The Navios Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It can be used in conjunction with the following monoclonal antibody reagents and software package:
• CYTO-STAT letraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT terrCHROME CD45-FITC/CD56-F • C Y (O-S FAT TetraCHKOME CD4-FFTCCO4+KD7/CDV-Fc2/CD3 P ovide identification and numeration of CD3+CD4+CD4+CD4+CD4+CD4+ KDI/CDI9-ECD/CD3+CS monocolal antibody reagains. There reges and absolute counts in peripleral whole blood. Absolute method) CD3+CD8+, CD3+, CD19+ and CD3-CD3+ Tymphoeyto percomes (single platform lections of the may be in closing acrescription of parient counts may be celermined by the Navio Cyclinece asng I to "Outlier" (o" on the in the immunologic assessment of patients having or suspected of having immune deficiency.
• Navios tetra Software for automated and results with CYTO-STAT terraCHRONE CD45-FFTC/CD4-RD/VCD8-ECD/CD3-FCD/CD3-• Navios letta Soltware for adionated and results will of 10 0 010 11:40 pm
PC5 and CYTO-STAT ietraCHROME CD45 FITC/CD56-RDI/CD19-ECD/CD3-PCS monoclonal antibody reagents.
PC
Navios Software may be installed on an independent computer workstarion for off issues of listed of line against must he Navios Soltware may be installed on the incependent compaise frectorial and software package listed above. The off-line analysis must be performed in accordance with the product labeling.

The Navios tetra Software is intended for use as an in vitro diagnostic device for immunophenoyping with CYTC/CDS6 RD/A The Navios tera Software is mielided to use as an in Thir Glightshouse on minutes of the Subsition of the National Provincial Provinces of CD19-FITC/CD56-RDI/CD19-ECV/ CD3-PC5 monoclonal antibody reagents on the Navios Flow Cytometer.
It provides automated analysis and results for the identification and enumeration of CD3+CD4+, CD19+, CD19+, and If provides and results for the nemation and while blood. Absolute counts may be determined by the except of the CD3+CD5+ iymphocyte percentages and alsolute counts in perfined in separate hematology results (dual Navios now cycomerer use in the immunologic assessment of patients having or suspected of having immune deficiency.
platform method). It is indicated for use in the immunolog

Flow-Set Pro Fluorospheres is a suspension of fluorescent microspheres used as an aid in standardizing forward scatter, side scatter, and fluorescence detectors (FL1-4) on the Cytomics FC 500 and Navios Flow Cytometers.

Device Description

The Navios Flow Cytometer system is composed of the following components:

Navios Flow Cytometer .
Navios tetra Software .
Navios Software (off-line analysis tool) .
Flow-Set Pro Fluorospheres .
CYTO-STAT teiraCHROME reagents .
COULTER IMMUNOPREP Reagent System .
TQ-Prep Workstation (Accessory for Sample Preparation) .
PrepPlus™ 2 Workstation (Accessory for Sample Preparation) .

The Navios Flow Cytometer uses flow cytometric principles to determine qualitative and quantitative measurements of biological and physical properties of cells and other particles. These properties are measured when the cells pass through the laser beam(s) in single file.

The Navios tetra software is an optional locked algorithm application plug-in that is designed for the Navios flow cytometer. It provides automated analysis and results for tetraCHROME reagents; this application cannot be modified by the user.

The Navios Flow Cytometry System also offers an optional standalone offline software package, Navios software, which may be installed on an independent computer workstation for off-line analysis of listmode files generated by the Navios Flow Cytometer with tetraCHROME reagents and Navios tetra software according to the product labeling.

tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 CYTO-STAT reagent provides identification and enumeration of CD3+CD4+, CD3+CD8+, and CD3+ lymphocyte percentages and absolute counts in peripheral whole blood. CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 reagent provides identification and enumeration of CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in peripheral whole blood.

Flow-Set Pro Fluorospheres is a suspension of fluorospheres with uniform and stable size and fluorescence intensity. The stability of these product parameters allows for the standardization of light scatter and fluorescence intensity instrument settings.

The COULTER ImmunoPrep Reagent System is comprised of 3 ready-to-use reagents: Reagent A lyses the red blood cells, Reagent B buffers the solution and stops the lysing process, and Reagent C fixes the cells. This reagent system provides a rapid, no-wash, standardized, whole blood lysing solution for sample to sample, and laboratory to laboratory reproducibility.

