The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

The BD FACSLyric™ flow cytometer with the integrated BD FACSDuet™ System is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) aser. It includes an automated sample preparation system used to prepare human peripheral whole blood samples for acquisition and analysis and is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

Device Description

The BD FACSLyric™ Flow Cytometer is a flow cytometer system. The BD FACSLyric™ Flow Cytometer with the integrated BD FACSDuet™ Sample Preparation System includes the flow cytometer and an automated sample preparation system. The system includes the BD FACSLyric™ Flow Cytometer, BD FACSTM Universal Loader, BD FACSuite™ Clinical software, BD FACSDuet™ Sample Preparation System, BD Multitest™ 6- Color and 4-Color Assay Modules, BD® FACSFlow™ Sheath Fluid, BD® CS&T Beads, and BD® FC Beads 7-Color Kit. It uses flow cytometry and immunofluorescence assay methodology.

AI/ML Overview

Here's an analysis of the acceptance criteria and study data from the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "All acceptance criteria were met" or "The acceptance criteria were met" for each study, but it does not explicitly list the specific numerical acceptance criteria for each performance metric. It only provides the objective of each study.

Study	Acceptance Criteria (Objective)	Reported Device Performance
Analytical Performance
Within-site Precision	To evaluate the within-site precision performance of FACSLyric flow cytometer with FACSDuet instrument.	All acceptance criteria were met.
Whole Blood Repeatability	To verify repeatability performance of FACSLyric flow cytometer with FACSDuet instrument using HIV+ patient and normal whole blood specimens.	Repeatability performance was demonstrated across all the instruments.
Linearity	To evaluate the linear range of FACSLyric flow cytometer with FACSDuet instrument.	The linear range of FACSLyric flow cytometer with FACSDuet instrument was established based on the acceptance criteria.
Limit of Blank (LoB) and Limit of Detection (LoD)	To evaluate the LoB and LoD of FACSLyric flow cytometer with FACSDuet instrument.	LoB and LoD of FACSLyric flow cytometer with FACSDuet instrument were established, and met the acceptance criteria.
Limit of Quantitation (LoQ)	To evaluate the LoQ of FACSLyric flow cytometer with FACSDuet instrument.	LoQ of the FACSLyric flow cytometer with the FACSDuet instrument was established, and met the acceptance criteria.
In-Use Reagent Stability Performance	To evaluate the in-use reagent stability of the Multitest 6-Color TBNK in the FACSDuet instrument.	All acceptance criteria were met.
Equivalency between 15 and 30 minutes Incubation Time	To demonstrate equivalency between 15 and 30 minutes staining incubation time using manual and FACSDuet sample preparation.	All acceptance criteria were met.
Specimen Carryover	To evaluate the specimen to specimen and bleach to specimen carryover in FACSDuet instrument.	All acceptance criteria were met.
Reagent Carryover	To evaluate the reagent carryover in FACSDuet instrument.	All acceptance criteria were met.
Pipette Dispense Accuracy and Precision	To evaluate the dispense accuracy and precision performance of FACSDuet instrument.	All acceptance criteria were met.
Clinical Performance
Method Comparison	To evaluate performance equivalency between FACSLyric flow cytometer with FACSDuet instrument (subject device), and FACSLyric flow cytometer with manual sample preparation (predicate device).	A total of 399 enrolled specimens were tested across 3 sites. 29 samples were non-evaluable. The acceptance criteria were met.
Inter-laboratory Reproducibility	To evaluate inter-laboratory reproducibility for FACSLyric flow cytometer with FACSDuet instrument.	The results demonstrated that the variability across three sites, and results met the acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Whole Blood Repeatability: Used "HIV+ patient and normal whole blood specimens." The sample size for each group is not specified.
Method Comparison: "A total of 399 enrolled specimens were tested across 3 sites." Data provenance (country of origin, retrospective/prospective) is not specified.
Inter-laboratory Reproducibility: "variability across three sites." The number of samples for this study is not explicitly stated, but it likely overlaps with or is a subset of the 399 specimens from the Method Comparison study if performed at the same sites.
Other analytical studies (Within-site Precision, Linearity, LoB/LoD, LoQ, In-Use Reagent Stability, Equivalency between Incubation Times, Specimen Carryover, Reagent Carryover, Pipette Dispense Accuracy and Precision) do not specify sample sizes or data provenance in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is an automated differential cell counter (flow cytometer) for immunophenotyping. The performance studies described involve analytical measurements and comparisons between automated and manual sample preparation, not expert interpretation of outputs to establish ground truth in the same way an imaging AI might. Ground truth for immunophenotyping would typically be derived from the inherent properties of the biological samples or established reference methods.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not relevant for the type of performance studies described for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs Without AI Assistance

