BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK

K170974 · Becton, Dickinson and Company · OYE · Jul 3, 2017 · Hematology

Device Facts

• Record ID: K170974
• Device Name: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
• Applicant: Becton, Dickinson and Company
• Product Code: OYE · Hematology
• Decision Date: Jul 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended 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. BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4, and BD Multitest™ CD3/CD16+CD56/CD45/CD19, all with optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets: BD Multitest 6-color TBNK with optional BD Trucount tubes - T lymphocytes (CD3+) - B lymphocytes (CD19+) - Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+) - Helper/inducer T lymphocytes (CD3+CD4+) - Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest IMK kit with optional BD Trucount tubes - T lymphocytes (CD3+) - B lymphocytes (CD19+) - Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+) - Helper/inducer T lymphocytes (CD3+CD4+) - Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes - T lymphocytes (CD3+) - Suppressor/cytotoxic T lymphocytes (CD3+CD8+) - Helper/inducer T lymphocytes (CD3+CD4+) BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes - T lymphocytes (CD3+) - Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+) - B lymphocytes (CD3-CD19+)

Device Story

Flow cytometer system (3-1, 4-2, 4-2-2, 4-3-3 configurations) for clinical immunophenotyping. Inputs: whole blood samples stained with IVD reagents. Operation: fluidics, optics (488nm/640nm lasers), and electronics measure light scatter and fluorescence as cells pass through a cuvette. Software performs automated gating of cellular populations with manual user adjustment. Output: absolute counts and percentages of lymphocyte subsets. Used in clinical laboratories by trained personnel. Benefits: standardized, automated identification and enumeration of lymphocyte subsets for immunological assessment.

Clinical Evidence

Clinical performance evaluated via method comparison study with 332-368 specimens across 5 clinical sites. Compared FACSLyric to FACSCanto II for lymphocyte subset enumeration. Results met acceptance criteria for all subsets; minimal bias observed. Inter-laboratory reproducibility evaluated at 4 sites using process control material. Reference intervals established for normal adult cohort (n=136). Bench testing included intra/inter-instrument configuration equivalency, precision (CLSI EP05-A3), linearity (CLSI EP6-A), carryover (CLSI H26-A2), and detection capability (CLSI EP17-A2). All bench and clinical performance metrics met pre-defined specifications.

Technological Characteristics

Flow cytometer with 488nm/640nm lasers; reflective optics with bandpass filters; gel-coupled cuvette flow cell. Dimensions: 22.8 x 24.93 x 22.8 inches. Vacuum-driven fluidics. Automated sample loading via Universal Loader. Software: BD FACSuite Clinical. Electronics: two PCBAs for analog-to-digital conversion. Connectivity: data transmission to workstation.

Indications for Use

Indicated for immunophenotyping of peripheral whole blood in normal individuals and patients with suspected or confirmed immune deficiency. Used to determine percentages and absolute counts of mature human lymphocyte subsets (T, B, NK, helper/inducer T, suppressor/cytotoxic T).

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• BD FACSCanto II system (K141468, K062087)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a series of human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 28, 2017

Becton, Dickinson and Company Li Zhou Manager, Regulatory Affairs, BD Biosciences 2350 Qume Drive San Jose. CA 95131

Re: K170974

Trade/Device Name: BD FACSLyric™ Flow Cytometer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: OYE Dated: March 31, 2017 Received: April 03, 2017

Dear Ms. Zhou:

This letter corrects our substantially equivalent letter of July 3, 2017.

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Leonthena R. Carrington -S

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

Enclosure

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### Indications for Use

510(k) Number (if known) K170974

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.

BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4, and BD Multitest™ CD3/CD16+CD56/CD45/CD19, all with optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets:

BD Multitest 6-color TBNK with optional BD Trucount tubes

- · T lymphocytes (CD3+)
- · B lymphocytes (CD19+)
- · Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+)
- · Helper/inducer T lymphocytes (CD3+CD4+)
- · Suppressor/cytotoxic T lymphocytes (CD3+CD8+)

BD Multitest IMK kit with optional BD Trucount tubes

- · T lymphocytes (CD3+)
- · B lymphocytes (CD19+)
- · Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+)
- · Helper/inducer T lymphocytes (CD3+CD4+)
- · Suppressor/cytotoxic T lymphocytes (CD3+CD8+)

BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes

- · T lymphocytes (CD3+)
- · Suppressor/cytotoxic T lymphocytes (CD3+CD8+)
- · Helper/inducer T lymphocytes (CD3+CD4+)

BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes

- · T lymphocytes (CD3+)
- · Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+)
- · B lymphocytes (CD3-CD19+)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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#### Section 5 510(k) Summary

This bundled 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: March 31, 2017

#### 5.1 Submitted By

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

| Contact: | Li Zhou<br>Manager, Regulatory Affairs |
|------------|----------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

#### 5.2 Device

Trade Name/Device Name: BD FACSLyric™ 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

#### 5.3 Predicate Device

The predicate device is BD FACSCanto™ II system with BD Multitest™ reagents that consists of the following:

- FACSCanto II flow cytometer (4-2, 4-2-2 and 5-3 optical configurations) (K141468 ● and K062087)
- . FACSCanto Clinical Software (Multitest 6-Color and 4-Color assays are included as panels within FACSCanto Clinical software) (K141468 and K062087)
- FACS 7-Color Setup Beads (K040026) ●
- Multitest 6-Color TBNK (K090967)
- Multitest IMK Kit (K980858)
- Multitest CD3/CD8/CD45/CD4 (K974360)
- Multitest CD3/C16+CD56/CD45/CD19 (K980858)
- Multi-Check Control (K961610) ●
- Multi-Check CD4 Low Control (K982231) ●
- Trucount Tubes (K970836)
- Optional FACS Loader (K141468 and K062087)

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#### 5.4 Device Description

The BD FACSLyric Flow Cytometer consists of the following components.

- FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations) ●
- FACSuite Clinical Software ●
- Multitest 6-Color Assay Modules ●
- Multitest 4-Color Assay Modules ●
- FC Beads 7-Color Kit
- CS&T Beads
- Multitest 6-Color TBNK
- Multitest IMK Kit
- . Multitest CD3/CD8/CD45/CD4
- Multitest CD3/CD16+CD56/CD45/CD19 ●
- . Multi-Check Control
- . Multi-Check CD4 Low Control
- . Trucount Tubes
- Optional FACS Universal Loader ●

In accordance with FDA Guidance for Industry and FDA Staff, Bundling Multiple Devices or Multiple Indications in a Single Submission, dated June 22, 2007, four Multitest assays with the instrument, beads and process controls are bundled within this submission.

The FACSLyric System with Multitest Reagents is intended for the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency using flow cytometry applications.

The system is an immunofluorescence assay system for identification and enumeration of lymphocyte subsets in peripheral whole blood. When blood is added to the monoclonal antibody reagent, the fluorochrome-labeled antibodies in the reagent bind specifically to lymphocvte surface antigens. During acquisition, the cells travel past one or more laser beams in a single file and scatter the laser light. The stained cells fluoresce. The scatter and fluorescence light is detected by the flow cytometer, separated by dichroic mirrors and optical filters, and then quantified with photomultiplier tubes (PMTs) to determine the percent lymphocyte of particular cell populations.

Multiple monoclonal antibodies each labeled with a different fluorochrome are contained within one reagent tube to simultaneously identify multiple lymphocyte subset populations. The use of Trucount tubes provides the absolute number of the fluorochrome-labeled antibody bound cells.

The FACSLyric System with Multitest Reagents is intended for Prescription Use Only and will be labeled "Rx Only".

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#### 5.5 Indications for Use

### 5.6.1 BD FACSLvric Flow Cytometer

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.

BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4. and BD Multitest™ CD3/CD16+CD56/CD45/CD19. all with optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets:

BD Multitest 6-color TBNK with optional BD Trucount tubes

- T lymphocytes (CD3+) ●
- B lymphocytes (CD19*) .
- . Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56*)
- . Helper/inducer T lymphocytes (CD3*CD4*)
- Suppressor/cytotoxic T lymphocytes (CD3*CD8*)

BD Multitest IMK kit with optional BD Trucount tubes

- T lymphocytes (CD3+) .
- . B lymphocytes (CD19*)
- Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56*)
- Helper/inducer T lymphocytes (CD3+CD4*) .
- Suppressor/cytotoxic T lymphocytes (CD3*CD8*) .

BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes

- T lymphocytes (CD3+)
- Suppressor/cytotoxic T lymphocytes (CD3+CD8+) .
- . Helper/inducer T lymphocytes (CD3+CD4+)

### BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes

- T lymphocytes (CD3+) ●
- Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+)
- B lymphocytes (CD3-CD19+) .

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### 5.6.2 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.

### 5.6.3 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 for adjusting detector voltages and fluorescence compensation on the BD FACSLyric™ flow cytometer.

