance: The document does not specify the country of origin of the data. The "Clinical Accuracy" study states it used "specimens from donors in the intended use population," implying clinical samples. It does not state if the studies were retrospective or prospective, though "Multi-Site with Clinical Specimens" and "Clinical Accuracy" studies usually imply prospective collection for validation.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document states for the "Indications for Use" of the ClearLLab 10C Panels: "Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings."
- However, regarding the studies themselves, and specifically for establishing the ground truth for the test set used in the evaluations (e.g., in the Clinical Accuracy study), the document does not specify the number of experts, their qualifications, or their role in establishing ground truth. The "Clinical Accuracy" study compared the DxFLEX system to the predicate Navios EX, implying the predicate's results served as a comparative reference rather than an independent expert ground truth being explicitly defined for the DxFLEX data.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe any adjudication method used for the test set.
-
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This device is a flow cytometer and reagent system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed or mentioned in this document. The "Clinical Accuracy" study compared the new device to a predicate device, which is a different type of comparative study.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device described is an in vitro diagnostic device (flow cytometer and reagents) that generates qualitative data for immunophenotyping. The data analysis uses "Kaluza C data analysis software," but the "Interpretation of the results should be confirmed by a pathologist or equivalent professional." This indicates it is not a standalone algorithm in the sense of providing a final diagnosis without human interpretation. Performance studies were largely focused on the instrument and reagent's analytical capabilities, not a standalone diagnostic algorithm.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "Clinical Accuracy" study, the ground truth was essentially implied by comparison to the predicate device (Navios EX flow cytometer). The study aimed to demonstrate "performance equivalency" and "qualitative immunophenotype agreement" between the DxFLEX system and the cleared Navios EX system. While pathologists confirm interpretations, the studies described herein validate the device's performance against established methods, rather than generating a de novo ground truth from pathology and outcomes for every case.
-
8. The sample size for the training set
- The document does not mention a training set or its sample size. This type of submission (for a flow cytometer and reagent system) typically focuses on analytical and clinical validation studies, rather than machine learning model training.
-
9. How the ground truth for the training set was established
- As no training set is mentioned, information on how its ground truth was established is not provided.
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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).
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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
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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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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
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Predicate Device Information
| Predicate Product | 510(k)Number | DateCleared | Classification | 21 CFR | ProductCode |
|---|---|---|---|---|---|
| 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]
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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.
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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 onNavios EX flow cytometer (K183592) -Predicate | ClearLLab 10C Reagent Systemon DxFLEX flow cytometer |
|---|---|---|
| FDA product codefor ClearLLab 10CPanels | 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 forqualitative identification of various cellpopulations by immunophenotyping on the Naviosand Navios EX flow cytometers. These reagentsare used as an aid in the differential diagnosis ofhematologically abnormal patients having thefollowing hematopoietic neoplasms: chronicleukemia, acute leukemia, non-Hodgkinlymphoma, myeloma, myelodysplastic syndrome(MDS), and/or myeloproliferative neoplasms(MPN). The reagents can be used with peripheralwhole blood (collected in K2EDTA, ACD orHeparin), bone marrow (collected in K2EDTA,ACD or Heparin) and lymph node specimens forimmunophenotyping. The results should beinterpreted by a pathologist or equivalent inconjunction with other clinical and laboratoryfindings. | SAME (with the exception of cytometer)Intended for in vitro diagnostic use as a panel forqualitative identification of various cell populations byimmunophenotyping on the Navios, Navios EX andDxFLEX flow cytometers. These reagents are used as anaid in the differential diagnosis of hematologicallyabnormal patients having the following hematopoieticneoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome(MDS), and/or myeloproliferative neoplasms (MPN). Thereagents can be used with peripheral whole blood(collected in K2EDTA, ACD or Heparin), bone marrow(collected in K2EDTA, ACD or Heparin) and lymph nodespecimens for immunophenotyping. The results should beinterpreted by a pathologist or equivalent in conjunctionwith other clinical and laboratory findings. |
.