Not applicable. An MRMC study is typically for evaluating the diagnostic performance of a device (often imaging AI) when used by human readers, and comparing performance with and without AI assistance. This device is an automated instrument with an automated sample preparation system, not an AI intended to assist human interpretation in a diagnostic workflow where "readers" are involved.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described are essentially "standalone" in the sense that they evaluate the performance of the automated system itself (the BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation System) in performing immunophenotyping, either against its manually-prepared equivalent or against established analytical standards. There is no human-in-the-loop component described for these performance evaluations.

7. The Type of Ground Truth Used

The ground truth for the performance studies appears to be based on:

Reference Methods/Established Standards: This is implied by adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., CLSI EP05-A3, CLSI EP6-A, CLSI EP17-A2, CLSI H26-A2, CLSI EP25-A, CLSI EP09c). These guidelines typically involve comparing the device's output to known values, spiked samples, or established reference systems.
Comparison to Predicate Device: For the "Method Comparison" study, the ground truth is essentially the performance of the predicate device (FACSLyric flow cytometer with manual sample preparation), since the objective is to demonstrate equivalency with the new automated system.
Inherent Sample Properties: For studies like "Whole Blood Repeatability," the ground truth is the expected inherent stability and consistency of measurements from the human whole blood specimens (HIV+ and normal).

8. The Sample Size for the Training Set

The document does not mention a "training set" as it would for a machine learning or AI device. The validation of the device's performance is described, but the underlying development and calibration data (which might be analogous to a training set for a traditional instrument) are not detailed.

9. How the Ground Truth for the Training Set Was Established

As no "training set" is explicitly mentioned in the context of AI/ML, this question is not applicable. For traditional medical devices, the "ground truth" during development (which could be considered analogous to training) is typically established through rigorous analytical testing and adherence to predefined specifications and accepted scientific principles for instrument calibration and performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 28, 2020

Becton, Dickinson and Company Niya Su Senior Manager, Regulatory Affairs 2350 Oume Drive San Jose, California 95131

Re: K201814

Trade/Device Name: BD FACSLyric Flow Cytometer BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: OYE Dated: June 30, 2020 Received: July 1, 2020

Dear Niya Su:

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 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,

Ying (Katelin) Mao, PhD 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

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Indications for Use

510(k) Number (if known) K201814

Device Name BD FACSLyric™ Flow Cytometer

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K201814

Device Name

BD FACSLyric™ Flow Cytometer with the integrated BD FACSDuet™ Sample Preparation System

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

This 510(k) summary is being provided in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

Date of Summary: August 31, 2020

1. Submitted By

BD Biosciences 2350 Qume Drive San Jose, CA 95131-1807 USA

Contact:	Niya Su
	Senior Manager, Regulatory Affairs
Telephone:	(206)779-7758
Fax:	(408)954-2347
Email:	Niya.Su@BD.com

2. Device

Trade Name/Device Name:

BD FACSLyricTM Flow Cytometer ●
BD FACSLyric™ Flow Cytometer with the integrated BD FACSDuet™ ● Sample Preparation System

Classification: Class II

Device Classification: Flow Cytometric Reagents and Accessories Regulation Description: Automated Differential Cell Counter Regulation Medical Specialty: Hematology Product Code: OYE Regulation Number: 21 CFR 864.5220

3. Predicate Device

Trade Name/Device Name: BD FACSLyricTM Flow Cytometer

Classification: Class II Device Classification: Flow Cytometric Reagents and Accessories Regulation Description: Automated Differential Cell Counter Regulation Medical Specialty: Hematology Product Code: OYE Regulation Number: 21 CFR 864.5220

4. Device Modification

Table 1 contains an overview of FACSLyric flow cytometer system components and device modification covered by this 510(k).

