CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES

K060423 · Dakocytomation California, Inc. · GKZ · Aug 15, 2006 · Hematology

Device Facts

• Record ID: K060423
• Device Name: CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES
• Applicant: Dakocytomation California, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Aug 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The CyAn™ DXD Flow Cytometer with Summit™ software and user manual is intended for use as an In-Vitro Diagnostic device for identification and enumeration of the relative fraction of lymphocyte subsets in human peripheral whole blood using flow cytometry, i.e., identifies the relative percentage of CD4 and CD8 T-cells as demonstrated by gating on CD3 positive cells. TC-660, the three color combination, CD3, CD4 and CD8 intended for use to identify the relative percentages of CD4 and CD8 positive T cells. Calibrators, FluoroSpheres (Dako K0110) are intended for in vitro use on the Dako CyAn™ DXD flow cytometer with Summit™ software to adjust detector voltages and monitor daily instrument performance. CD3 FITC (Dako F0818), CD3 RPE (R0810), and CD3 APC (C7225) single antibody- fluorochrome conjugates are intended to be used for setting fluorescence compensation parameters using automated compensation.

Device Story

Bench-top flow cytometer; uses multi-laser stimulation (up to 3 lasers) to analyze fluorescence-tagged lymphocytes in peripheral whole blood. Input: whole blood samples stained with MultiMix™ triple-color reagents (CD3/CD4/CD8). Operation: cells flow single-file past lasers; fluorescence, forward scatter (FSC), and side scatter (SSC) detected. Summit™ software processes signals to identify T-cell subsets via gating on CD3+ cells. Daily calibration uses FluoroSpheres; automated compensation uses single-antibody conjugates. Used in clinical labs by trained personnel. Output: relative percentages of CD4 and CD8 T-cell subsets. Assists clinicians in immunophenotyping; provides quantitative data for lymphocyte subset analysis.

Clinical Evidence

Bench testing only. Precision studies (n=30 aliquots) showed SDs 0.17-1.02. Linearity (0-100% range) showed R2 ≥ 0.99. Method comparison (n=92 specimens) against predicate reagents showed R2 > 0.95 for all CD4/CD8 populations. Specificity verified in 5 healthy donors. Reference ranges established in 161 healthy adults.

Technological Characteristics

Bench-top flow cytometer; multi-laser (up to 3) excitation (365-650 nm). Uses fluorescence-tagged antibodies (FITC, RPE, APC). Includes automated compensation and quality control algorithms. Software-driven (Summit).

Indications for Use

Indicated for clinical immunophenotyping of human peripheral whole blood to identify and enumerate CD3, CD4, and CD8 lymphocyte subsets.

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 FACSCalibur IVD Flow Cytometer (K974360)

Submission Summary (Full Text)

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#### 510(k) Summary

# AUG 1 5 2006

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | K060423 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Dako.<br>6392 Via Real<br>Carpinteria, CA 93013<br>PH. 805.566.6655 FX. 805.566.0866<br>Establishment registration number: 2022180 |
| Contact: | Tiffany D. Almeroth, RAC<br>Manager, Regulatory Affairs<br>PH. 805.566.3041 |
| Date Summary Prepared: | May 12, 2006 |
| Device Name(s): | CyAn™ DXD with Summit™ Software<br>(Code CY204-30, CY205-30) |
| | MultiMix™ Triple-Colour Reagent (Code TC660)<br>Anti-Human CD8/FITC<br>Anti-Human CD4/RPE<br>Anti-Human CD3/APC |
| | FluoroSpheres (Code K0110)<br>Anti-human CD3 FITC (Code F0818)<br>Anti-human CD3 RPE (Code R0810)<br>Anti-human CD3 APC (Code C7225) |
| Device Classification: | Class II, Automated Differential Cell Counter<br>21 CFR 864.5220<br>Product code: GKZ |
| Panel: | Hematology and Pathology Devices Panel<br>Division of Clinical Laboratory Devices. |
| Predicate Devices: | B-D FACS Calibur, K974360<br>Dako CD3/CD4 (FR875), K961701<br>Dako CD3/CD8 (FR881), K955909<br>Dako CD45/CD14 (FR700), K964974<br>BD CalBRITE Beads, K973483 |