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| Characteristic | ClearLLab 10C Reagent System onNavios EX flow cytometer (K183592) -Predicate | ClearLLab 10C Reagent Systemon DxFLEX flow cytometer | |||
|---|---|---|---|---|---|
| Reagent Panels | B panelKAPPALAMBDACD10CD5CD200CD34CD38CD20CD19CD45 | T panelTCRγδCD4CD2CD56CD5CD34CD7CD8CD3CD45 | M1 panelCD16CD7CD10CD13CD64CD34CD14HLA-DRCD11bCD45 | M2 panelCD15CD123CD117CD13CD33CD34CD38HLA-DRCD19CD45 | ALL MARKERS ARE THE SAME |
| Reagent Form | Dry unitized form (one test / panel) | SAME | |||
| Storage Conditions | Room Temperature | SAME | |||
| Set-up ReagentsOptical and FluidicsAlignment | Flow-Check Pro Fluorospheres | SIMILARDxFLEX Daily QC FluorospheresSame function. Designed to be used on 10 channels of theDxFLEX flow cytometer | |||
| Set-up ReagentsStandardization | Flow-Set Pro Fluorospheres | SIMILARDxFLEX Daily QC FluorospheresThe standardization for the ClearLLab 10C ReagentSystem on the DxFLEX Flow Cytometer is performedwith the same reagent and during the same step as theoptical alignment and fluidics verification. |
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| Characteristic | ClearLLab 10C Reagent System onNavios EX flow cytometer (K183592) -Predicate | ClearLLab 10C Reagent Systemon DxFLEX flow cytometer | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DxFLEX Daily QC Fluorospheres have target valuesassigned to monitor optical alignment and fluidics that arealso used as an aid in standardizing forward scatter, sidescatter, and fluorescence detectors on the DxFLEX FlowCytometer. | ||||||||||||||||||||||||||||||||
| Lyse and Fixation | IOTest 3 Fixative SolutionIOTest 3 Lysing Solution | SAME | ||||||||||||||||||||||||||||||
| Sample Preparation | Wash and prepare samples manually | SAME | ||||||||||||||||||||||||||||||
| Sample Age andPrepared SampleStability | 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 ClearLLabCompensation Beads | SAME, except with labeling changes to include DxFLEXFlow Cytometer only | ||||||||||||||||||||||||||||||
| Control cells | ClearLLab Control cells (normal and abnormal) | SAME, except with labeling changes to include DxFLEXFlow Cytometer and assay ranges specific for theDxFLEX Flow Cytometer |
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| Attribute | Navios EX Flow Cytometer(K183592) | DxFLEX Flow Cytometer |
|---|---|---|
| FDA productcode for FlowCytometer | OYE | OYE |
| Intended Use | The Navios EX Flow Cytometer is intended for use asan in vitro diagnostic device for immunophenotypingusing up to ten fluorescent detection channels usingthree lasers (488 nm, 638 nm, and 405 nm) and twolight scatter detection channels. It is intended for usewith in vitro diagnostic (IVD) assays and software thatare indicated for use with the instrument. | The DxFLEX Flow Cytometer is intended for use as an invitro diagnostic device for immunophenotyping using upto ten fluorescent detection channels using three lasers(488 nm, 638 nm, and 405 nm) and two light scatterdetection channels. It is intended for use with in vitrodiagnostic (IVD) assays and software that are indicatedfor use with the instrument. |
| Safety Features | Interlocks and mitigation of hazards via software andhardware controls | SAME |
| SoftwareArchitecture | The acquisition software enables the user to acquiredata from the instrument and to analyze, display, printand export acquired data.The embedded software resides in the instrument. Itcontrols the instrument functionality including themulti-carousel loader (MCL) for sample introduction.The embedded software controls the instruments' lasers,acquisition system and fluidics. The instrument fluidicsaspirates the sample, and performs instrumentmaintenance functions such as startup/shutdown. Theembedded software also captures and provides the datato the workstation for processing. | SAME |
| Pre-Analytic Features | ||
| Attribute | Navios EX Flow Cytometer(K183592) | DxFLEX Flow Cytometer |
| SystemConfiguration | 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 |
| SamplePreparation | Off-board sample preparation following instructions provided with cleared antibody reagent | SAME |
| SamplePresentation | Sample prepared in dry reagent tube presented in the same tube | SAME |
| Resuspension ofprepared sampleprior tointroduction tosystem | Prepared sample is vortex mixed | SAME |
| SampleIntroduction | 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 |
| SampleIdentification | Bar-code reading of carousel position and labeled sample tube. User may also identify samples based on carousel location with a worklist. | SAME |
| AspirationPathway | Same aspiration pathway used for automated and manual presentation | Using peristaltic pump for automatic presentation |
| SampleAspirationProbe | Adjustable (by Beckman Coulter field service personnel) | Adjustable (both Beckman Coulter field service personnel and user) |