The Navios Flow Cytometer uses sample preparation devices as part of the overall workflow system. The COULTER TQ-Prep Workstation is used with the COULTER ImmunoPrep Reagent System to prepare leukocytes from whole blood for quantitative immunofluorescence measurements on flow cytometers. The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Navios Flow Cytometer System, based on the provided text.

Acceptance Criteria and Device Performance

The submission details several studies conducted to demonstrate the performance of the Navios Flow Cytometer system. The "Study Results" column in the table below directly indicates if the device met acceptable results for the respective criteria.

Study (Acceptance Criteria)	Reported Device Performance
Accuracy (Method Comparison)	The Navios flow cytometer demonstrated comparable results to the predicate device with CYTO-STAT tetraCHROME Reagents.
Precision (Repeatability)	The Navios flow cytometer demonstrated acceptable results with CYTO-STAT tetraCHROME Reagents.
Linearity	The Navios flow cytometer demonstrated acceptable linearity results.
Assay and Instrument Carryover	The Navios flow cytometer demonstrated acceptable carryover results.
Specimens (Sample Stability)	Acceptable sample and prepared sample stability results achieved.
Reference Values (Establishment)	Reference intervals established.
Single vs. Dual Platform Absolute Counting Method Comparison	Demonstrated comparable absolute count results from single and dual platform methods.
Laser Performance Characterization	Acceptable laser performance characterization results achieved.
Limits (of Detection & Quantitation)	Established the Limit of Blank, Limit of Detection and Low Limit of Quantitation values for each tetraCHROME marker when tested on the Navios system.
Manual Pipette vs. PrepPlus 2 Method Comparison	Demonstrated comparable results are achieved when specimens are prepared using a manual pipette and PrepPlus 2 workstation.
Open and Closed Vial Stability (Flow-Set Pro Fluorospheres)	Flow-Set Pro Fluorospheres demonstrated acceptable results.
Analyte Value Assignment (Flow-Set Pro Fluorospheres)	Established process for generating target value ranges for Navios tetra software.
FC 500 Flow Cytometer Usage (Flow-Set Pro Fluorospheres)	Demonstrated acceptable results with Flow-Set Pro Fluorospheres on an FC 500 flow cytometer.
Precision (Flow-Set Pro Fluorospheres)	Flow-Set Pro Fluorospheres demonstrated acceptable results.

Study Information

The document is a 510(k) summary, which typically provides a high-level overview of validation studies rather than detailed protocols. As such, some specific details like exact sample sizes for training/test sets, data provenance, and expert qualifications are not explicitly stated in the provided text.

1. Sample Sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated in the provided text. The "Accuracy" study mentions using "Patient Samples" based on CLSI EP9-A2. The "Precision" study used "Whole Blood Repeatability." The "Manual Pipette vs. PrepPlus 2 Method Comparison" also used "specimens." However, the exact number of samples or patients for any of these studies is not provided.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective validation studies conducted by the manufacturer, Beckman Coulter, Inc.

2. 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)

Not explicitly stated. Given that the device is an "Automated Differential Cell Counter" for immunophenotyping, the ground truth would likely be established through a recognized reference method performed by trained laboratory personnel on an established, validated system. The document compares performance to a predicate device (Cytomics FC 500 with tetraCXP software), implying that the predicate's results served as a comparative "ground truth" or reference.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not explicitly stated. Adjudication methods are typically relevant for subjective interpretations (e.g., image analysis by multiple radiologists). For quantitative measurements from a flow cytometer, the ground truth is usually derived from a reference method with inherent analytical precision, rather than adjudicated expert opinions.

4. 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

No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance. The Navios system is an automated flow cytometer with software for automated analysis (Navios tetra software). The comparisons are between the new device and a predicate device (another automated system), and between different methods on the same device (e.g., single vs. dual platform absolute counting) or different sample preparation methods. This is not a human-in-the-loop AI system where human reader performance would be the primary metric.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, standalone performance was assessed. The entire suite of performance studies (Accuracy, Precision, Linearity, Carryover, Limits, etc.) for the Navios Flow Cytometer and its associated Navios tetra software (which is an "optional locked algorithm application plug-in that is designed for the Navios flow cytometer. It provides automated analysis and results") represent standalone algorithm performance. The device is intended "for automated analysis and results."

