PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT

K020823 · Sanquin Blood Supply Foundation · DFZ · May 14, 2002 · Immunology

Device Facts

• Record ID: K020823
• Device Name: PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
• Applicant: Sanquin Blood Supply Foundation
• Product Code: DFZ · Immunology
• Decision Date: May 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The contents of the Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit will allow quantitative determination of all four IgG Subclasses in at least 50 serum samples with the Beckman IMMAGE® Immunochemistry System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status.

Device Story

The Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit is an in vitro diagnostic reagent set used with the Beckman IMMAGE® Immunochemistry System. It contains sheep antibodies specific to human IgG subclasses. When mixed with patient serum samples, these antibodies form immuno-precipitates with the four subclasses of human IgG. This reaction causes changes in scattered light intensity, which the IMMAGE® system measures at a rate that increases to a peak value. The system uses this peak rate to quantify the IgG subclass concentration. The device is intended for use in clinical laboratory settings by trained personnel. Results are provided to healthcare providers to assist in evaluating a patient's humoral immune status in conjunction with other clinical findings.

Clinical Evidence

No clinical data provided. The submission relies on bench testing to demonstrate performance characteristics for the quantitative determination of IgG subclasses using the IMMAGE® system.

Technological Characteristics

Reagents consist of sheep antibodies to human IgG subclasses. The device utilizes nephelometric sensing principles, measuring changes in scattered light intensity during immuno-precipitation. It is designed for use on the Beckman IMMAGE® Immunochemistry System. The system is an automated clinical laboratory instrument.

Indications for Use

Indicated for the quantitative determination of all four human IgG subclasses in serum samples to aid in the assessment of humoral immune status in patients.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Predicate Devices

• Peliclass™ Human IgG Subclass Nephelometric Array® Kit (K982023)

Submission Summary (Full Text)

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

# MAY 1 4 2002

### EXHIBIT #1

## 510(K) SUMMARY

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: K020823

#### 1. Submitter's Identification:

Sanquin Blood Supply Foundation (formerly the Central Laboratory of the Netherlands Red Cross Blood Transfusion Service) Plesmanlaan 125 1066 CX Amsterdam The Netherlands

Date Summary Prepared: March 4, 2002

#### 2. Name of the Device:

Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit

#### 3. Predicate Device Information:

Peliclass™ Human IgG Subclass Nephelometric Array® Kit, K#982023, Inova Diagnostics, Inc.

#### র্য Device Description:

Sheep antibodies to human IgG subclasses with the four subclasses of human IgG immunoglobulins, forming immuno-precipitates. This reaction consequently causes changes in the intensity of scattered light at a rate that increases gradually at first, then rapidly and finally proceeds through a peak rate of change (peak rate value) for the component being analyzed.

#### 5. Intended Use:

The contents of the Peliclass™ Human IgG Subciass Nephelometric IMMAGE® Kit will allow quantitative determination of all four IgG Subclasses in at least 50 serum samples with the Beckman IMMAGE® Immunochemistry System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status.

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

We trust that the aforementioned responses will be satisfactory.

We will mail, under separate cover, a complete copy of the contents of this fax to Document Mail Center.

If you have any questions, or require additional information, please feel free to call me at [phone] or FAX me at [phone]

Sincerely,

Sanquin Blood Supply Foundation (Formerly the Central Laboratory of the Netherlands Red Cross Blood Transfusion Service)

Susan D. Goldstein - Folke/Sa

Susan D. Goldstein-Falk Official Correspondent for Sanquin Blood Supply Foundation (Formerly the Central Laboratory of the Netherlands Red Cross Blood Transfusion Service)

SDG-F/da

Attachments

A complete list of Attachments is annexed hereto:

Attachment #1: Page 1 of your 510(k) Summary Reflecting the Updated "Indications For Use Form".

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in a simple, sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Susan D. Goldstein-Falk Official Correspondent for Sanquin Blood Supply Foundation c/o MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

MAY 1 4 2002

Re: k020823

Trade/Device Name: Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A,G, M, D AND E Immunological Test System Regulatory Class: II Product Code: DFZ Dated: March 12, 2002 Received: March 14, 2002

Dear Ms. Goldstein-Falk:

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.

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

### Page 2

This letter 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 Butman

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

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

### Attachment #3

1 of of 1 Page

510(k) Number (if known): _ K 020823

Device Name: Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit

Indications For Use:

The contents of the Peliclass™ Human IgG Subclass Nephelometric IMMAGEE The contents of the Pollodetermination of all four IgG Subclasses in at least 50 Nit will allow quantitutive determin IMMAGE Immunochemistry System. The scram Jumploo Min ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . findings to aid in the assessment of the humoral immune status.

Sousan S. Alta.e

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number KO20823

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)