AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS

K141932 · Beckman Coulter, Inc. · OYE · Apr 10, 2015 · Hematology

Device Facts

• Record ID: K141932
• Device Name: AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
• Applicant: Beckman Coulter, Inc.
• Product Code: OYE · Hematology
• Decision Date: Apr 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV). It is used in conjunction with the following reagents and software package. AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of; AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent · Total CD3+, CD3+CD4+,CD3+CD3+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts. · CD45+ absolute count · CD45+ Low SS (lymphocytes) percentage and absolute count AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts. · CD45+ absolute count · CD45+ Low SS (lymphocytes) percentage and absolute count AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with the monoclonal antibody reagents listed above. The off-line analysis must be performed in accordance with the product labeling.

Device Story

AQUIOS CL Flow Cytometry System performs automated immunophenotyping of peripheral whole blood. Input: whole blood samples loaded via autoloader or single-tube; reagents (Tetra-1/Tetra-2+ panels, lysing kit). Operation: on-board sample preparation (automated lysing/quenching); cells pass through 488 nm blue laser; system measures fluorescence, light scatter, and electronic volume. Software performs automated gating and analysis to identify/enumerate lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, CD56+/CD16+). Output: absolute counts and percentages of lymphocyte populations. Used in clinical laboratories by trained personnel. Results assist clinicians in assessing immune status. System includes optional offline workstation for data review. Benefits: standardized, rapid, no-wash sample processing; reduced manual intervention; improved laboratory reproducibility.

Clinical Evidence

Bench testing only. Studies included fluorescence and electronic volume linearity, laser stability, carryover, precision (repeatability and long-term imprecision), method comparison against predicates, and reference interval establishment. All performance metrics met pre-defined acceptance criteria.

Technological Characteristics

Flow cytometer with 488 nm solid-state laser. Detectors: FS diode, SS solid-state, 4 fluorescence channels (FL1-FL4). Volumetric metering (Coulter Principle). Automated on-board sample preparation. Connectivity: Integrated touch-screen computer, LIS reporting. Software: AQUIOS System Software (Windows 7). Sterilization: N/A (reagents are IVD).

Indications for Use

Indicated for immunologic assessment of patients having, or suspected of having, immune deficiency. Used with peripheral whole blood for immunophenotyping.

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

• CaliBRITE 3 Color and FACSComp (k961623)
• CaliBRITE APC beads CaliBRITE 4 kit (k973483)
• MultiTEST CD3/CD8/CD45/CD4 (k974360)
• Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest IMK Kit Lysing Solution with BD TruCount Tubes (k980858)
• Immuno-Trol Control Cells (k984216)
• Immuno-Trol Low Cells (k013842)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted in profile, with its head facing right, and its feathers are represented by a series of curved lines.

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

January 27, 2016

Beckman Coulter, Inc. c/o Mr. Anthony Dennis Staff Regulatory Affairs Specialist 11800 SW 147th Avenue, M/S 31-B06 Miami, FL 33196-2500

Re: K141932

Trade/Device Name: AQUIOS CL Flow Cytometry System AQUIOS Tetra-1 and Tetra-2+ Monoclonal Antibody Reagents AQUIOS Lysing Reagent Kit AQUIOS Immuno-Trol and Immuno-Trol Low Cells Regulation Number: 21 CFR §864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: OYE, JPK, GGK Dated: March 5, 2015 Received: March 9, 2015

Dear Mr. Dennis:

This letter corrects our substantially equivalent letter of April 10, 2015.

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.

{1}------------------------------------------------

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 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 you desire specific advice for your device on our labeling regulation (21 CFR Parts 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/Resourcesfor You/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 yours,

# Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known) k141932

Device Name AQUIOS CL Flow Cytometry System

#### Indications for Use (Describe)

The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 mm) laser, two light scatter detection volume (EV). It is used in conjunction with the following reagents and software package.

AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;

- AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent

· Total CD3+, CD3+CD4+,CD3+CD3+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts.

• CD45+ absolute count

- · CD45+ Low SS (lymphocytes) percentage and absolute count
AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent

- · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
- CD45+ absolute count
- · CD45+ Low SS (lymphocytes) percentage and absolute count

AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with the monoclonal antibody reagents listed above. The off-line analysis must be performed in accordance with the product labeling.

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

| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|--------------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

#### 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 [e-mail]

{3}------------------------------------------------

510(k) Number (if known) k141932

Device Name

AQUIOS Tetra-1 and Tetra-2+ Monoclonal Antibody Reagents

Indications for Use (Describe)

AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;

- AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent

· Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+(ratio only) lymphocyte percentages and absolute

counts.