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The ground truth for the analytical performance studies (Accuracy, Precision, Linearity, etc.) appears to be based on:
- Comparison to a predicate device: The accuracy study directly states "comparable results to the predicate device." The predicate device (Cytomics FC 500 with tetraCXP software) represents an established and accepted method for immunophenotyping.
- Established analytical methods and guidelines: Studies refer to CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., CLSI EP9-A2 for Method Comparison, CLSI EP5-A2 for Precision, CLSI EP06-A for Linearity). These guidelines define methods to establish the true analytical performance characteristics of a quantitative diagnostic device, implicitly establishing a "true value" or "ground truth" to compare against.
- Reference Intervals: Reference intervals were established for the device, which involves testing healthy populations to define normal ranges.

7. The sample size for the training set

Not explicitly stated. The document describes performance studies, which are typically conducted on independent test sets after an algorithm has been developed and trained. Information about specific training set sizes used to develop the "Navios tetra software" algorithm is not provided in this regulatory summary.

8. How the ground truth for the training set was established

Not explicitly stated. As this is a 510(k) summary focused on post-development performance validation, details on the training process and ground truth establishment for the development phase of the "Navios tetra software" algorithm are not included. Generally, for such systems, training data would be meticulously characterized using established laboratory methods or reference instruments, with expert review to ensure accuracy of the labels.

Summary

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10130373

Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the words "BECKMAN COULTER" on the right. The graphic is a black circle with two white curved lines running through it. The text is in a bold, sans-serif font, with "BECKMAN" on top of "COULTER".

510(k) Summary Navios™ Flow Cytometer System

1.0 Submitted By:

Nancy Nadler Director. Regulatory Affairs Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4191 FAX: (305) 380-3618

SEP 1 8 2013

2.0 Date Submitted:

February 13, 2013

Device Name - Classification 3.0

Navios™ Flow Cytometer with Navios tetra software and Navios software (offline software package) – Automated Differential Cell Counter, OYE (21 CFR § 864.5220)

Flow-Set™ Pro Fluorospheres – Automated Differential Cell Counter, PDX (21 CFR § 864.5220)

Predicate Devices: 4.0

Candidate	Predicate	Manufacturer	Docket Number
Navios Flow Cytometerwith Navios tetra softwareand Navios software (off-line analysis software)	Cytomics FC 500with tetraCXPsoftware	BeckmanCoulter, Inc.	K030828
Flow-Set ProFluorospheres	Flow-SetFluorospheres	BeckmanCoulter, Inc.	K944751

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5.0 Description:

The Navios Flow Cytometer system is composed of the following components:

Navios Flow Cytometer .
Navios tetra Software .
Navios Software (off-line analysis tool) .
Flow-Set Pro Fluorospheres .
CYTO-STAT teiraCHROME reagents .
COULTER IMMUNOPREP Reagent System .
TQ-Prep Workstation (Accessory for Sample Preparation) .
PrepPlus™ 2 Workstation (Accessory for Sample Preparation) .

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6.0 Intended Use:

Navios Flow Cytometer

CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-. PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 monoclonal antibody reagents. These reagents provide identification and enumeration of CD3+CD4+, CD3+CD8+, CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in peripheral whole blood. Absolute counts may be determined by the Navios flow cytometer using Flow-Count Fluorospheres (single platform technology method) or separate hematology results (dual platform method). These reagents are indicated for use in the immunologic assessment of patients having or suspected of having immune deficiency.
Navios tetra Software for automated analysis and results with CYTO-. STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 monoclonal antibody reagents.

Navios Software may be installed on an independent computer workstation for off-line analysis of listmode files generated by the Navios Flow Cytometer with the monoclonal antibody reagents and software package listed above. The off-line analysis must be performed in accordance with the product labeling.

Navios tetra Software

The Navios tetra Software is intended for use as an in vitro diagnostic device for immunophenotyping with CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/ CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 monoclonal antibody reagents on the Navios Flow Cytometer.

It provides automated analysis and results for the identification and enumeration of CD3+CD4+, CD3+CD8+, CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in peripheral whole blood. Absolute counts may

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be determined by the Navios flow cytometer using Flow-Count Fluorospheres (single platform technology method) or separate hematology results (dual platform method). It is indicated for use in the immunologic assessment of patients having or suspected of having immune deficiency.

