IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ

K022528 · Iq Corp. · GKZ · Sep 11, 2002 · Hematology

Device Facts

• Record ID: K022528
• Device Name: IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ
• Applicant: Iq Corp.
• Product Code: GKZ · Hematology
• Decision Date: Sep 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD19+ and total CD3+ Iymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/IgG1 CyQ may be used. IQ Prep Reagent CD45 FITC/ CD8 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD8+, and dual CD3+/CD8+ lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ may be used. IQ Prep Reagent CD45 FITC/ CD4 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD3 positive, total CD4 positive, and dual CD3 positive lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ is used. IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ is a triple-color murine monoclonal antibody reagent used to monitor the level of nonspecific antibody binding in cell surface staining procedures that use the other IQ Prep Reagents are comprised of the monoclonal antibody to CD45, that is labeled with the fluorochrome FITC, and two other IgG1 subclass monoclonal antibodies that are conjugated to either PE or CyQ fluorochromes.

Device Story

Reagents consist of murine monoclonal antibodies conjugated to fluorochromes (FITC, R-PE, CyQ). Used in clinical laboratories by trained personnel to stain whole blood samples. Flow cytometer detects fluorescence signals from labeled cells; software identifies and enumerates specific lymphocyte populations based on surface marker expression. Output provides percentage of target cell subsets; assists clinicians in immunological assessment and monitoring. Isotypic control reagent monitors non-specific binding to ensure accuracy of staining results.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Triple-color murine monoclonal antibody reagents; fluorochromes include FITC, R-PE, and CyQ. Designed for use with flow cytometry instrumentation. Reagents function via specific antigen-antibody binding for cell surface marker identification.

Indications for Use

Indicated for identification and enumeration of lymphocyte subsets (CD3+, CD4+, CD8+, CD19+) in human whole blood via flow cytometry. Includes isotypic control for monitoring non-specific staining.

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.”

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

IO Corporation . c/o Harold G. Haines, Ph.D. President South Florida BioAssociates, Inc. 11511 SW 127th Street Miami, Florida 33176

od and Drug Administratio 098 Gaither Road Rockville MD 20850

k022528 Re:

> Trade/Device Name: IQ Products Triple-Color Flow Cytometry Reagents IO Prep Reagent CD45 FITC/CD4 R-PE/CD3 CyQ IQ Prep Reagent CD45 FITC/CD8 R-PE/CD3 CyQ IQ Prep Reagent CD45 FITC/CD19 R-PE/CD3 CyQ IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: July 2, 2002 Received: July 31, 2002

Dear Dr. Haines:

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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This Jetter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and. additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 4

#### 510(k) Number (if known): K022528

Device Name:

IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ.

## Indications For Use:

IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD19+ and total CD3+ Iymphoctyes in whole blood by flow cytometry.

To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/IgG1 CyQ may be used.

Jevheni Bautski

Division Sigh-Off Division of Clinical Laboratory Devices 510(k) Number-

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format) 1-2-96

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.

## 510(k) Number (if known): K022528

Device Name:

IQ Prep Reagent CD45 FITC/ CD8 R-PE/ CD3 CyQ

#### Indications For Use:

IQ Prep Reagent CD45 FITC/ CD8 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD8+, and dual CD3+/CD8+ lymphoctyes in whole blood by flow cytometry.

To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ may be used.

Josephine Briutati

on of Clinical I aboratory I 510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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.

.
1974

# 510(k) Number (if known): K022528

:

:

Device Name:

. '

.

# IQ Prep Reagent CD45 FITC/ CD4 R-PE/ CD3 CyQ

# Indications For Use:

IQ Prep Reagent CD45 FITC/ CD4 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD3 positive, total CD4 positive, and dual CD3 positive lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ is used.

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K022528 |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per CFR 801.109)
✓

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

OR

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Page 4 of 4

#### 510(k) Number (if known): K022528

Device Name:

IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ

Indications For Use:

IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ is a triple-color murine monoclonal antibody reagent used to monitor the level of nonspecific antibody binding in cell surface staining procedures that use the other IQ Prep Reagents are comprised of the monoclonal antibody to CD45, that is labeled with the fluorochrome FITC, and two other IgG1 subclass monoclonal antibodies that are conjugated to either PE or CyQ fluorochromes.

Chrystine Bratki

(Division Sidn Division of Clinical Laboratory Devices 510(k) Number

:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per CFR 801.109)

OR

Over-The-Counter Use

(Optional Format) 1-2-96