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System component	Cleared inK170974	Modification of this Special510(k)
BD FACSLyric™ Flow Cytometer	Yes	Modified
BD FACSTM Universal Loader	Yes	Modified
BD FACSuite™ Clinical software	Yes	Modified
BD FACSDuet™ Sample PreparationSystem (hereinafter referred to asFACSDuet instrument)	No	Modified (new instrument)
BD Multitest™ 6- Color and 4-ColorAssay Modules	Yes	Not affected
BD® FACSFlow™ Sheath Fluid	Yes
BD® CS&T Beads	Yes
BD® FC Beads 7-Color Kit	Yes

Table 1. FACSLyric Flow Cytometer System Components and Device Modification

The cleared FACSLyric flow cytometer will be modified as follows:

Modification 1: Minor changes to FACSuite Clinical software, FACSLyric Cytometer Management System (CMS) firmware and FACS Universal Loader hardware to allow for the integration with FACSDuet instrument.
. Modification 2: The addition of FACSDuet instrument as an optional automated sample preparation accessory to FACSLyric Flow Cytometer.

The intended/indications for use, fundamental scientific technology, acquisition and analysis on FACSLyric flow cytometer system are the same as the predicate device.

FACSDuet instrument is an automated sample preparation instrument that is data integrated with FACSLyric flow cytometer, and may also be physically integrated. It is an optional accessory to the FACSLyric flow cytometer system. FACSDuet instrument will be used with BD Multitest reagents (which utilized the FDA's draft guidance, Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices, issued on December 18, 2017) for use on FACSLyric flow cytometer.

5. Indications for Use

5.1 BD FACSLyric Flow Cytometer, FACS Universal Loader, FACSuite Clinical Software, Multitest 6-Color and 4-Color Assay Modules, FACSFlow Sheath Fluid, and CS&T Beads

The same as the predicate device.

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5.2 BD FACSLvric Flow Cytometer with the integrated BD FACSDuet Sample Preparation System

The BD FACSLyric flow cytometer with the integrated BD FACSDuet Sample Preparation System is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It includes an automated sample preparation system used to prepare human peripheral whole blood samples for acquisition and analysis and is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

5.3 BD FC Beads 7-Color Kit

The same as the predicate device with minor correction in the statement.

The BD FC Beads 7-Color kit (BD FC Beads), in conjunction with BD FACSuite Clinical software and BD CS&T beads, is used to establish fluorescence compensation for the BD FACSLyric flow cytometer.

6. Multiple Functions Device

The following statement is provided, according to the FDA draft guidance, Multiple Function Device Products: Policy and Considerations, dated April 27, 2018.

The products have functions subject to FDA premarket review and functions that are not subject to FDA premarket review. For this application, FDA assessed functions not subject to premarket review only insofar as they might adversely impact the safety and effectiveness of the functions subject to FDA premarket review.

7. Substantial Equivalence Comparison between Subject Devices and Predicate Device

A comparison of the similarities and differences between the subject devices and the predicate device is presented in Table 2.

