(216 days)
No
The document describes standard flow cytometry technology and software for data analysis and reporting. There is no mention of AI or ML algorithms being used for data processing, interpretation, or decision-making. The software is described as having "automated analysis and results" but this refers to predefined algorithms for identifying and enumerating cell populations based on fluorescence and scatter properties, not AI/ML.
No
Explanation: The device is intended for use as an in vitro diagnostic device for immunophenotyping, specifically for identifying and enumerating lymphocyte percentages and absolute counts in peripheral whole blood for the immunologic assessment of patients. This indicates a diagnostic rather than a therapeutic function.
Yes.
The "Intended Use / Indications for Use" section explicitly states "The Navios Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping." It also mentions its use in the "immunologic assessment of patients having or suspected of having immune deficiency."
No
The device description clearly lists multiple hardware components as part of the system, including the Navios Flow Cytometer, TQ-Prep Workstation, and PrepPlus™ 2 Workstation. While software is a component, it is not the sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Navios Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping."
Furthermore, the intended use involves analyzing biological samples (peripheral whole blood) to provide information for the diagnosis or assessment of immune deficiency, which is a typical application for IVD devices. The associated reagents and software are also described as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
Navios Flow Cytometer
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 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 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
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.
Product codes (comma separated list FDA assigned to the subject device)
OYE, PDX
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 tetraCHROME 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
| Study | Study Design | Study Results |
|---|---|---|
| Accuracy | Based on CLSI EP9-A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition. | The Navios flow cytometer demonstrated comparable results to the predicate device with CYTO-STAT tetraCHROME 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 of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. |
- Whole Blood Repeatability | The Navios flow cytometer demonstrated acceptable results with CYTO-STAT tetraCHROME Reagents. |
| Linearity | 1) Based on CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. - Pairs of ImmunoBrite beads and Ultra Rainbow Calibration particles evaluated across the dynamic range of each detector. | The Navios flow cytometer demonstrated acceptable linearity results. |
| Assay and Instrument Carryover | Based on recommendations contained in CLSI H26-A2, Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Guideline-Second Edition; Section 5.7 – Carryover | The Navios flow cytometer demonstrated acceptable carryover results. |
| Specimens | Specimens tested over the sample stability and | Acceptable sample and prepared sample stability results achieved. |
| Reference Values | Based on CLSI C28-A3, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, Approved Guideline – Third Edition | Reference intervals established. |
| Single vs. Dual Platform Absolute Counting Method Comparison | Based on CLSI EP15 | Demonstrated comparable absolute count results from single and dual platform methods. |
| Laser Performance Characterization | Evaluated mean channel values for FS and fluorescence detectors measured for integral signal intensity variation and half peak coefficient of variation (HPCV). | Acceptable laser performance characterization results achieved. |
| Limits | Based on the CLSI EP17-A2 Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved.Guideline | 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 | Based on CLSI EP15 | Demonstrated comparable results are achieved when specimens are prepared using a manual pipette and PrepPlus 2 workstation. |
| Open and Closed Vial Stability | Evaluated open and closed vial stability of multiple lots of Flow-Set Pro Fluorospheres over the shelf life of the product on a Navios flow cytometer. | Flow-Set Pro Fluorospheres demonstrated acceptable results. |
| Analyte Value Assignment | Using iterative process, established target value ranges for Flow-Set Pro Fluorospheres with Navios tetra software. | Established process for generating target value ranges for Navios tetra software. |
| FC 500 Flow Cytometer Usage | Established target channel and ranges for Flow-Set Pro Fluorospheres on an FC 500 flow cytometer and used them for daily instrument standardization according to instructions provided in product labeling. | Demonstrated acceptable results with Flow-Set Pro Fluorospheres on an FC 500 flow cytometer. |
| Precision | Based on CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. | Flow-Set Pro Fluorospheres demonstrated acceptable results. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
0
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 Cytometer | |||
| with Navios tetra software | |||
| and Navios software (off- | |||
| line analysis software) | Cytomics FC 500 | ||
| with tetraCXP | |||
| software | Beckman | ||
| Coulter, Inc. | K030828 | ||
| Flow-Set Pro | |||
| Fluorospheres | Flow-Set | ||
| Fluorospheres | Beckman | ||
| Coulter, Inc. | K944751 |
1
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) .