| Analytical Features | ||
| Lasers / DriverBoards | 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 AngleLight 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 |
| Fluorescencecollection | 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 bandsPMTs detect light and convert to electrical signals | APDs (Avalanche Photodiodes) detect light and convert to electrical signals | |
| MaximumParameterDetectors | Twelve (Forward Scatter, Side Scatter and 10 fluorescence channels) | Twelve (Forward Scatter, Side Scatter and 10 fluorescence channels) |
| Electronics | 40 MHz sampling | 25 MHz samplingClearLLab 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 |
| ColorSeparation | 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-boardacquisitionsoftware | System Software available | SAME |
| AnalysisSoftware | Kaluza C data analysis software to be used with theClearLLab 10C application and to be used off-line. | SAME, except provided analysis protocols will bespecific for ClearLLab Reagents on DxFLEX FlowCytometer |
| Navios EX on-board and off-line analysis software isnot recommended for use of control cell and sampledata analysis. | CytExpert for DxFLEX software will not berecommended for use of control cell and sample dataanalysis. | |
| Post-Analytical Features | ||
| Data Reporting | Report, Plots and Statistics printouts | SAME |
| Cleaning CycleBetweenSamples | Executed with Sheath Fluid ensuring carryoverspecification is met | SAME |
| Quality ControlTechniques | Daily Instrument Checks Supplied Controls for ClearLLab 10C application | SAME |
| Cleanse Cycle | Cleaning cycle performed with FlowClean cleaningreagent as part of the daily shutdown process, beforeand after running samples with vital dyes that stain thetubing, and as part of troubleshooting. | SAME, except additional cleaning cycle required afterrunning DxFLEX Daily QC Fluorospheres |
| Reagents usedforcompensationand samplepreparation | ClearLLab Compensation Kit and Compensation Beadswill be used with the ClearLLab 10C application. | SAME, except with labeling changes to include DxFLEXFlow Cytometer only |
| Attribute | Navios EX Flow Cytometer(K183592) | DxFLEX Flow Cytometer |
| Assay Controlsand Calibrators | Flow-Check Pro FluorospheresFlow-Set Pro Fluorospheres | SIMILARDxFLEX Daily QC Fluorospheres have target valuesassigned to monitor optical alignment and fluidics and toaid in standardization. |
| ProcessControls | ClearLLab Control Cells (Normal and Abnormal) | SAME except with labeling changes to include DxFLEXFlow Cytometer and assay ranges specific for theDxFLEX Flow Cytometer |
| Instrument Software | ||
| Processor | PowerPC | SAME |
| ProgrammingLanguage | C++ | C# C++ |
| RTOS | VxWorks | N/A |
| WorkstationInterface | Ethernet | USB Ethernet |
| DataAcquisition | 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 |
| ControlSoftware | 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 AccountControl | 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. |
| Reportgenerator | Panel reports & QC | SAME |
Technological Characteristics Comparisons, Subject Instrument to Predicate
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- 510(k) Submission for ClearLLab 10C Reagent System on the DxFLEX Flow Cytometer 510(k) Summary
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Summary of Instrument Characterization and Analytical Performance Testing
| Study | Testing Approach | FDA Guidance Documents | Standards/ References | Testing Results |
|---|---|---|---|---|
| Laser PerformanceCharacteristics | Verify stability of the laserperformance of the DxFLEXFlow Cytometer over time. | None | None | Analysis of the data collected demonstratesthat the DxFLEX Flow Cytometer laserperformance is stable over time. |
| Instrument Carryover | To verify carryover of theDxFLEX Daily QCFluorospheres in specimenson the DxFLEX FlowCytometer after running therequired daily clean | Special Controls GuidanceDocument: PremarketNotifications for AutomatedDifferential Cell Countersfor Immature or AbnormalBlood Cells - Carryover(Section 12) | CLSI H26-A2; FDA StandardsRecognition #7-210 | Analysis of the data collected demonstratesthat the DxFLEX Flow Cytometer meets thecarryover performance requirements. |
| Instrument Linearity | Verify fluorescence detectionis linear using standardDxFLEX Flow Cytometersettings. | None | None | Linearity of fluorescence measurements wasdemonstrated. |
| Study | Objective | FDA Guidance Documents | Standards/ References | Testing Results |
| Carryover - Specimen andReagent | To verify carryover ofspecimen and reagents on theDxFLEX Flow Cytometermeets performancespecifications. | Special Controls GuidanceDocument: PremarketNotifications forAutomated DifferentialCell Counters for Immatureor Abnormal Blood Cells -Carryover (Section 12) | Validation, Verification, andQuality Assurance of AutomatedHematology Analyzers, ApprovedStandard - 2nd Edition; June 2010;CLSI H26-A2; FDA StandardsRecognition #7-210 | Analysis of the data collected demonstratesthat the DxFLEX Flow Cytometer meetscarryover performance requirements. |
