(89 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the performance studies described are standard analytical and clinical validation studies for a flow cytometer, not indicative of AI/ML model training or evaluation.
No
The device is described as an in vitro diagnostic device for immunophenotyping, which is used for analysis and not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping."
No
The device description explicitly lists multiple hardware components including the flow cytometer, automated sample preparation system, universal loader, and various reagents and beads, indicating it is a system with significant hardware.
Yes, the provided text explicitly states that the BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device. This is mentioned multiple times in the "Intended Use / Indications for Use" section.
N/A
Intended Use / Indications for Use
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) 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.
Product codes
OYE
Device Description
The BD FACSLyric Flow Cytometer system components include:
- BD FACSLyric™ Flow Cytometer
- BD FACSTM Universal Loader
- BD FACSuite™ Clinical software
- BD FACSDuet™ Sample Preparation System (optional new instrument)
- BD Multitest™ 6- Color and 4-Color Assay Modules
- BD® FACSFlow™ Sheath Fluid
- BD® CS&T Beads
- BD® FC Beads 7-Color Kit
The modifications to the cleared FACSLyric flow cytometer include:
- 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.
- The addition of FACSDuet instrument as an optional automated sample preparation accessory to FACSLyric Flow Cytometer.
The FACSDuet instrument is an automated sample preparation instrument that is data integrated with the FACSLyric flow cytometer and may also be physically integrated. It is designed to be used with BD Multitest reagents for use on the FACSLyric flow cytometer. The system performs immunophenotyping using fluorescence detection channels and light scatter channels with blue (488-nm) and red (640-nm) lasers. It includes an automated system for preparing human peripheral whole blood samples for acquisition and analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Flow Cytometry / Immunofluorescence
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)
Performance of Modified FACSLyric Flow Cytometer:
- System verification and validation testing was conducted to demonstrate the equivalent performance between the upgraded and previous released product.
Performance of FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation System:
- Analytical Performance Studies:
- Within-site Precision (CLSI EP05-A3): To evaluate the within-site precision performance of FACSLyric flow cytometer with FACSDuet instrument. Results: All acceptance criteria were met.
- Whole Blood Repeatability (CLSI EP05-A3): To verify repeatability performance of FACSLyric flow cytometer with FACSDuet instrument using HIV+ patient and normal whole blood specimens. Results: Repeatability performance was demonstrated across all the instruments.
- Linearity (CLSI EP6-A): To evaluate the linear range of FACSLyric flow cytometer with FACSDuet instrument. Results: 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) (CLSI EP17-A2): To evaluate the LoB and LoD of FACSLyric flow cytometer with FACSDuet instrument. Results: LoB and LoD of FACSLyric flow cytometer with FACSDuet instrument were established, and met the acceptance criteria.
- Limit of Quantitation (LoQ) (CLSI EP17-A2): To evaluate the LoQ of FACSLyric flow cytometer with FACSDuet instrument. Results: LoQ of the FACSLyric flow cytometer with the FACSDuet instrument was established, and met the acceptance criteria.
- In-Use Reagent Stability Performance (CLSI EP25-A): To evaluate the in-use reagent stability of the Multitest 6-Color TBNK in the FACSDuet instrument. Results: All acceptance criteria were met.
- Equivalency between 15 and 30 minutes Incubation Time (N/A): To demonstrate equivalency between 15 and 30 minutes staining incubation time using manual and FACSDuet sample preparation. Results: All acceptance criteria were met.
- Specimen Carryover (CLSI H26-A2): To evaluate the specimen to specimen and bleach to specimen carryover in FACSDuet instrument. Results: All acceptance criteria were met.
- Reagent Carryover (N/A): To evaluate the reagent carryover in FACSDuet instrument. Results: All acceptance criteria were met.
- Pipette Dispense Accuracy and Precision (N/A): To evaluate the dispense accuracy and precision performance of FACSDuet instrument. Results: All acceptance criteria were met.
- Clinical Performance Studies:
- Method Comparison (CLSI EP09c): To evaluate performance equivalency between FACSLyric flow cytometer with FACSDuet instrument (subject device), and FACSLyric flow cytometer with manual sample preparation (predicate device). Results: A total of 399 enrolled specimens were tested across 3 sites. 29 samples were non-evaluable. The acceptance criteria were met.