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.
2
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.
6.0 Intended Use:
Navios Flow Cytometer
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 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
3
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
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.
4
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 500
flow cytometry systems and CYTO-STAT
tetraCHROMETM CD45-FITC/CD4-RD1/CD8-
ECD/CD3-PC5 and CYTO-STAT
tetraCHROMETM CD45-FITC/CD56-
RD1/CD19-ECD/CD3-PC5 Monoclonal
Antibody Reagents combine four-color
fluorescent monoclonal antibody reagents,
quality control reagents, an optional absolute
count reagent, and software for automated
analysis of lymphocyte populations in whole
blood using Cytomics FC 500 flow cytometry
systems with CXP Software.
The system with.CYTO-STAT tetraCHROME
CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 is
intended "For In Vitro Diagnostic Use" and
allows simultaneous identification and
enumeration of total CD3+, total CD4+, total
CD8+, dual CD3+/CD4+ and dual CD3+/CD8+
T lymphocyte population percentages and
absolute counts.
The system with CYTO-STAT tetraCHROME
CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 | Navios Flow Cytometer:
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 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. |
| Attribute | FC 500 flow cytometer (Predicate) | Navios flow cytometer |
| Device
Classification
and Product
Code | is intended "For In Vitro Diagnostic Use" and
allows simultaneous identification and
enumeration of total CD3+ (T), CD19+ (B), and
CD3-/CD56+ (NK) lymphocyte population
percentages and absolute counts. This reagent
reflects the distribution of the three major
subsets comprising the lymphocyte population
upon which other lymphocyte enumeration
studies are based and provides the total
lymphocyte percentage. | 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. |
| | 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 sampling
Analog integrator circuitry w/ late stage ADC
Yields ~1,500 events/sec | 40 MHz sampling
Digital integrator circuitry w/ early stage ADC
Yields ~25,500 events/sec |
| Quality
Control
Techniques | 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 |
5
.
Volume 005, Page 7 of 14
.
6
Beckman Coulter, Inc.
Navios Flow Cytometer System
510(k) Submission
Volume 005, Page 8 of 14
7
Flow-Set Pro Fluorospheres
| Attribute | Flow-Set Fluorospheres
(Predicate) | Flow-Set Pro Fluorospheres |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Flow-Set Fluorospheres are a suspension of
Fluorospheres (fluorescent microspheres) used
as an aid in optimizing a flow cytometer for
quantitative analysis of human leukocytes. | 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
Classification
and Product
Code | 864.8625, Hematology Quality Control
Mixture, JPK | 864.5220, Automated Differential Cell Counter,
PDX |
| Reagent
Components | 3.6 µm (nominal diameter) polystyrene
fluorospheres suspended in an aqueous medium
containing surfactants and preservatives at 1 x
106 fluorospheres/mL (nominal concentration) | Same except 3 µm (nominal diameter) polystyrene
fluorospheres |
| Fluorescence
Emission | Ranges from 525 nm to 700 nm when excited at
488 nm | Ranges from 515-800 nm when excited at 488 nm |
| Suspension
solution | Aqueous medium containing surfactants and
preservatives at 1 x 106 fluorospheres/mL
(nominal concentration) | Same |
| Manufacturing
Process | Polymerized in the presence of a single, broad
spectrum dye. | Manufactured by loading a solution of three dyes
into a polystyrene particle. |
| Bead
Fluorochromes | Rubicene dye | Rubicene dye, IR-676 dye, Perylene dye |
| Laboratory
instrument
standardization | Establishing Fluorescence and/or Light
Scatter Target Ranges
Establishing Instrument HV/ Total Gain | Same |
| Attribute | Flow-Set Fluorospheres (Predicate) | Flow-Set Pro Fluorospheres |
| Applicable Instruments | Ranges
• Daily Instrument Standardization
Cytomics FC 500
Epics XL/XL-MCL | Navios
Cytomics FC 500
Same |
| 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
:
8
Beckman Coulter, Inc.
