FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST

K013263 · Fred Hutchinson Cancer Research Center · LKP · Jul 29, 2002 · Immunology

Device Facts

• Record ID: K013263
• Device Name: FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
• Applicant: Fred Hutchinson Cancer Research Center
• Product Code: LKP · Immunology
• Decision Date: Jul 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Indications for Use

The Fred Hutchinson Cancer Research Center Anti-SR test is an enzyme immunoassay (EIA) for the detection and semiquantitative measure of human antibodies against a type of ribonucleoproteins (RNPs) called SR Proteins. The test is intended as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE) .

Device Story

FHCRC Anti-SR test is an enzyme immunoassay (EIA) designed to detect and semiquantitatively measure human antibodies against SR proteins (ribonucleoproteins). Used as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE). Operated by laboratory personnel in a clinical setting. Provides results to healthcare providers to assist in clinical decision-making regarding SLE diagnosis.

Technological Characteristics

Enzyme immunoassay (EIA) for detection of antibodies against SR proteins. In vitro diagnostic test system.

Indications for Use

Indicated for the detection and semiquantitative measurement of human antibodies against SR proteins (ribonucleoproteins) to aid in the diagnosis of Systemic Lupus Erythematosis (SLE).

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUL 2 9 2002

Mark Roth, Ph.D. Fred Hutchinson Cancer Research Center 1100 Fairview Avenue, North P.O. Box 19024 Seattle, Washington 98109-1024

Re: k013263

Trade/Device Name: Fred Hutchinson Cancer Research Center (FHCRC) Anti-SR Test Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: II Product Code: LKP Dated: May 30, 2002 Received: June 4, 2002

Dear Dr. Roth:

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 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 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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## 510(k) Number

101321

Device Name:

FHCRC Anti-SR Test

Indications For Use:

The Fred Hutchinson Cancer Research Center Anti-SR test is an enzyme immunoassay (EIA) for the detection and semiquantitative measure of human antibodies against a type of ribonucleoproteins (RNPs) called SR Proteins. The test is intended as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE) .

J.P. Reeve for S. Attie

510(k) Num

(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