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Feature/Attribute	Predicate DeviceFACSLyric Flow Cytometer(K170974)	Subject Device/Modified DeviceFACSLyric Flow Cytometer	Subject Device/Modified DeviceFACSLyric Flow Cytometer with theintegrated FACSDuet SamplePreparation System
		Flow Cytometer System
DeviceClassification andProduct Code	Automated Differential Cell Counter• Regulatory Class: II• Regulation Number: 21 CFR 864.5220• Product Code: OYE	Same	Same
AssayMethodology	Flow Cytometry	Same	Same
Detection/AssayPrinciple	Immunofluorescence	Same	Same
IntendedUse/Indicationsfor Use	The BD FACSLyric flow cytometer isintended for use as an in vitro diagnosticdevice for immunophenotyping using upto six fluorescence detection channels andtwo light scatter channels using a blue(488-nm) and a red (640-nm) laser. It isintended for use with in vitro diagnostic(IVD) assays* and software that areindicated for use with the instrument.	Same	The BD FACSLyricTM flow cytometer withthe integrated BD FACSDuetTM SamplePreparation System is intended for use asan in vitro diagnostic device forimmunophenotyping using up to sixfluorescence detection channels and twolight scatter channels using a blue (488-nm)and a red (640-nm) laser. It includes anautomated sample preparation systemused to prepare human peripheral wholeblood samples for acquisition andanalysis and is intended for use with invitro diagnostic (IVD) assays and softwarethat are indicated for use with theinstrument.
Specimen Type	Peripheral whole blood	Same	Same
Sample Volume	50 µL	Same	Same
Feature/Attribute	Predicate DeviceFACSLyric Flow Cytometer(K170974)	Subject Device/Modified DeviceFACSLyric Flow Cytometer	Subject Device/Modified DeviceFACSLyric Flow Cytometer with theintegrated FACSDuet SamplePreparation System
OpticalConfigurations	• 2-laser (blue, red), 4-color (3-1)• 2-laser (blue, red), 6-color (4-2)• 3-laser (blue, red, violet), 8-color (4-2-2)• 3-laser (blue, red, violet), 10-color (4-3-3)Only up to six detection channels usingred and blue lasers are for IVD use	Same, plus additional 3 laser (blue, red,violet), 12-color (4-3-5) configuration	Same, plus additional 3 laser (blue, red,violet), 12-color (4-3-5) configuration
MaximumParameterDetectors	IVD detection channels – SixFluorescence channels plus forwardscatter and side scatter	Same	Same
IVDLasers/Excitation	Blue Laser:• Wavelength: 488 nm• Optical power: 20mWRed Laser:• Wavelength: 640 nm• Optical power: 40 mW	Same	Same
Electronics	Up to 35000 events, sec	Same	Same
Forward ScatterDetection	Photodiode with built in 488/10 bandpassfilter	Same	Same
Feature/Attribute	Predicate DeviceFACSLyric Flow Cytometer(K170974)	Subject Device/Modified DeviceFACSLyric Flow Cytometer	Subject Device/Modified DeviceFACSLyric Flow Cytometer with theintegrated FACSDuet SamplePreparation System
Fluorescence andSide ScatterDetection	Side scatter and fluorescence Reflective optics with single transmission bandpass filter in front of each PMT High performance PMT modules for all fluorescence and side scatter channels Light collected by objective lens is delivered by fiber optics especially designed detector arrays The cuvette flow cell is gel-coupled by refractive index-matching optical gel to the fluorescence objective lens (1.2 NA) for optimal collection efficiency	Same	Same
Fluidics	FACSLyric Flow Cytometer fluidics - Uses FACSFlow as the sheath fluid Uses 10% bleach solution for system cleaning	Same	FACSLyric Flow Cytometer fluidics Same FACSDuet fluidics –Saline: used for washing the specimen probeDI water: used for washing the reagent and specimen probes10% bleach solution: used for cleaning the specimen probe during the FACSDuet End of Day Clean task
Software	FACSuite Clinical software	Modified FACSuite Clinical software(same software as FACSLyric with FACSDuet)	Modified FACSuite Clinical software FACSDuet software
Feature/Attribute	Predicate DeviceFACSLyric Flow Cytometer(K170974)	Subject Device/Modified DeviceFACSLyric Flow Cytometer	Subject Device/Modified DeviceFACSLyric Flow Cytometer with theintegrated FACSDuet SamplePreparation System
Firmware	CMS firmware	Modified CMS Firmware (same firmwareas FACSLyric with FACSDuet)	Modified CMS Firmware FACSDuet firmware
Loader	FACS Universal Loader	Modified FACS Universal Loader.Changes are listed below:Updated shaker to have a morerobust mechanism for thegripper fingers which hold onto the sample carrier; Modification to the door lockand sensor connections toenable automated transfer ofsample carriers fromFACSDuet to FACSLyric	Modified FACS Universal Loader.Changes are listed below:Updated shaker to have a morerobust mechanism for thegripper fingers which hold on tothe sample carrier; Modification to the door lockand sensor connections to enableautomated transfer of samplecarriers from FACSDuet toFACSLyric; Replacement of the loaderoutside cover (skins) andwindow, including relocation ofloader label and status light (forphysical integration only); Addition of a stabilizationbracket connecting FACSUniversal Loader to FACSDuetinstrument (for physicalintegration only.)
ResultsReporting	Software-assisted report generation	Same	Same
Feature/Attribute	Predicate DeviceFACSLyric Flow Cytometer(K170974)	Subject Device/Modified DeviceFACSLyric Flow Cytometer	Subject Device/Modified DeviceFACSLyric Flow Cytometer with theintegrated FACSDuet SamplePreparation System
SampleIntroduction	Manual loading onto the tube port ofthe flow cytometer Automated loading through a multi-tube FACS Universal Loader	Same	FACSLyric flow cytometer is not physicallyintegrated with FACSDuet SamplePreparation System:SameFACSLyric flow cytometer is physicalintegrated with FACSDuet SamplePreparation System:Same, plus FACSDuet instrumentautomatically transferring the 30 or 40-tube sample carrier to the modifiedFACS Universal Loader of FACSLyricflow cytometer
SamplePreparation	Manual	Same	Automated with FACSDuet SamplePreparation System
Pipetting	Manual Sample Preparation:Reverse pipetting for peripheral blood	Same	Automated Sample Preparation
Specimen TubeMixing	Manual Sample Preparation:Mixing manually	Same	Automated Sample Preparation
Sample TubeMixing	Manual Sample Preparation:Mixing manually	Same	Automated Sample Preparation
Incubation Time	Manual Sample Preparation:15 minutes	Same	15 minutes – 30 minutes
Feature/Attribute	Predicate DeviceFACSLyric Flow Cytometer(K170974)	Subject Device/Modified DeviceFACSLyric Flow Cytometer	Subject Device/Modified DeviceFACSLyric Flow Cytometer with theintegrated FACSDuet SamplePreparation System
Dimensions	Cytometer (W x D x H)63.3 x 57.9 x 57.9 cm(24.93 x 22.8 x 22.8 in)	Same	Cytometer with FACSDuet instrumentincluding FACSLyric workstation (W xD x H)282.9 x 77.1 x 85.0 cm(111.4 x 30.4 x 33.5 in)
Quality Control and Setup Beads
IntendedUse/Indicationsfor Use	BD FC beads 7-color kitThe BD FC beads 7-color kit (BD FCbeads), in conjunction with BD FACSuiteClinical software and BD CS&T beads,are used to establish fluorescencecompensation for the BD FACSLyricflow cytometer.	BD FC beads 7-color kitSame with minor correction.The BD FC beads 7-color kit (BD FCbeads), in conjunction with BD FACSuiteClinical software and BD CS&T beads, isused to establish fluorescencecompensation for the BD FACSLyricflow cytometer.	BD FC beads 7-color kitSame with minor correction.The BD FC beads 7-color kit (BD FCbeads), in conjunction with BD FACSuiteClinical software and BD CS&T beads, isused to establish fluorescence compensationfor the BD FACSLyric flow cytometer.
	BD CS&T beadsBD CS&T beads, in conjunction with BDFACSuite Clinical software, provide astandardized method for the qualitycontrol of optics, electronics, and fluidics,and for adjusting detector voltages andfluorescence compensation on the BDFACSLyric flow cytometer.	BD CS&T beadsSame	BD CS&T beadsSame