Flow-Set Pro Fluorospheres

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lomparison to Predicate 7.0

Navios Flow Cytometer with Navios tetra Software and Navios Analysis Software

Attribute	FC 500 flow cytometer(Predicate)	Navios flow cytometer
Intended Use	FC 500 Flow Cytometer with tetraCXP software:The tetraCXP Software for Cytomics FC 500flow cytometry systems and CYTO-STATtetraCHROMETM CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STATtetraCHROMETM CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 MonoclonalAntibody Reagents combine four-colorfluorescent monoclonal antibody reagents,quality control reagents, an optional absolutecount reagent, and software for automatedanalysis of lymphocyte populations in wholeblood using Cytomics FC 500 flow cytometrysystems with CXP Software.The system with.CYTO-STAT tetraCHROMECD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 isintended "For In Vitro Diagnostic Use" andallows simultaneous identification andenumeration of total CD3+, total CD4+, totalCD8+, dual CD3+/CD4+ and dual CD3+/CD8+T lymphocyte population percentages andabsolute counts.The system with CYTO-STAT tetraCHROMECD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5	Navios Flow Cytometer:The Navios Flow Cytometer is intended for use as anin vitro diagnostic device for immunophenotyping. Itcan be used in conjunction with the followingmonoclonal antibody reagents and software package:CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 andCYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5monoclonal antibody reagents. These reagentsprovide identification and enumeration ofCD3+CD4+, CD3+CD8+, CD3+, CD19+ andCD3-CD56+ lymphocyte percentages andabsolute counts in peripheral whole blood.Absolute counts may be determined by theNavios flow cytometer using Flow-CountFluorospheres (single platform technologymethod) or separate hematology results (dualplatform method). These reagents areindicated for use in the immunologicassessment of patients having or suspected ofhaving immune deficiency.
Attribute	FC 500 flow cytometer (Predicate)	Navios flow cytometer
DeviceClassificationand ProductCode	is intended "For In Vitro Diagnostic Use" andallows simultaneous identification andenumeration of total CD3+ (T), CD19+ (B), andCD3-/CD56+ (NK) lymphocyte populationpercentages and absolute counts. This reagentreflects the distribution of the three majorsubsets comprising the lymphocyte populationupon which other lymphocyte enumerationstudies are based and provides the totallymphocyte percentage.	Navios tetra Software for automated analysisand results with CYTO-STAT tetraCHROMECD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5monoclonal antibody reagents. Navios Software may be installed on an independentcomputer workstation for off-line analysis oflistmode files generated by the Navios FlowCytometer with the monoclonal antibody reagentsand software package listed above. The off-lineanalysis must be performed in accordance with theproduct labeling.
	864.5220, Automated Differential Cell Counter,GKZ	864.5220, Automated Differential Cell Counter, OYE
Optics	Free space delivery and collection of laser light	Same except collection also uses fiber optics
Electronics	200 KHz samplingAnalog integrator circuitry w/ late stage ADCYields ~1,500 events/sec	40 MHz samplingDigital integrator circuitry w/ early stage ADCYields ~25,500 events/sec
QualityControlTechniques	Daily Instrument Checks Commercial Controls Inter-laboratory Quality Assurance Program (IQAP)	Same
Attribute	FC 500 flow cytometer (Predicate)	Navios flow cytometer
Sample Introduction	Automated presentation with Multi-tube Carousel Loader (MCL) from 32 test tube capacity carousel Manual presentation into a tube location on MCL via tube access door	Same
Sample Analysis	Principle of analysis - Flow cytometric Detection hardware - Lasers, fluidics, optics, electronics Sample analysis pathway Manual gating of cellular populations by user or automated gating of cellular populations with algorithmic software	Same
Automated algorithm analysis for tetraCHROME reagents	tetraCXP software	Navios tetra software
Accessories	Optional software kits for analysis on off-line workstations	Same

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Volume 005, Page 7 of 14

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Beckman Coulter, Inc.
Navios Flow Cytometer System
510(k) Submission