| Detection Capability | To verify that the ClearLLab10C Reagent System on theDxFLEX Flow Cytometermeet the performancerequirements for the ability todifferentiate betweenabnormal and normalpopulations. | None | Wood B et al. Validation of Cell-Based Fluorescence Assays:Practice Guidelines from the ICSHand ICCS - Part V - Assayperformance Criteria. CytometryPart B (Clinical Cytometry), pp.315-323 | Analysis of the data collected demonstratesthat the ClearLLab 10C Reagent System onthe DxFLEX Flow Cytometer meet theperformance requirements for DetectionCapability. |
| Precision - ControlMaterial | Demonstrate systemimprecision using controlmaterial as a surrogate for astabilized sample | Special Controls GuidanceDocument: PremarketNotifications forAutomated DifferentialCell Counters for Immatureor Abnormal Blood Cells -Precision (Section 9) | CLSI EP05-A3. Evaluation ofPrecision of QuantitativeMeasurement Procedures:Approved Guideline – ThirdEdition. FDA StandardsRecognition #7-251 | Analysis of the data collected demonstratesthat the ClearLLab 10C Reagent System onthe DxFLEX Flow Cytometer meetsperformance requirements for repeatabilityand reproducibility. |
| Precision - Multi-Site withClinical Specimens | Demonstrate assayrepeatability andreproducibility using bothnormal and clinicalspecimens. | Special Controls GuidanceDocument: PremarketNotifications forAutomated DifferentialCell Counters for Immatureor Abnormal Blood Cells -Precision (Section 9) | CLSI EP05-A3, Evaluation ofPrecision of QuantitativeMeasurement Procedures;Approved Guideline – ThirdEdition. FDA StandardsRecognition #7-251User Protocol for Evaluation ofQualitative Test Performance;Approved Guideline - Second | Analysis of the data collected demonstratesthat the ClearLLab 10C Reagent System onthe DxFLEX Flow Cytometer meetsperformance requirements for repeatabilityand reproducibility. |
| Study | Objective | FDA Guidance Documents | Standards/ References | Testing Results |
| Precision - Operator andInstrument Variability | Demonstrate systemimprecision performance ofthe ClearLLab 10C ReagentSystem on the DxFLEX FlowCytometer using the samespecimen prepared by three(3) operators, twice a day, ontwo (2) DxFLEX FlowCytometers. | Special Controls GuidanceDocument: PremarketNotifications forAutomated DifferentialCell Counters for Immatureor Abnormal Blood Cells -Precision (Section 9) | CLSI EP05-A3, Evaluation ofPrecision of QuantitativeMeasurement Procedures;Approved Guideline – ThirdEdition. FDA StandardsRecognition #7-251User Protocol for Evaluation ofQualitative Test Performance;Approved Guideline - SecondEdition; CLSI EP12-A2; FDAStandards Recognition #7-152 | The ClearLLab 10C Reagent System, whenrun on each specimen type by differentoperators on different DxFLEX FlowCytometers, demonstrated acceptableprecision performance and met acceptancecriteria. |
| Clinical Accuracy | Demonstrate the performanceequivalency betweenClearLLab 10C ReagentSystem on DxFLEXcytometers (Test Method) andNavios EX flow cytometers(Predicate Method) by amulti-site evaluation of thequalitative immunophenotypeagreement between the twosystems using specimens fromdonors in the intended usepopulation. | None | CLSI H43-A2: Clinical FlowCytometric Analysis of NeoplasticHematolymphoid Cells - SecondEdition; FDA StandardsRecognition #7-150User Protocol for Evaluation ofQualitative Test Performance;Approved Guideline - SecondEdition; CLSI EP12-Ed3; FDAStandards Recognition #7-315CLSI EP09-A3: MeasurementProcedure Comparison and BiasEstimation Using Patient Samples;Approved Guideline-3rd Edition;FDA Standards Recognition #7-296 | Analysis of the data collected demonstratesthat the ClearLLab 10C panels are ableidentify the abnormal population whencompared to the predicate. |
| Study | Objective | FDA Guidance Documents | Standards/ References | Testing Results |
| DxFLEX Daily QCFluorospheres AnalyteValue Assignment | Define DxFLEX Daily QCFluorospheres Target Valueranges for use with theClearLLab 10C ReagentSystem and define a processfor ranges transfer from onelot of DxFLEX Daily QCFluorospheres. | None | None | Analysis of the data collected demonstratesthat appropriate DxFLEX Daily QCFluorospheres Target Value ranges aredefined for use with the ClearLLab 10CReagent System and that a process for rangetransfer from one lot of DxFLEX Daily QCFluorospheres to another one is in place. |
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Summary of System Performance Testing:
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Summary of Accessory Reagents Performance Testing:
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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.
§ 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.”