Table 2. Comparison Between Predicate Device and Subject Devices

BD Biosciences 510(k)

BD FACSLyric™ Flow Cytometer

BD FACSLyric™ Flow Cytometer with the integrated BD FACSDuet™ Sample Preparation System

Page 4 of 14

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BD FACSLyric™ Flow Cytometer
BD FACSLyric™ Flow Cytometer with the integrated BD FACSDuet™ Sample Preparation System

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Feature/Attribute	Predicate DeviceFACSLyric Flow Cytometer(K170974)	Subject Device/Modified DeviceFACSLyric Flow Cytometer	Subject Device/Modified DeviceFACSLyric Flow Cytometer with theintegrated FACSDuet SamplePreparation System
Quality Control& InstrumentSetup	Daily QC performed using CS&T beads. QC is also preformed every 6 months using CS&T beads. It includes all of the measurements performed in daily QC along with additional more detailed measurements and an automatic laser alignment. Daily instrument setup using CS&T beads. FC Beads are run every 2 months to measure and reset instrument spectral overlap values as part of the instrument setup.	Same	FACSLyric flow cytometer:Same FACSDuet instrument:- Initialization- Verification of dispense accuracy and precision- Process controls: Multi-Check Control and Multi-Check CD4 Low Control

The modified devices are the same as the predicate device as follows:

· The intended/indications for use, fundamental scientific technology, acquisition and analysis on FACSLyric flow cytometer system
· The intended/indications for use of the CS&T and FC 7-Color beads and the Quality Control and Instrument Setup on FACSLyric flow cytometer
· Sample preparation steps

The modified devices differ from the predicate device as follows:

· Adds an accessory, FACSDuet instrument, to automate sample preparation and transfer to FACSLyric flow cytometer for acquisition (applicable to the subject device FACSLyric with the integrated FACSDuet system only)

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· Minor changes to the CMS firmware, FACS Universal Loader hardware and FACSuite Clinical software to allow for the integration with FACSDuet instrument.