Volume 005, Page 8 of 14

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Flow-Set Pro Fluorospheres

Attribute	Flow-Set Fluorospheres(Predicate)	Flow-Set Pro Fluorospheres
Intended Use	Flow-Set Fluorospheres are a suspension ofFluorospheres (fluorescent microspheres) usedas an aid in optimizing a flow cytometer forquantitative analysis of human leukocytes.	Flow-Set Pro Fluorospheres is a suspension offluorescent microspheres used as an aid instandardizing forward scatter, side scatter, andfluorescence detectors (FL1-4) on the Cytomics FC500 and Navios Flow Cytometers.
DeviceClassificationand ProductCode	864.8625, Hematology Quality ControlMixture, JPK	864.5220, Automated Differential Cell Counter,PDX
ReagentComponents	3.6 µm (nominal diameter) polystyrenefluorospheres suspended in an aqueous mediumcontaining surfactants and preservatives at 1 x106 fluorospheres/mL (nominal concentration)	Same except 3 µm (nominal diameter) polystyrenefluorospheres
FluorescenceEmission	Ranges from 525 nm to 700 nm when excited at488 nm	Ranges from 515-800 nm when excited at 488 nm
Suspensionsolution	Aqueous medium containing surfactants andpreservatives at 1 x 106 fluorospheres/mL(nominal concentration)	Same
ManufacturingProcess	Polymerized in the presence of a single, broadspectrum dye.	Manufactured by loading a solution of three dyesinto a polystyrene particle.
BeadFluorochromes	Rubicene dye	Rubicene dye, IR-676 dye, Perylene dye
Laboratoryinstrumentstandardization	Establishing Fluorescence and/or LightScatter Target RangesEstablishing Instrument HV/ Total Gain	Same
Attribute	Flow-Set Fluorospheres (Predicate)	Flow-Set Pro Fluorospheres
Applicable Instruments	Ranges• Daily Instrument StandardizationCytomics FC 500Epics XL/XL-MCL	NaviosCytomics FC 500Same
Sample Preparation	Must be thoroughly mixed prior to use. Samples in test tubes which stand for an extended period of time should be vortex mixed before use. No other sample preparation is necessary.	Same
Target Value Ranges	Procedure provided for user to establish target value ranges for each manually gated application.Additionally, target value ranges provided for algorithm-based IVD software applications such as tetraCXP for FC 500 flow cytometer	Same as Flow-Set with target value ranges provided for Navios tetra software
Final Product Form	Liquid, ready to use	Same
Open Vial Stability	65 days	Same
Closed Vial Stability	18 months	10 months

Beckman Coulter, Inc.
Navios Flow Cytometer System
510(k) Submission

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Beckman Coulter, Inc.
Navios Flow Cytometer System
510(k) Submission

Volume 005, Page 10 of 14

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Summary of Performance Data 8.0

Study	Study Design	Study Results
Accuracy	Based on CLSI EP9-A2, Method Comparisonand Bias Estimation Using Patient Samples;Approved Guideline – Second Edition.	The Navios flow cytometer demonstrated comparableresults to the predicate device with CYTO-STATtetraCHROME Reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19/ECD/CD3-PC5).
Precision	1) Based on CLSI EP5-A2, Evaluation ofPrecision Performance of QuantitativeMeasurement Methods; Approved Guideline –Second Edition.2) Whole Blood Repeatability	The Navios flow cytometer demonstrated acceptableresults with CYTO-STAT tetraCHROME Reagents.
Linearity	1) Based on CLSI EP06-A, Evaluation of theLinearity of Quantitative MeasurementProcedures: A Statistical Approach; ApprovedGuideline.2) Pairs of ImmunoBrite beads and UltraRainbow Calibration particles evaluated acrossthe dynamic range of each detector.	The Navios flow cytometer demonstrated acceptablelinearity results.
Assay andInstrumentCarryover	Based on recommendations contained in CLSIH26-A2, Validation, Verification, and QualityAssurance of Automated HematologyAnalyzers; Approved Guideline-SecondEdition; Section 5.7 – Carryover	The Navios flow cytometer demonstrated acceptablecarryover results.
Specimens	Specimens tested over the sample stability and	Acceptable sample and prepared sample stabilityresults achieved.
Study	Study Design	Study Results
ReferenceValues	Based on CLSI C28-A3, Defining,Establishing, and Verifying ReferenceIntervals in the Clinical Laboratory, ApprovedGuideline – Third Edition	Reference intervals established.
Single vs. DualPlatformAbsoluteCountingMethodComparison	Based on CLSI EP15	Demonstrated comparable absolute count resultsfrom single and dual platform methods.
LaserPerformanceCharacterization	Evaluated mean channel values for FS andfluorescence detectors measured for integralsignal intensity variation and half peakcoefficient of variation (HPCV).	Acceptable laser performance characterization resultsachieved.
Limits	Based on the CLSI EP17-A2 Protocols forDetermination of Limits of Detection andLimits of Quantitation; Approved.Guideline	Established the Limit of Blank, Limit of Detectionand Low Limit of Quantitation values for eachtetraCHROME marker when tested on the Naviossystem
Manual Pipettevs. PrepPlus 2MethodComparison	Based on CLSI EP15	Demonstrated comparable results are achieved whenspecimens are prepared using a manual pipette andPrepPlus 2 workstation.
Study	Study Design	Study Results
Open andClosed VialStability	Evaluated open and closed vial stability ofmultiple lots of Flow-Set Pro Fluorospheresover the shelf life of the product on a Naviosflow cytometer.	Flow-Set Pro Fluorospheres demonstrated acceptableresults.
Analyte ValueAssignment	Using iterative process, established targetvalue ranges for Flow-Set Pro Fluorosphereswith Navios tetra software.	Established process for generating target value rangesfor Navios tetra software.
FC 500 FlowCytometerUsage	Established target channel and ranges forFlow-Set Pro Fluorospheres on an FC 500 flowcytometer and used them for daily instrumentstandardization according to instructionsprovided in product labeling.	Demonstrated acceptable results with Flow-Set ProFluorospheres on an FC 500 flow cytometer.
Precision	Based on CLSI EP5-A2, Evaluation ofPrecision Performance of QuantitativeMeasurement Methods; Approved Guideline –Second Edition.	Flow-Set Pro Fluorospheres demonstrated acceptableresults.

