(326 days)
Not Found
No
The summary describes a software update for a flow cytometer that includes risk control measures to detect signal loss or drift. The description of the software's function and the performance studies focus on rule-based detection and user review, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is a flow cytometer used for qualitative and quantitative measurement of properties of cells and other particles, specifically for in vitro diagnostic use, such as identifying and enumerating lymphocyte subpopulations. It is a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used for "qualitative and quantitative measurement of biological and physical properties of cells and other particles" and is "intended 'For In Vitro Diagnostic Use'", allowing for "identification and enumeration of lymphocyte subpopulations". This indicates its use in diagnosing or monitoring health conditions.
No
The device description explicitly states it is a "software update" to the "FC 500 Flow Cytometers," which are described as hardware devices utilizing lasers, sensors, and a flow cell to measure cell properties. The software update is intended to mitigate issues with the hardware's signal.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states that the systems with certain monoclonal antibody reagents are intended "For In Vitro Diagnostic Use".
- Purpose: The device is used for the qualitative and quantitative measurement of biological properties of cells, specifically for the identification and enumeration of lymphocyte subpopulations in whole blood. This type of analysis is performed on samples taken from the human body to provide information for diagnostic purposes.
- Components: The system includes reagents (monoclonal antibodies) and software specifically designed for analyzing these biological samples for diagnostic information.
The device description further supports this by detailing how the instrument measures properties of cells in a sample, which is a core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FC 500 MPL (K071681)
The Cytomics FC 500 MPL is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.
FC 500 MLC (K030828)
The tetraCXP SYSTEM for Cytomics FC 500 flow cytometry systems is an automated analysis method for simultaneous identification and enumeration of lymphocyte subpopulations (CD3+, CD4+, CD8+, CD19+ and CD56+) combining four-color fluorescent monoclonal antibody reagents, quality control reagents, optional absolute count reagent and CXP software. The systems with CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. The systems with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained. CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can obtained as well.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The FC 500 Flow Cytometer has two cleared configurations:
- MPL (Multi Plate Loader)
- This configuration manages sample preparations using 24 and 96 well plates as O well as 12 x 72mm tubes.
- The workstation contains MXP software for data acquisition, data O managements, instrument management, sample management and sample processing.
- MCL (Multi Carousel Loader)
- This configuration manages sample preparations using 12 x 72mm tubes in a 32 o tube carousel.
- The workstation contains the CXP software and receives data from the O Cytometer to display numeric results and dataplots. The CXP software also includes patient management, control management and LIS components.
Both devices use 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 one or two laser beams in single file. The instrument can simultaneously measure forward scatter, and five fluorescent dyes using one or two lasers at 488 nm and either 635 nm (solid-state laser) or 633 nm (HeNe laser). Therefore, the instrument can perform correlated multi-parameter analyses of individual cells.
To ensure that the cells move through the laser beam one at a time, the instrument uses hydrodynamic focusing in the flow cell. As the stream of sheath fluid is flowing through the flow cell, a stream of sample is injected into the middle of the sheath stream, The sheath stream surrounds, but does not mix with the sample stream, and its pressure focuses the sample stream so that the cells flow through the laser beam single file.
Before the laser beam reaches the sample stream, cross-cylindrical lenses focus the beam keeping it perpendicular to the sample stream flow while making the beam small enough to illuminate only one cell at a time.
As the cells in the sample stream go through the sensing area of the flow cell, the laser beam illuminates them. The cells scatter the laser light and emit fluorescent light from fluorescent dyes attached to them.
- The amount of laser light scattered at narrow angles to the axis of the laser beam is called forward scatter (FS) which is proportional to the size of the cell that scattered the light.
- The amount of laser light scattered at about a 90° angle to the axis of the laser beam is called side scatter (SS) which is proportional to the granularity of the cell that scattered the laser light (e.g., SS can be used to differentiate between lymphocytes, monocytes, and granulocytes).
- The cells also emit fluorescent light (FL) at all angles to the axis of the laser beam. The amount of FL enables the instrument to measure characteristics of the cells emitting the light, depending on the reagents used (e.g., FL can be used to identify molecules such as cell surface antigens).
The scattered laser light and fluorescent light are collected, separated and measured.