Device Description:

The Dako CyAn™ DXD device is a bench-top flow cytometer system relying on

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multiple (up to three) laser stimulation of fluorescence tagged lymphocytes. It is used with the Dako MultiMix, a triple color reagent; one each to CD3, CD4 and CD8, conjugated to fluorochromes APC(allophycocyanin), r-phycoerythrin, and fluorescein isothiocynate, which are balanced to identify the dual positive T-cell populations (CD3+CD4+ and CD3+CD8+) in peripheral blood lymphocytes. The instrument requires daily set-up with Dako FluoroSpheres consisting of a set of 5 bead populations having different fluorescent intensities and one nonfluorescent bead population. The combination of fluorochromes enables excitation by light of any wavelength from 365-650 nm. The CyAn DXD utilizes anti-human CD3 conjugated with FITC, RPE and APC to perform autocompensation.

#### Intended Use:

#### For In Vitro Diagnostic Use

| CyAn™ DXD | The CyAn DxD Flow Cytometer with Summit™ software and user<br>manual is intended for use as an In-Vitro Diagnostic device for<br>identification and enumeration of the relative fraction of lymphocyte<br>subsets in human peripheral whole blood using flow cytometry, i.e.,<br>identifies the relative percentages of CD4 and CD8 T-cells as<br>demonstrated by gating on CD3 positive cells. TC-660, the three color<br>combination, CD3, CD4 and CD8 is intended for use to identify the<br>relative percentages of CD4 and CD8 positive T cells. Calibrators, Dako<br>K0110 FluoroSpheres are intended for in vitro use on the Dako CyAn™<br>DXD flow cytometer with Summit™ software to adjust detector voltages<br>and monitor daily instrument performance. CD3 FITC (Dako F0818),<br>CD3 PE (R0810), and CD3 APC (C7225) single antibody-fluorochrome<br>conjugates are intended to be used for setting fluorescence<br>compensation parameters using automated compensation. |
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#### Substantial Equivalence:

The Dako CvAn™ DXD flow cytometer is substantially equivalent to the BD FACS Calibur whereby these instruments are used to identify and enumerate lymphocyte subsets using fluorescence qating and automated quality control algorithms. These products share similar technology and testing methodology. The additional parameters offered by the CvAn DXD for identification and enumeration over the predicate device does not introduce any new issues of safety and effectiveness.

#### Performance Characteristics:

Performance characteristics evaluated in support of the CVAn DXD and its associated components include results on linearity, precision, accuracy, specificity and carryover. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate devices listed above.

Therefore, based on the information provided in this premarket notification, Dako

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concludes that the devices listed above are safe, effective and substantially equivalent
to, their, respective, predicate, daviese, in the indivation in the institution in a to their respective predicate devices in substantant substantially equivalent
materials, operational principles, and intended materials, operational principles, and intended use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol, with its wings forming a curved shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Tiffany D. Almeroth, RAC Manager, Regulatory Affairs Dako North America, Inc. 6392 Via Real Carpinteria, California 93013

AUG 1 5 2006

Re: k060423

> Trade/Device Name: CyAn™ DXD Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 3, 2006 Received: August 8, 2006

Dear Ms. Almeroth:

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 indice increases in 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 provisions of ine Act.
I annual registerations of the Act include requirements for annual registration, isting 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 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.

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Page 2 --

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 80.97). 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 the Acc Illum the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobetz Beckerh

Robert L. Becker, Jr., MD, Ph Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K060423

Device Name: CyAn™ DXD

Indications For Use:

Clinical immunophenotyping using the CyAn DXD flow cytometer, a lyse wash sample preparation method, for identification and enumeration of CD3, CD4 and CD8 lymphocyte subsets using TC-660.

For In-Vitro Diagnostic Use

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Divisi

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060423