- Inter-laboratory Reproducibility (CLSI EP05-A3): To evaluate inter-laboratory reproducibility for FACSLyric flow cytometer with FACSDuet instrument. Results: The results demonstrated that the variability across three sites, and results met the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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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
1
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
2
Indications for Use
510(k) Number (if known) K201814
Device Name BD FACSLyric™ Flow Cytometer
Indications for Use (Describe)
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.
| 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."
3
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)
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.
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."
4
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).
5
| System component | Cleared in
K170974 | Modification of this Special
510(k) |
|-----------------------------------------------------------------------------------------------|-----------------------|----------------------------------------|
| BD FACSLyric™ Flow Cytometer | Yes | Modified |
| BD FACSTM Universal Loader | Yes | Modified |
| BD FACSuite™ Clinical software | Yes | Modified |
| BD FACSDuet™ Sample Preparation
System (hereinafter referred to as
FACSDuet instrument) | No | Modified (new instrument) |
| BD Multitest™ 6- Color and 4-Color
Assay 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 Device
FACSLyric Flow Cytometer
(K170974) | Subject Device/Modified Device
FACSLyric Flow Cytometer | Subject Device/Modified Device
FACSLyric Flow Cytometer with the
integrated FACSDuet Sample
Preparation System |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Flow Cytometer System | |
| Device
Classification and
Product Code | Automated Differential Cell Counter
• Regulatory Class: II
• Regulation Number: 21 CFR 864.5220
• Product Code: OYE | Same | Same |
| Assay
Methodology | Flow Cytometry | Same | Same |
| Detection/Assay
Principle | Immunofluorescence | Same | Same |
| Intended
Use/Indications
for Use | 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. | Same | The BD FACSLyricTM flow cytometer with
the integrated BD FACSDuetTM 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. |
| Specimen Type | Peripheral whole blood | Same | Same |
| Sample Volume | 50 µL | Same | Same |
| Feature/Attribute | Predicate Device
FACSLyric Flow Cytometer
(K170974) | Subject Device/Modified Device
FACSLyric Flow Cytometer | Subject Device/Modified Device
FACSLyric Flow Cytometer with the
integrated FACSDuet Sample
Preparation System |
| Optical
Configurations | • 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 using
red 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 |
| Maximum
Parameter
Detectors | IVD detection channels – Six
Fluorescence channels plus forward
scatter and side scatter | Same | Same |
| IVD
Lasers/Excitation | Blue Laser:
• Wavelength: 488 nm
• Optical power: 20mW
Red Laser:
• Wavelength: 640 nm
• Optical power: 40 mW | Same | Same |
| Electronics | Up to 35000 events, sec | Same | Same |
| Forward Scatter
Detection | Photodiode with built in 488/10 bandpass
filter | Same | Same |
| Feature/Attribute | Predicate Device
FACSLyric Flow Cytometer
(K170974) | Subject Device/Modified Device
FACSLyric Flow Cytometer | Subject Device/Modified Device
FACSLyric Flow Cytometer with the
integrated FACSDuet Sample
Preparation System |
| Fluorescence and
Side Scatter
Detection | 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 probe
DI water: used for washing the reagent and specimen probes
10% 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 Device
FACSLyric Flow Cytometer
(K170974) | Subject Device/Modified Device
FACSLyric Flow Cytometer | Subject Device/Modified Device
FACSLyric Flow Cytometer with the
integrated FACSDuet Sample
Preparation System |
| Firmware | CMS firmware | Modified CMS Firmware (same firmware
as 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 more
robust mechanism for the
gripper fingers which hold on
to the sample carrier; Modification to the door lock
and sensor connections to
enable automated transfer of
sample carriers from
FACSDuet to FACSLyric | Modified FACS Universal Loader.