#### BD Multitest 6-color TBNK 5.6.4

BD Multitest™ 6-color TBNK with optional BD Trucount™ tubes is intended for use with BD FACSLyric™, BD FACSCanto™ II, and BD FACSCanto™ flow cytometers to determine the percentages and absolute counts of the following mature human lymphocyte subsets in peripheral whole blood for immunophenotyping:

- T lymphocytes (CD3+) ●
- . B lymphocytes (CD19*)
- Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56*)
- Helper/inducer T lymphocytes (CD3+CD4+)
- Suppressor/cytotoxic T lymphocytes (CD3*CD8*) ●

This reagent is indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency.

#### BD Multitest IMK Kit 5.6.5

BD Multitest™ IMK kit with optional BD Trucount™ tubes is intended for use with BD FACSLyric™, BD FACSCanto™ II, BD FACSCanto™ , and BD FACSCalibur™ flow cytometers to determine the percentages and absolute counts of the following mature human lymphocyte subsets in peripheral whole blood for immunophenotyping:

- T lymphocytes (CD3+) .
- B lymphocytes (CD19+) ●
- Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+)
- . Helper/inducer T lymphocytes (CD3+CD4+)
- Suppressor/cytotoxic T lymphocytes (CD3+CD8+) ●

This reagent is indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency.

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### 5.6.6 BD Multitest CD3/CD8/CD45/CD4

BD Multitest™ CD3/CD8/CD45/CD4 with optional BD Trucount™ tubes is intended for use with BD FACSLyric™, BD FACSCanto™ II, BD FACSCanto™, and BD FACSCalibur™ flow cytometers to determine the percentages and absolute counts of the following mature human lymphocyte subsets in peripheral whole blood for immunophenotyping:

- T lymphocytes (CD3+) ●
- . Helper/inducer T lymphocytes (CD3+CD4+)
- Suppressor/cvtotoxic T 1vmphocytes (CD3+CD8+) .

This reagent is indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency.

#### BD Multitest CD3/CD16+CD56/CD45/CD19 5.6.7

BD Multitest™ CD3/CD16+CD56/CD45/CD19 with optional BD Trucount™ tubes is intended for use with BD FACSLyric™, BD FACSCanto™ II, BD FACSCanto™, and BD FACSCalibur™ flow cytometers to determine the percentages and absolute counts of the following mature human lymphocyte subsets in peripheral whole blood for immunophenotyping:

- · T lymphocytes (CD3+)
- Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+) .
- B lymphocytes (CD3-CD19+) .

This reagent is indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency.

### 5.6.8 BD Multi-Check Control

BD™ Multi-Check Control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis on BD FACSLyric™, BD FACSCanto™ II, BD FACSCanto™, and BD FACSCalibur™ flow cvtometers.

### 5.6.9 BD Multi-Check CD4 Low Control

BD™ Multi-Check CD4 Low Control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis on BD FACSLyric™, BD FACSCanto™ II, BD FACSCanto™, and BD FACSCalibur™ flow cytometers.

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### 5.6.10 BD Trucount Tubes

BD Trucount™ tubes are intended for use with appropriated BD IVD reagent products on BD FACSLyric™, BD FACSVia™, BD FACSCanto™, BD FACSCanto™ II and BD FACSCalibur™ flow cytometers to determine absolute counts of leucocytes in erythrocyte-lysed whole blood.

#### 5.6 Comparison of Technological Characteristics with the Predicate Device

A comparison of the similarities and differences between the subject device and the predicate device is presented in Table 5-1 to Table 5-4

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| | Table 5-1 Classification and Methodology | | |
|--|------------------------------------------|--|--|
|--|------------------------------------------|--|--|