- The FS sensor collects the forward scatter. When the light reaches the FS sensor, the sensor generates voltage pulse signals which are proportional to the amount of light the sensor receives. The signals are processed to measure the characteristics of the cells that scattered the light.
- The pickup lens/spatial filter assembly collects SS and FL from the sensing area of the flow cell. Using a series of filters which reflect specific wavelengths of light towards their respective sensors and allow transmission of longer wavelengths of light, the SS and varying FL wavelengths (produced by fluorochromes such as FITC, PE, ECD, PC5, and ACD) are separated, collected, and measured.
The cytometer has seven sensors, each generating a voltage pulse signal as each cell passes through the laser beam. The voltage pulse signal is proportional to the intensity of the light the sensor received. The cytometer electronics amplify, condition, integrate and analyze these pulses.
The results of sample analysis appear on the workstation screen as graphs in which the user defines the parameters on the plot axes. To analyze the data, regions and gates are defined by the user to select the cells of interest, and then statistics are generated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Flow cytometry
Anatomical Site
Not Found
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 Title | Study Description and Outcomes |
|---|---|
| Pre-acquisition | The test method for the pre-acquisition study induced signal loss prior to the analysis of a sample run, and verified that the software detection tool (SDT) detected the failure, aborted the run and alerted the operator of the signal error. |
| Post-acquisition | The test method for the post-acquisition study consisted of 2 test cases utilizing the SDT during data acquisition to detect signal loss: 1) a combination of retrospective data imprinted with failure patterns characterized from field data and prospective sample runs processed through a modified instrument which allowed the user to induce random signal loss and 2) use of the SDT on an additional set of files that were deemed difficult to detect with the pre-mitigation data review instructions. These tests verified that the SDT identified data files with signal loss and alerted the user to review the data plots for the run. |
| Real World Data | The testing method for the real word data study applied the SDT to customer files sourced from the field and prospective testing performed with field returned boards with verifiable signal failure. Failures were then confirmed by visual review of the time plots. These tests verified that the SDT identified the failures as corroborated by the visual reviews. |
| Reader Study | The testing method for the reader study aligned the user instructions in the IFU for visual review of time plots. In this testing method, the multiple readers were blinded to review 10 files where 7 of these files contained signal loss undetectable by the SDT. Readers followed instructions on the assay IFU and addendum to visually assess the test files. This study confirmed that visual review of time plots identifies signal loss. |
The complementary performance studies confirm the process by which samples with signal loss are detected either prior to acquisition or appropriately quarantined by the SDT, postacquisition, for further review by the user. The use of the SDT, in addition to visual review of time plots provides a comprehensive solution. The studies demonstrated the safe and effective use of the SDT.
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
September 6, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Beckman Coulter Samy Puccio Staff Regulatory Affair Specialist 11800 SW 147th Avenue Miami, Florida 33196-2500
Re: K182886
Trade/Device Name: Cytomics FC 500 Series (MPL or MCL) Flow Cytometer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: December 14, 2018 Received: December 17, 2018
Dear Samy Puccio:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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,
Douglas Jeffery, Ph.D. Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182886
Device Name FC 500 MPL and MCL Flow Cytometers
Indications for Use (Describe)
The Cytomics FC 500 MPL is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.
The tetraCXP SYSTEM for Cytomics FC 500 flow cytometry systems is an automated analysis method for simultaneous identification and enumeration of lymphocyte subpopulations (CD3+, CD19+ and CD56+) combining fourcolor fluorescent monoclonal antibody reagents, quality control reagents, optional absolute count reagent and CXP software. The systems with CYTO-STAT tetraCHROME CD45-FITC/CD4-PD/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. The systems with CD45-FITC/CD56-PC/CD3-PC5, the total lymphocyte percentage can be obtained. CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can obtained as well.
| 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) |
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3
| Section 5 | 510(k) Summary |
|---|---|
Note:
Throughout this documentation the use of FC500 refers to both the FC500 MCL and FC 500 MPL unless otherwise noted.
