RHIGENE MESACUP-2 TEST RNP, MODEL M7741

K022017 · Rhigene, Inc. · LKO · Aug 14, 2002 · Immunology

Device Facts

• Record ID: K022017
• Device Name: RHIGENE MESACUP-2 TEST RNP, MODEL M7741
• Applicant: Rhigene, Inc.
• Product Code: LKO · Immunology
• Decision Date: Aug 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The RhiGene MESACUP-2 TEST RNP is a semi-quantitative enzyme-linked immunosorbent assay for the detection of antibodies to RNP in human serum. The RhiGene MESACUP-2 TEST RNP is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

Device Story

MESACUP-2 TEST RNP is an enzyme-linked immunosorbent assay (ELISA) kit; detects anti-RNP antibodies in human serum samples. Used in clinical laboratory settings by trained personnel. Input: human serum; process: antigen-antibody binding reaction; output: semi-quantitative measurement of anti-RNP antibodies. Results assist clinicians in diagnosing autoimmune diseases. Device provides diagnostic aid; does not replace clinical evaluation.

Clinical Evidence

No clinical data provided in the document. Bench testing only.

Technological Characteristics

Semi-quantitative enzyme-linked immunosorbent assay (ELISA). In vitro diagnostic test system. Class II device. Product code LKO.

Indications for Use

Indicated for the semi-quantitative detection of anti-RNP antibodies in human serum as an aid in diagnosing autoimmune diseases. For prescription use only.

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## AUG 1 4 2002

Mr. Yusuke Kobe Vice President RhiGene, Inc. 455 State Street Suite 104 Des Plaines, Illinois 60016

Re: k022017

> Trade/Device Name: RhiGene MESACUP-2 Test RNP Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody, Immunological Test System Regulatory Class: II Product Code: LKO Dated: June 18, 2002 Received: June 20, 2002

Dear Mr. Kobe:

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. Iisting 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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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 Putman

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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## Indications for Use Statement

Konzo17 510(k) Number:____

Device Name: RhiGene MESACUP-2 TEST RNP

Indications for Use:

The RhiGene MESACUP-2 TEST RNP is a semi-quantitative enzyme-linked immunosorbent assay for the detection of antibodies to RNP in human serum. The RhiGene MESACUP-2 TEST RNP is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Sousan S. Altaie

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_KO22

Prescription Use OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)