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8. Performance Data

8.1 Performance of Modified FACSLyric Flow Cytometer

From the predicate FACSLyric flow cytometer to the modified FACSLyric flow cytometer (subject device), system verification and validation testing was conducted to demonstrate the equivalent performance between the upgraded and previous released product.

8.2 Performance of FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation System

The following analytical (Table 3) and clinical (Table 4) performance data were provided to support the determination of substantial equivalency between the FACSLyric with the integrated FACSDuet system (subject device) and the FACSLyric flow cytometer (predicate device).

Study	Standard	Objective	Results
Within-site Precision	CLSI EP05-A3	To evaluate the within-site precision performance ofFACSLyric flow cytometer with FACSDuet instrument.	All acceptance criteria were met.
Whole BloodRepeatability	CLSI EP05-A3	To verify repeatability performance of FACSLyric flowcytometer with FACSDuet instrument using HIV+ patientand normal whole blood specimens.	Repeatability performance was demonstratedacross all the instruments.
Linearity	CLSI EP6-A	To evaluate the linear range of FACSLyric flowcytometer with FACSDuet instrument.	The linear range of FACSLyric flowcytometer with FACSDuet instrument wasestablished based on the acceptance criteria.
Limit of Blank (LoB) andLimit of Detection (LoD)	CLSI EP17-A2	To evaluate the LoB and LoD of FACSLyric flowcytometer with FACSDuet instrument.	LoB and LoD of FACSLyric flow cytometerwith FACSDuet instrument were established,and met the acceptance criteria.
Limit of Quantitation(LoQ)	CLSI EP17-A2	To evaluate the LoQ of FACSLyric flow cytometer withFACSDuet instrument.	LoQ of the FACSLyric flow cytometer withthe FACSDuet instrument was established,and met the acceptance criteria.

Table 3. Analytical Performance Summary

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Study	Standard	Objective	Results
In-Use Reagent StabilityPerformance	CLSI EP25-A	To evaluate the in-use reagent stability of the Multitest 6-Color TBNK in the FACSDuet instrument.	All acceptance criteria were met.
Equivalency between 15and 30 minutesIncubation Time	N/A	To demonstrate equivalency between 15 and 30 minutesstaining incubation time using manual and FACSDuetsample preparation.	All acceptance criteria were met.
Specimen Carryover	CLSI H26-A2	To evaluate the specimen to specimen and bleach tospecimen carryover in FACSDuet instrument	All acceptance criteria were met.
Reagent Carryover	N/A	To evaluate the reagent carryover in FACSDuetinstrument.	All acceptance criteria were met.
Pipette DispenseAccuracy and Precision	N/A	To evaluate the dispense accuracy and precisionperformance of FACSDuet instrument	All acceptance criteria were met.

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

		Table 4. Clinical Performance Summary
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Study	Standard	Testing Approach	Results
Method Comparison	CLSI EP09c	To evaluate performance equivalency between FACSLyric flowcytometer with FACSDuet instrument (subject device), andFACSLyric flow cytometer with manual sample preparation(predicate device).	A total of 399 enrolled specimens were testedacross 3 sites. 29 samples were non-evaluable.The acceptance criteria were met.
Inter-laboratoryReproducibility	CLSI EP05-A3	To evaluate inter-laboratory reproducibility for FACSLyric flowcytometer with FACSDuet instrument.	The results demonstrated that the variabilityacross three sites, and results met the acceptancecriteria.

9. Conclusion

The subject/modified devices, BD FACSLyric™ Flow Cytometer and BD FACSLyric™ Flow Cytometer with the integrated BD FACSDuet™ Sample Preparation System, demonstrate substantial equivalency to the predicate device, BD FACSLyric™ Flow Cytometer.

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.”