4
510(k) Summary for The FC 500 Flow Cytometers Software Design Change
510(k) Owner / Submitter Information
Company Name: Beckman Coulter Inc. Address: 11800 SW 147th Ave., Miami, FL 33196 Phone #: (305) 380-4509 Fax #: (786) 639-4156 Contact Person: Samy Puccio Email Address: spuccio@beckman.com
Date Submitted:
December 14, 2018
Device Information
Trade Name: FC 500 MPL Flow Cytometer, FC 500 MCL Flow Cytometer Common Name: FC 500 Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: GKZ Panel: Hematology and Pathology Devices Panel
Predicate Device Information
| Predicate Product | 510(k)
Number | Date Cleared | Classification | 21 CFR | Product
Code |
|-------------------|------------------|--------------|----------------|----------|-----------------|
| FC 500 MPL | K071681 | Oct 4, 2007 | Class II | 864.5220 | GKZ |
| FC 500 MCL | K030828 | May 21, 2003 | Class II | 864.5220 | GKZ |
FC 500 Flow Cytometer
The FC 500 Flow Cytometer has two cleared configurations:
-
- MPL (Multi Plate Loader)
- This configuration manages sample preparations using 24 and 96 well plates as O well as 12 x 72mm tubes.
- The workstation contains MXP software for data acquisition, data O managements, instrument management, sample management and sample processing.
-
- MCL (Multi Carousel Loader)
5
- This configuration manages sample preparations using 12 x 72mm tubes in a 32 o tube carousel.
- The workstation contains the CXP software and receives data from the O Cytometer to display numeric results and dataplots. The CXP software also includes patient management, control management and LIS components.
Both devices use 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 one or two laser beams in single file. The instrument can simultaneously measure forward scatter, and five fluorescent dyes using one or two lasers at 488 nm and either 635 nm (solid-state laser) or 633 nm (HeNe laser). Therefore, the instrument can perform correlated multi-parameter analyses of individual cells.
To ensure that the cells move through the laser beam one at a time, the instrument uses hydrodynamic focusing in the flow cell. As the stream of sheath fluid is flowing through the flow cell, a stream of sample is injected into the middle of the sheath stream, The sheath stream surrounds, but does not mix with the sample stream, and its pressure focuses the sample stream so that the cells flow through the laser beam single file.
Before the laser beam reaches the sample stream, cross-cylindrical lenses focus the beam keeping it perpendicular to the sample stream flow while making the beam small enough to illuminate only one cell at a time.
As the cells in the sample stream go through the sensing area of the flow cell, the laser beam illuminates them. The cells scatter the laser light and emit fluorescent light from fluorescent dyes attached to them.
- The amount of laser light scattered at narrow angles to the axis of the laser beam is called forward scatter (FS) which is proportional to the size of the cell that scattered the light.
- The amount of laser light scattered at about a 90° angle to the axis of the laser beam is called side scatter (SS) which is proportional to the granularity of the cell that scattered the laser light (e.g., SS can be used to differentiate between lymphocytes, monocytes, and granulocytes).
- . The cells also emit fluorescent light (FL) at all angles to the axis of the laser beam. The amount of FL enables the instrument to measure characteristics of the cells emitting the light, depending on the reagents used (e.g., FL can be used to identify molecules such as cell surface antigens).
The scattered laser light and fluorescent light are collected, separated and measured.
- . The FS sensor collects the forward scatter. When the light reaches the FS sensor, the sensor generates voltage pulse signals which are proportional to the amount of light the sensor receives. The signals are processed to measure the characteristics of the cells that scattered the light.
- The pickup lens/spatial filter assembly collects SS and FL from the sensing area of the ● flow cell. Using a series of filters which reflect specific wavelengths of light towards
6
their respective sensors and allow transmission of longer wavelengths of light, the SS and varying FL wavelengths (produced by fluorochromes such as FITC, PE, ECD, PC5, and ACD) are separated, collected, and measured.
The cytometer has seven sensors, each generating a voltage pulse signal as each cell passes through the laser beam. The voltage pulse signal is proportional to the intensity of the light the sensor received. The cytometer electronics amplify, condition, integrate and analyze these pulses.
The results of sample analysis appear on the workstation screen as graphs in which the user defines the parameters on the plot axes. To analyze the data, regions and gates are defined by the user to select the cells of interest, and then statistics are generated.