Navios Flow Cytometer System
510(k) Submission
.
Volume 005, Page 10 of 14
:
·
9
Summary of Performance Data 8.0
| Study | Study Design | Study Results |
|---|---|---|
| Accuracy | Based on CLSI EP9-A2, Method Comparison | |
| and Bias Estimation Using Patient Samples; | ||
| Approved Guideline – Second Edition. | The Navios flow cytometer demonstrated comparable | |
| results to the predicate device with CYTO-STAT | ||
| tetraCHROME 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 of | |
| Precision Performance of Quantitative | ||
| Measurement Methods; Approved Guideline – | ||
| Second Edition. |
- Whole Blood Repeatability | The Navios flow cytometer demonstrated acceptable
results with CYTO-STAT tetraCHROME Reagents. |
| Linearity | 1) Based on CLSI EP06-A, Evaluation of the
Linearity of Quantitative Measurement
Procedures: A Statistical Approach; Approved
Guideline. - Pairs of ImmunoBrite beads and Ultra
Rainbow Calibration particles evaluated across
the dynamic range of each detector. | The Navios flow cytometer demonstrated acceptable
linearity results. |
| Assay and
Instrument
Carryover | Based on recommendations contained in CLSI
H26-A2, Validation, Verification, and Quality
Assurance of Automated Hematology
Analyzers; Approved Guideline-Second
Edition; Section 5.7 – Carryover | The Navios flow cytometer demonstrated acceptable
carryover results. |
| Specimens | Specimens tested over the sample stability and | Acceptable sample and prepared sample stability
results achieved. |
| Study | Study Design | Study Results |
| Reference
Values | Based on CLSI C28-A3, Defining,
Establishing, and Verifying Reference
Intervals in the Clinical Laboratory, Approved
Guideline – Third Edition | Reference intervals established. |
| Single vs. Dual
Platform
Absolute
Counting
Method
Comparison | Based on CLSI EP15 | Demonstrated comparable absolute count results
from single and dual platform methods. |
| Laser
Performance
Characterization | Evaluated mean channel values for FS and
fluorescence detectors measured for integral
signal intensity variation and half peak
coefficient of variation (HPCV). | Acceptable laser performance characterization results
achieved. |
| Limits | Based on the CLSI EP17-A2 Protocols for
Determination of Limits of Detection and
Limits of Quantitation; Approved.Guideline | 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 | Based on CLSI EP15 | Demonstrated comparable results are achieved when
specimens are prepared using a manual pipette and
PrepPlus 2 workstation. |
| Study | Study Design | Study Results |
| Open and
Closed Vial
Stability | Evaluated open and closed vial stability of
multiple lots of Flow-Set Pro Fluorospheres
over the shelf life of the product on a Navios
flow cytometer. | Flow-Set Pro Fluorospheres demonstrated acceptable
results. |
| Analyte Value
Assignment | Using iterative process, established target
value ranges for Flow-Set Pro Fluorospheres
with Navios tetra software. | Established process for generating target value ranges
for Navios tetra software. |
| FC 500 Flow
Cytometer
Usage | Established target channel and ranges for
Flow-Set Pro Fluorospheres on an FC 500 flow
cytometer and used them for daily instrument
standardization according to instructions
provided in product labeling. | Demonstrated acceptable results with Flow-Set Pro
Fluorospheres on an FC 500 flow cytometer. |
| Precision | Based on CLSI EP5-A2, Evaluation of
Precision Performance of Quantitative
Measurement Methods; Approved Guideline –
Second Edition. | Flow-Set Pro Fluorospheres demonstrated acceptable
results. |
10
Volume 005, Page 12 of 14
:
11
ow-Set Pro Fluorospheres
·
Beckman Coulter, Inc.
Navios Flow Cytometer System
510(k) Submission
.
.
/olume 005, Page 13 of 14
:
12
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.
13
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
14
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
15
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)
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 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)
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
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)
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.
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.