- CD45+ absolute count
- · CD45+ Low SS (lymphocytes) percentage and absolute count
- AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent
- · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
- CD45+ absolute count
- · CD45+ Low SS (lymphocytes) percentage and absolute count

| 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)

#### 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 [e-mail]

{4}------------------------------------------------

510(k) Number (if known) k141932

Device Name AQUIOS Lysing Reagent Kit

#### Indications for Use (Describe)

AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells. Type of

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> × Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### 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 [e-mail]

{5}------------------------------------------------

510(k) Number (if known) k141932

Device Name

AQUIOS Immuno-Trol and Immuno-Trol Low Cells

Indications for Use (Describe)

AQUIOS IMMUNO-TROL Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.

AQUIOS IMMUNO-TROL Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.

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

| <div> <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

#### 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 [e-mail]

{6}------------------------------------------------

## 510(k) Summary for AQUIOS CL Flow Cytometry System

#### 510(k) Owner / Submitter Information

Name: Beckman Coulter Inc. Address: 11800 SW 147th Ave., Miami, FL 33196 Phone #: [phone] Fax #: [phone] Contact Person: Anthony Dennis Email Address: [e-mail] Date Updated: April 9, 2015

#### Device Information

Trade Name: AOUIOS CL Flow Cytometry System Common Name: AQUIOS CL Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: OYE Panel: Hematology

Trade Name: AQUIOS Tetra-1 and Tetra-2+ Monoclonal Antibody Reagents Common Name: AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: OYE Panel: Hematology

#### Trade Name: AOUIOS Lysing Reagent Kit

Common Name: AQUIOS Lysing Reagent Kit Classification Name: Red cell lysing reagent (21 CFR 864.8540), Automated differential cell counter (21 CFR 864.5220) Classification: Class I Non-Exempt [due to limitations of the exemptions of 21 CFR 864.9(c)(1) and (c)(3)] Product Code: GGK, OYE [as used as part of the AQUIOS flow cytometry system] Panel: Hematology

Trade Name: AOUIOS Immuno-Trol and Immuno-Trol Low Cells Common Name: AOUIOS Immuno-Trol and Immuno-Trol Low Classification Name: Hematology quality control mixture (21 CFR 864.8625) Classification: Class II Product Code: JPK Panel: Hematology

{7}------------------------------------------------

### Predicate Device Information

| Predicate Product | 510(k)<br>Number | Date<br>Cleared | Classification | 21 CFR | Product<br>Code |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------------|----------------|----------|-----------------|
| CaliBRITE 3 Color and<br>FACSComp | K961623 | 6/07/96 | Class II | 864.5220 | GKZ |
| CaliBRITE APC beads CaliBRITE<br>4 kit (unlabeled, FITC-, PE-,<br>PerCP- and APC- labeled<br>CaliBRITE beads), and<br>FACSComp software<br>(FACSCalibur) | K973483 | 2/17/98 | Class II | 864.5220 | GKZ |
| MultiTEST CD3/CD8/CD45/CD4 | K974360 | 03/11/98 | Class II | 864.5220 | GKZ |
| Multitest<br>CD3/CD16+56/CD45/CD19<br>Reagent and Multitest IMK Kit<br>Lysing Solution with BD TruCount<br>Tubes | K980858 | 5/22/98 | Class II | 864.5220 | GKZ |
| Unicel DxH 800 | K140911 | 09/05/14 | Class II | 864.5220 | GKZ |
| Immuno-Trol Control Cells | K984216 | 03/16/99 | Class II | 864.8625 | JPK |
| Immuno-Trol Low Cells | K013842 | 12/13/01 | Class II | 864.8625 | JPK |

#### Device Description

The AQUIOS CL Flow Cytometry System is composed of the following components:

- . AQUIOS CL Flow Cytometer
- AQUIOS System Software ●
- AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 ●
- AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 ●
- AQUIOS Immuno-Trol Cells ●
- AQUIOS Immuno-Trol Low Cells ●
- . AQUIOS Lysing Reagent Kit

The AQUIOS CL Flow Cytometer uses flow cytometric principles to determine qualitative and quantitative measurements of biological and physical properties of cells

{8}------------------------------------------------

and other particles. These properties are measured when the cells pass through the laser beam(s) in single file.

The AQUIOS System Software is designed for the AQUIOS CL flow cytometer. It includes the algorithms and test definitions that provide automated analysis and results for AQUIOS Tetra-1 and 2+ reagents; this application cannot be modified by the user.