Design Change Description:
This modification to the FC 500 Flow Cytometers is being implemented as part of corrective actions for a field action initiated by Beckman Coulter (BEC) in January 2018. The field action was issued on the FC 500 to notify customers that BEC received and confirmed reports of failures causing signal loss and/or signal drifting resulting in the absence of data or a shift in the population in the data plots.
As part of the corrective actions, BEC developed a software update that contains additional risk control measures for the device to mitigate the potential failure modes associated with the reported signal loss and/or signal drift.
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Intended Use/Indications for Use:
FC 500 MPL (K071681)
The Cytomics FC 500 MPL is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.
FC 500 MLC (K030828)
The tetraCXP SYSTEM for Cytomics FC 500 flow cytometry systems is an automated analysis method for simultaneous identification and enumeration of lymphocyte subpopulations (CD3+, CD4+, CD8+, CD19+ and CD56+) combining four-color fluorescent monoclonal antibody reagents, quality control reagents, optional absolute count reagent and CXP software. The systems with CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. The systems with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained. CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can obtained as well.
8
Comparison to Predicate:
The design changes applied to the FC 500 MPL and MCL Flow Cytometers serve as additional risk control measures to mitigate each of the potential failure modes identified in the root cause analysis of the field action that initiated these changes.
These design changes do not impact the intended use or performance claims of the FC 500 Flow Cytometers.
Device Comparison Table:
| Characteristic | FC500 MPL and MCL
( K071681 {MPL} & K030828 {MCL}, Predicate) | Proposed
Device |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Indications for use | K071681 (MPL)
The Cytomics FC 500 MPL is a system for the
qualitative and quantitative measurement of
biological and | Same |
| | K030828 (MCL)
The tetraCXP SYSTEM for Cytomics FC 500 flow
cytometry systems is an automated analysis method
for simultaneous identification and enumeration of
lymphocyte subpopulations (CD3+, CD4+, CD8+,
CD19+ and CD56+) combining four-color
fluorescent monoclonal antibody reagents, quality
control reagents, optional absolute count reagent and
CXP software. The systems with CYTO-STAT
tetraCHROME CD45-FITC/CD4-PE/CD8-
ECD/CD3-PC5 Monoclonal antibody reagent is
intended "For In Vitro Diagnostic Use", allowing the
identification and enumeration of Total CD3+ (T
cells), Total CD4+, Total CD8+, Dual CD3+/CD4+,
Dual CD3+/CD8+ lymphocyte percentages and
absolute counts as well as the CD4/CD8 ratio in
whole blood flow cytometry. The systems with
CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the
total lymphocyte percentage can be obtained. CD45-
FITC/CD56-PE/CD19-ECD/CD3-PC5 monoclonal | Same |
| | antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can obtained as well. | |
| Device
Classification &
Product Code | 21 CFR 864.5220 Automated Cell Counter, GKZ | Same for both |
| Manufacturer | Beckman Coulter | Same for both |
| Safety Features | Interlocks and mitigation of hazards via software and hardware controls | Same, with addition of changes as detailed in this submission |
| Sample Analysis | Principle of analysis – Flow cytometric Detection hardware - Lasers, fluidics, optics, electronics Sample analysis pathway | Same for both |
| Quality Control
Techniques | Daily Instrument Checks Commercial Controls Inter-laboratory Quality Assurance Program (IQAP) | Same for both |
| Controlling
software | System Software | Same for both |
| Syringe Type | K071681 (MPL)
500 µL Hamilton Syringe
K030828 (MCL)
no syringe | Same |
| Sample
Preparation | External to instrument | Same for both |
| Sample
presentation | K071681 (MPL)
12 x 75mm tubes, 24 or 96 well plate
K030828 (MCL)
12x77mm tubes in a 32 tube carousel | Same |
| Specimen Introduction | Specimens are loaded in the Autoloader using cassettes / or the single loader as single specimen tubes | Same for both |
| Prepared Sample Introduction | K071681 (MPL)
12 x 75mm tubes, 24 or 96 well plate
K030828 (MCL)
12x77mm tubes in a 32 tube carousel | Same |
| Specimen Identification | Barcode - positive sample identification or manual entry | Same for both |
| Prepared Sample Identification | K071681 (MPL)
Tracked by well position.
