CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A

K030408 · Beckman Coulter, Inc. · GKZ · Mar 4, 2003 · Hematology

Device Facts

• Record ID: K030408
• Device Name: CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A
• Applicant: Beckman Coulter, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Mar 4, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. When used in conjunction with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained. CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. This reagent can also provide the total lymphocyte percentage.

Device Story

Reagents consist of four murine monoclonal antibodies conjugated to fluorochromes; specific for cell surface antigens. Input: whole blood samples processed via flow cytometry (e.g., COULTER EPICS XL, FC 500). Principle: antibodies bind to discrete antigenic determinants on cell surfaces; red blood cells lysed; remaining white blood cells analyzed by flow cytometer. Output: identification and enumeration of lymphocyte subpopulations (CD3+, CD4+, CD8+, CD19+, CD56+) and CD4/CD8 ratios. Used in clinical laboratories by trained operators. Modification allows reagents to be used as standalone products on equivalent flow cytometers, enabling manual adjustment of gating and operational parameters to optimize results, rather than relying on the automated tetraONE system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Murine monoclonal antibodies conjugated to fluorochromes (FITC, PE, ECD, PC5). Sensing principle: flow cytometry (light scatter and fluorescence detection). Compatible with COULTER EPICS XL, FC 500, or equivalent flow cytometers. Standalone reagent format. Manual gating and parameter adjustment capability.

Indications for Use

Indicated for in vitro diagnostic identification and enumeration of lymphocyte subpopulations (T cells, B cells, NK cells) and calculation of CD4/CD8 ratios in whole blood samples via flow cytometry.

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

• tetraONE System for EPICS XL Flow Cytometry System (K990172)

Submission Summary (Full Text)

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KO3O4O8

MAR 0 4 2003

## Summary of Safety and Effectiveness for CYTO-STAT® tetraCHROME™ CD45-Section 1 D: FITC/CD4-PE/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents

#### 1.0 General Information

| Device Generic Name(s): | Lymphocyte Immunophenotyping monoclonal antibody<br>reagents |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name(s): | CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-<br>ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-<br>FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody<br>Reagents |
| Device Classification: | CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-<br>ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-<br>FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody<br>Reagents are Class II medical devices. |
| Applicant Name and Address: | Beckman Coulter, Inc.<br>Cellular Analysis Division<br>11800 SW 147 Avenue<br>Miami, FL 33196-2500 |
| Date: | February 6, 2003 |

#### 2.0 Legally Marketed Device(s)

The CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents claims substantial equivalence to the previously cleared tetraONE System for EPICS XL Flow Cytometry System with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and with CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent

FDA 510(k) Number(s): K990172

#### 3.0 Device Description

The products are:

The CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent. Each is a combination of four murine monoclonal antibodies, each conjugated to a different fluorochrome and specific for a different cell surface antigen. Specifically.

> CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 . Monoclonal antibody reagent allows the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole

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blood flow cytometry. When used in conjunction with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained.

CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal antibody reagent . allows the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can be obtained as well.

#### Principle of Method: 4.0

The CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents are combinations of four murine monoclonal antibodies, each conjugated to a different fluorochrome and specific for a different cell surface antigen. The test depends on the ability of a monoclonal antibody to bind to the surface of cells expressing discrete antigenic determinants. Red blood cell are lysed and the remaining white blood cells are analyzed on a flow cytometer (COULTER EPICS XL, FC 500 or equivalent flow cytometer). The analysis may be automated, as with XL with System II software which automates standardization of light scatter, fluorescence intensities and adjustment of color compensation settings and tetraONE SYSTEM software which provides automated analysis of lymphocyte subpopulations. Alternatively, the operator may perform the analysis by adjusting and other operational parameters to optimize results when working with non-routine samples.

#### 5.0 Indications for Use:

CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. When used in conjunction with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained. CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can be obtained as well.

#### 6.0 Description of the modification:

The currently marketed tetraONE System for EPICS XL Flow Cytometry System with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and with CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent is an automated analysis method for simultaneous identification and enumeration of lymphocvte subpopulations (CD3+, CD4+, CD8+, CD19+and CD56+) combining four-color fluorescent monoclonal antibody reagents, quality control reagents, optional absolute count reagent and software. This premarket notification is for the use of the two monoclonal antibody reagent system components as stand alone reagents on any equivalent flow cytometer system, allowing the operator to manually adjust gating and other operational parameters to optimize results at their discretion.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Premarket Product Regulatory Compliance Beckman Coulter, Inc. 11800 SW 147 Avenue MC 31-B06 Miami, Florida 33196-2500

MAR 0 4 2003

k030408 Re:

> Trade/Device Name: CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents Regulation Number: 21 CFR § 864.5220 Regulation Name: Lymphocyte Immunophenotyping monoclonal antibody reagents Regulatory Class: II Product Code: GKZ Dated: February 6, 2003 Received: February 7, 2003

Dear Dr. Sugrue:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE Section 1C:

Not assigned 510(k) Number (if known): CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-Device: ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents

### Indications For Use:

CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. When used in conjunction with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained.

CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. This reagent can also provide the total lymphocyte percentage.

### 21 CFR 864.5220

Lymphocyte Immunophenotyping monoclonal antibody reagents

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

**Over-The-Counter Use**

Churchen Bruton

(Division/Sign/ Division of Clinical Laboratory Devices 510(k) Number 8030408

Beckman Coulter, Inc. Special 510(k): Device Modification TetraCHROME_Rgts_510k.doc

CYTO-STAT® tetraCHROME™ Monoclonal Antibodies