Changes are listed below:
Updated shaker to have a more
robust mechanism for the
gripper fingers which hold on to
the sample carrier; Modification to the door lock
and sensor connections to enable
automated transfer of sample
carriers from FACSDuet to
FACSLyric; Replacement of the loader
outside cover (skins) and
window, including relocation of
loader label and status light (for
physical integration only); Addition of a stabilization
bracket connecting FACS
Universal Loader to FACSDuet
instrument (for physical
integration only.) |
| Results
Reporting | Software-assisted report generation | Same | Same |
| Feature/Attribute | Predicate Device
FACSLyric Flow Cytometer
(K170974) | Subject Device/Modified Device
FACSLyric Flow Cytometer | Subject Device/Modified Device
FACSLyric Flow Cytometer with the
integrated FACSDuet Sample
Preparation System |
| Sample
Introduction | Manual loading onto the tube port of
the flow cytometer Automated loading through a multi-
tube FACS Universal Loader | Same | FACSLyric flow cytometer is not physically
integrated with FACSDuet Sample
Preparation System:
Same
FACSLyric flow cytometer is physical
integrated with FACSDuet Sample
Preparation System:
Same, plus FACSDuet instrument
automatically transferring the 30 or 40-
tube sample carrier to the modified
FACS Universal Loader of FACSLyric
flow cytometer |
| Sample
Preparation | Manual | Same | Automated with FACSDuet Sample
Preparation System |
| Pipetting | Manual Sample Preparation:
Reverse pipetting for peripheral blood | Same | Automated Sample Preparation |
| Specimen Tube
Mixing | Manual Sample Preparation:
Mixing manually | Same | Automated Sample Preparation |
| Sample Tube
Mixing | Manual Sample Preparation:
Mixing manually | Same | Automated Sample Preparation |
| Incubation Time | Manual Sample Preparation:
15 minutes | Same | 15 minutes – 30 minutes |
| Feature/Attribute | Predicate Device
FACSLyric Flow Cytometer
(K170974) | Subject Device/Modified Device
FACSLyric Flow Cytometer | Subject Device/Modified Device
FACSLyric Flow Cytometer with the
integrated FACSDuet Sample
Preparation 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 instrument
including FACSLyric workstation (W x
D 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 | | | |
| Intended
Use/Indications
for Use | BD FC beads 7-color kit
The BD FC beads 7-color kit (BD FC
beads), in conjunction with BD FACSuite
Clinical software and BD CS&T beads,
are used to establish fluorescence
compensation for the BD FACSLyric
flow cytometer. | BD FC beads 7-color kit
Same with minor correction.
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. | BD FC beads 7-color kit
Same with minor correction.
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. |
| | BD CS&T beads
BD CS&T beads, in conjunction with BD
FACSuite Clinical software, provide a
standardized method for the quality
control of optics, electronics, and fluidics,
and for adjusting detector voltages and
fluorescence compensation on the BD
FACSLyric flow cytometer. | BD CS&T beads
Same | BD CS&T beads
Same |
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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9
BD FACSLyric™ Flow Cytometer
BD FACSLyric™ Flow Cytometer with the integrated BD FACSDuet™ Sample Preparation System
10
11
12
13
| Feature/Attribute | Predicate Device
FACSLyric Flow Cytometer
(K170974) | Subject Device/Modified Device
FACSLyric Flow Cytometer | Subject Device/Modified Device
FACSLyric Flow Cytometer with the
integrated FACSDuet Sample
Preparation System |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Quality Control
& Instrument
Setup | 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)
14
- · Minor changes to the CMS firmware, FACS Universal Loader hardware and FACSuite Clinical software to allow for the integration with FACSDuet instrument.
15
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 of | |
| FACSLyric flow cytometer with FACSDuet instrument. | All acceptance criteria were met. | ||
| Whole Blood | |||
| Repeatability | CLSI EP05-A3 | 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 | CLSI EP6-A | 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) | CLSI EP17-A2 | 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) | CLSI EP17-A2 | 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. |
Table 3. Analytical Performance Summary
16
| Study | Standard | Objective | Results |
|---|---|---|---|
| In-Use Reagent Stability | |||
| Performance | 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 15 | |||
| and 30 minutes | |||
| Incubation Time | N/A | To demonstrate equivalency between 15 and 30 minutes | |
| staining incubation time using manual and FACSDuet | |||
| sample preparation. | All acceptance criteria were met. | ||
| Specimen Carryover | CLSI H26-A2 | To evaluate the specimen to specimen and bleach to | |
| specimen carryover in FACSDuet instrument | All acceptance criteria were met. | ||
| Reagent Carryover | N/A | To evaluate the reagent carryover in FACSDuet | |
| instrument. | All acceptance criteria were met. | ||
| Pipette Dispense | |||
| Accuracy and Precision | N/A | To evaluate the dispense accuracy and precision | |
| performance of FACSDuet instrument | All acceptance criteria were met. |
17
| Table 4. Clinical Performance Summary | |||
|---|---|---|---|
| -- | -- | --------------------------------------- | -- |
| Study | Standard | Testing Approach | Results |
|---|---|---|---|
| Method Comparison | CLSI EP09c | 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 | CLSI EP05-A3 | 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. |
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.