The AQUIOS Flow Cytometry System also offers an optional standalone offline workstation. This workstation is identical to the workstation that is physically connected to the instrument and can be used for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with AQUIOS Tetra-1 and Tetra-2+ reagents and AQUIOS System software according to the product labeling.

AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 reagent provides identification and enumeration of CD45+, CD45+ Low SS, and CD3+/CD4+, CD3+/CD8+, and CD3+ lymphocyte percentages and absolute counts in peripheral whole blood. AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 provides identification and enumeration of CD45+, CD45+ Low SS, and CD3+, CD3-/CD19+ and CD3-/CD56+CD16+ lymphocyte percentages and absolute counts in peripheral whole blood. Additionally, both panels provide for CD45+ absolute count and CD45+ Low SS absolute count and percentage.

AQUIOS Immuno-Trol and Immuno-Trol Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.

The AQUIOS CL Flow Cytometer uses on-board sample preparation as part of the overall system workflow. The AQUIOS Lysing Reagent Kit is comprised of two readyto-use reagents: Reagent A lyses the red blood cells, Reagent B quenches the solution, slowing the lyse reaction down in preparation for analysis. This reagent system provides a rapid, no-wash, standardized, whole blood lysing solution for sample to sample, and laboratory to laboratory reproducibility.

### Intended Use:

### AQUIOS CL Flow Cytometry System Indications for Use:

The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV). It is used in conjunction with the following reagents and software package.

{9}------------------------------------------------

AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiencv. These reagents provide identification and enumeration of;

- AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent -
- · Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts.
- CD45+ absolute count
- CD45+ Low SS (lymphocytes) percentage and absolute count
- AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent –
- · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
- CD45+ absolute count
- · CD45+ Low SS (lymphocytes) percentage and absolute count

AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with the monoclonal antibody reagents listed above. The off-line analysis must be performed in accordance with the product labeling.

#### AQUIOS Tetra-1 and Tetra-2 Indications for Use:

AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;

- AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent -
- · Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts.
- CD45+ absolute count
- CD45+ Low SS (lymphocytes) percentage and absolute count
- AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent -
- · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
- CD45+ absolute count
- · CD45+ Low SS (lymphocytes) percentage and absolute count

{10}------------------------------------------------

### AQUIOS Immuno-Trol and Immuno-Trol Low Cells Indications for Use:

AQUIOS IMMUNO-TROL Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.

AQUIOS IMMUNO-TROL Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AOUIOS CL Flow Cytometer.

### AQUIOS Lysing Reagent Kit:

AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.

{11}------------------------------------------------

## Technological Characteristics Comparisons to Predicate

## AQUIOS CL Flow Cytometer Device Comparison Tables:

| Similarities | | | | |
|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| | Predicate | | Device | |
| | | FACSCalibur | | |
| Characteristic | CaliBRITE APC beads CaliBRITE 4<br>kit (unlabeled, FITC-, PE-, PE-, PerCP-<br>and APC- labeled CaliBRITE beads),<br>and FACSComp software | CaliBRITE 3 Color and FACSComp | AQUIOS CL Flow Cytometer | |
| Intended Use* | For flow cytometer set up and | For flow cytometer set up and | The AQUIOS CL Flow Cytometer is | |
| | monitoring of instrument | monitoring of instrument | intended for use with in vitro diagnostic | |
| | performance prior to performing | performance. | flow cytometric applications using up to | |
| | reticulocyte enumeration or | | four fluorescent detection channels using | |
| | immunophenotyping applications. | | a blue (488 nm) laser, two light scatter | |
| | Flow cytometry has been found | | detection channels and electronic | |
| | useful in monitoring some forms of | | volume (EV). It is used in conjunction | |
| | immune disease. | | with the following reagents and software | |
| | | | package. | |
| | | | AQUIOS Tetra-1 Panel and AQUIOS | |
| | | | Tetra-2+ Panel monoclonal antibody | |
| | | | reagents are for use on the AQUIOS CL | |
| | | | Flow Cytometer with peripheral whole | |
| | * Only similar parameters of both | | blood for immunophenotyping. These | |
| | devices are presented here. Refer to | | reagents are indicated for use in the | |
| | DxH 800 SE table for other | | immunologic assessment of patients | |
| | parameters. | | having, or suspected of having, immune | |
| | | | deficiency. These reagents provide | |
| Similarities | | | | |
| Characteristic | Predicate<br>FACSCalibur | Device | | |
| | CaliBRITE 3 Color and FACSComp | AQUIOS CL Flow Cytometer | | |
| |…