K030828 (MCL)
Tracked by tube location and barcode | Same |
| Resuspension of prepared sample prior to introduction to system | K071681 (MPL)
Prepared sample is mixed by the syringe using aspiration and dispense re-suspension
K030828 (MCL)
Stir motor | Same |
| Off-line analysis software | CXP analysis | Same for both |
| Instrument Quality Control Techniques | K071681 (MPL)
Flow Check
K030828 (MCL)
ClearLLab Flow Check Pro | Same |
| Standardization | A standardization check is performed on each QC per lab process or IFU | Same for both |
| Analytical Features | | |
| Off-line analysis software | Workstation also offered as off-line analysis software package | Same for both |
| Data Handling | Electronics and software required to support data handling | Same for both |
| Optics | Laser light delivered by mirrors, prisms, and lenses | Same for both |
| Data Processing | Region/gates evaluation Statistics generation Export of results to MS Excel | Same for both |
| Analysis Algorithm (Interface and Reports) | Interface to algorithms Algorithm results reporting | Same for both |
| User interface | Plots and reports | Same for both |
| Report generator | Panel reports QC | Same for both |
| Post-Analytical Features | | |
| Workstation | Software functionality to allow –
K071681 (MPL) System configuration management System service test and adjustment procedures | Same |
| | K030828 (MCL) Patient data management – storage, review, reporting to LIS Control data management – storage, review, reporting System configuration management System service test and adjustment procedures | Same |
9
10
11
12
Summary of Performance Testing:
The testing approaches were complementary to demonstrate safety and effectiveness. No guidance documents or standards were used to establish the test methods.
| Study Title | Study Description and Outcomes |
|---|---|
| Pre-acquisition | The test method for the pre-acquisition study induced signal loss prior to |
| the analysis of a sample run, and verified that the software detection tool | |
| (SDT) detected the failure, aborted the run and alerted the operator of the | |
| signal error. | |
| Post- | |
| acquisition | The test method for the post-acquisition study consisted of 2 test cases |
| utilizing the SDT during data acquisition to detect signal loss: 1) a | |
| combination of retrospective data imprinted with failure patterns | |
| characterized from field data and prospective sample runs processed | |
| through a modified instrument which allowed the user to induce random | |
| signal loss and 2) use of the SDT on an additional set of files that were | |
| deemed difficult to detect with the pre-mitigation data review | |
| instructions. These tests verified that the SDT identified data files with | |
| signal loss and alerted the user to review the data plots for the run. | |
| Real World | |
| Data | The testing method for the real word data study applied the SDT to |
| customer files sourced from the field and prospective testing performed | |
| with field returned boards with verifiable signal failure. Failures were | |
| then confirmed by visual review of the time plots. These tests verified | |
| that the SDT identified the failures as corroborated by the visual reviews. | |
| Reader Study | The testing method for the reader study aligned the user instructions in |
| the IFU for visual review of time plots. In this testing method, the | |
| multiple readers were blinded to review 10 files where 7 of these files | |
| contained signal loss undetectable by the SDT. Readers followed | |
| instructions on the assay IFU and addendum to visually assess the test | |
| files. This study confirmed that visual review of time plots identifies | |
| signal loss. |
The complementary performance studies confirm the process by which samples with signal loss are detected either prior to acquisition or appropriately quarantined by the SDT, postacquisition, for further review by the user. The use of the SDT, in addition to visual review of time plots provides a comprehensive solution. The studies demonstrated the safe and effective use of the SDT.
13
Substantial Equivalence Conclusion to Demonstrate Safety, Effectiveness & Equivalent Performance to Predicate:
The updates to the FC 500 that are the subject of this submission, do not change the intended use, nor add or delete a contraindication for the device. The changes do not alter the device control mechanism, operating principle, energy type, environmental specification, ergonomics of the user interface, dimensional specifications, nor packaging. The device does not have expiration dating nor is it subject to sterilization.
In summary, the updated FC 500 MPL and MCL Flow Cytometers, as described in this submission are substantially equivalent in terms of safety and effectiveness to the predicate devices.
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.