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Volume 005, Page 12 of 14

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ow-Set Pro Fluorospheres

Beckman Coulter, Inc.
Navios Flow Cytometer System
510(k) Submission

/olume 005, Page 13 of 14

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The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.

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 2 l CFR 807.92.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

September 18, 2013

BECKMAN COULTER, INC. C/O MS. NANCY NADLER 11800 S.W. 147 AVENUE M/S 31-B06 MIAMI, FL 33196-2500

Re: K130373

Trade/Device Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Dated: Received:

Navios Flow Cytometer System 21 CFR 864.5220 Automated Differential Cell Counter Class II OYE, PDX August 14, 2013 August 16, 2013

Dear Ms. Nadler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 – Ms. Nancy Nadler

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you decire specific ac and Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Reena Phillip -S

for Maria M. Chan, Ph.D.

Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K130373

Device Name Navios™ Flow Cytometer

Indications for Use (Describe)

• CYTO-STAT letraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT terrCHROME CD45-FITC/CD56-F • C Y (O-S FAT TetraCHKOME CD4-FFTCCO4+KD7/CDV-Fc2/CD3 P ovide identification and numeration of CD3+CD4+CD4+CD4+CD4+CD4+ KDI/CDI9-ECD/CD3+CS monocolal antibody reagains. There reges and absolute counts in peripleral whole blood. Absolute method) CD3+CD8+, CD3+, CD19+ and CD3-CD3+ Tymphoeyto percomes (single platform lections of the may be in closing acrescription of parient counts may be celermined by the Navio Cyclinece asng I to "Outlier" (o" on the in the immunologic assessment of patients having or suspected of having immune deficiency.

• Navios tetra Software for automated and results with CYTO-STAT terraCHRONE CD45-FFTC/CD4-RD/VCD8-ECD/CD3-FCD/CD3-• Navios letta Soltware for adionated and results will of 10 0 010 11:40 pm
PC5 and CYTO-STAT ietraCHROME CD45 FITC/CD56-RDI/CD19-ECD/CD3-PCS monoclonal antibody reagents.
PC

Navios Software may be installed on an independent computer workstarion for off issues of listed of line against must he Navios Soltware may be installed on an incependent compaise frectorial and software package listed above. The off-line analysis must be performed in accordance with the product labeling.

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Sic Lung Chan ; S 04'00 2013.09.18 10:02:05

FORM FDA 3881 (6/13)

{16}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K130373

Device Name Navios™ tetra Sofware

Indications for Use (Describe)

It provides automated analysis and results for the identification and enumeration of CD3+CD4+, CD19+, CD19+, and If provides and results for the nemation and while blood. Absolute counts may be determined by the except of the CD3+CD5+ iymphocyte percentages and alsolute counts in perfined in separate hematology results (dual Navios now cycomerer use in the immunologic assessment of patients having or suspected of having immune deficiency.
platform method). It is indicated for use in the immunolog

Type of Use (Select one or both, as applicable)

🇿 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 80) Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sic Lung Chan - Sic 2013.09.18 10:03:43 -04'00'

FORM FDA 3881 (6/13)

PSC Publishing Senites (301) 44) 6740 EFF

{17}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K130373

Device Name

Flow-Set™ Pro Fluorospheres

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sic Lung Chan 2013.09!18 110:02:48 -04'00'

FORM FDA 3881 (6/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

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