| Feature/Attribute | Subject Device | Predicate Device | |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device<br>Classification and<br>Product Code | Automated Differential Cell Counter Regulatory Class: II Regulation Number: 21 CFR 864.5220 Product Code: OYE | Same | |
| Assay<br>Methodology | Flow Cytometry | Same | |
| Detection/Assay<br>Principle | Immunofluorescence | Same | |
| Monoclonal<br>Antibody Reagents | Multitest 6-color TBNK Multitest IMK kit Multitest CD3/CD8/CD45/CD4 Multitest CD3/CD16 +CD56/CD45/CD19 All with optional Trucount tubes to provide identification and<br>enumeration of Total CD3+, CD3+CD4+, CD3+CD8+,<br>CD16+CD56+ and CD19+ percentages and absolute count<br>results | Same | |
| Specimen Type | Peripheral whole blood | Same | |
| Sample Volume | 50 µL | Same | |
| Sample<br>Preparation | Manual | Manual Automated (when used with optional accessory FACS<br>Sample Prep Assistant III ) | |
| Feature/Attribute | Subject Device | Predicate Device | |
| Intended Use/ | Flow Cytometer | | |
| Indications for<br>Use - Flow<br>Cytometer | The BD FACSLyric flow cytometer is intended for use as an in<br>vitro diagnostic device for immunophenotyping using up to six<br>fluorescence detection channels and two light scatter channels<br>using a blue (488-nm) and a red (640-nm) laser. It is intended for<br>use with in vitro diagnostic (IVD) assays and software that are<br>indicated for use with the instrument.<br>BD Multitest 6-color TBNK, BD Multitest IMK kit, BD Multitest<br>CD3/CD8/CD45/CD4, and BD Multitest<br>CD3/CD16+CD56/CD45/CD19, all with optional BD Trucount<br>tubes, are intended for use on the BD FACSLyric flow cytometer<br>with peripheral whole blood for immunophenotyping. These<br>reagents are indicated for use in the immunological assessment of<br>normal individuals, and patients having, or suspected of having,<br>immune deficiency. These reagents determine the percentages<br>and absolute counts of the following mature human lymphocyte<br>subsets:<br>BD Multitest 6-color TBNK with optional BD Trucount tubes<br>T lymphocytes (CD3+)<br>●<br>B lymphocytes (CD19+)<br>●<br>Natural killer (NK) lymphocytes (CD3-CD16+ and/or<br>●<br>CD56+)<br>Helper/inducer T lymphocytes (CD3+CD4+)<br>●<br>Suppressor/cytotoxic T lymphocytes (CD3+CD8+)<br>●<br>BD Multitest IMK kit with optional BD Trucount tubes<br>T lymphocytes (CD3+)<br>● | The BD FACSCanto II flow cytometers (4-2-2 and 5-3<br>configurations) function as part of a system with dedicated clinical<br>software intended for use with cleared or approved in vitro<br>diagnostic (IVD) assays that are indicated for use with the<br>instrument for the identification and enumeration of human cell<br>subsets. Only six detection channels using a blue (488 nm) and a<br>red (633 nm) laser have been cleared for in vitro diagnostic use. For<br>use with or without the BD FACS Sample Prep Assistant III.<br>The BD FACSCanto II flow cytometer (4-2 configuration) is<br>intended for use as an In Vitro Diagnostic device for identification<br>and enumeration of lymphocyte subsets in human cells in<br>suspension.<br>· Immunophenotyping in clinical laboratories, using previously<br>cleared in vitro diagnostic assays for flow cytometry.<br>· Identification and enumeration of lymphocyte subsets in human<br>cells in suspension.<br>· For in vitro diagnostic use.<br>· For use with or without the BD FACS Sample Prep Assistant III<br>See intended use for BD Multitest reagents in Table 5-4. | |
| | B lymphocytes (CD19+)<br>●<br>Natural killer (NK) lymphocytes (CD3-CD16+ and/or<br>●<br>CD56+)<br>Helper/inducer T lymphocytes (CD3+CD4+)<br>●<br>Suppressor/cytotoxic T lymphocytes (CD3+CD8+)<br>● | | |
| Feature/Attribute | Subject Device | Predicate Device | |
| | BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount<br>tubes | | |
| | • T lymphocytes (CD3+) | | |
| | • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) | | |
| | • Helper/inducer T lymphocytes (CD3+CD4+) | | |
| | BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD<br>Trucount tubes | | |
| | • T lymphocytes (CD3+) | | |
| | • Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+) | | |
| | • B lymphocytes (CD3-CD19+) | | |
| Maximum<br>Parameter<br>Detectors | IVD detection channels – Six Fluorescence channels plus forward scatter and side scatter | Same | |
| Forward Scatter<br>Detection | Photodiode with built-in 488/10 bandpass filter | Same | |
| Fluorescence and<br>Side Scatter<br>Detection | Side scatter and fluorescence<br>• Reflective optics with single transmission bandpass filter in front of each PMT<br>• High performance PMT modules for all fluorescence and side scatter channels<br>• Light collected by objective lens is delivered by fiber optics to specially designed detector arrays<br>• 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 | |
| Forward and Side<br>Scatter Sensitivity | Enables separation of fixed platelets from noise.…