THERATEST EL-ANA PROFILES

K051066 · Theratest Laboratories, Inc. · LKP · Oct 7, 2005 · Immunology

Device Facts

• Record ID: K051066
• Device Name: THERATEST EL-ANA PROFILES
• Applicant: Theratest Laboratories, Inc.
• Product Code: LKP · Immunology
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The EL-ANA Profiles™ is an in vitro diagnostic test for the detection and measurement of autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), double-stranded DNA (dsDNA), Smith, RNP/Sm, SSA (Ro) "R, SSB (La) "R (30217), Gould Carding Ribosomal Protein P, Centromere™, and Chromatin (Nucleosomes). This test system is intended as an aid in diagnosis of systemic lupus erythematosus, Sjogren's syndrome, progressive systemic sclerosis (scleroderma), drug-induced lupus and polymyositis.

Device Story

EL-ANA Profiles is an in vitro diagnostic test system; detects and measures specific autoantibodies in patient serum samples. Used in clinical laboratory settings by trained laboratory personnel. Provides qualitative or quantitative results to assist physicians in diagnosing systemic autoimmune diseases including systemic lupus erythematosus, Sjogren's syndrome, scleroderma, drug-induced lupus, and polymyositis. Results are interpreted by clinicians in conjunction with patient clinical presentation and other diagnostic findings to support clinical decision-making.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on performance characteristics typical of immunological test systems for autoantibody detection.

Technological Characteristics

In vitro diagnostic immunological test system; utilizes specific autoantigens (ssDNA, dsDNA, Smith, RNP/Sm, SSA, SSB, Ribosomal Protein P, Centromere, Chromatin) for antibody detection. Class II device; product codes LKP, LJM, MQA, LLL.

Indications for Use

Indicated for in vitro detection and measurement of autoantibodies (ssDNA, dsDNA, Smith, RNP/Sm, SSA, SSB, Ribosomal Protein P, Centromere, Chromatin) as an aid in diagnosing systemic lupus erythematosus, Sjogren's syndrome, progressive systemic sclerosis, drug-induced lupus, and polymyositis.

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

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three stripes forming its body and wings. The eagle is oriented to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Theratest Laboratories, Inc. c/o Dr. Marius Teodorescu President and CEO 1111 N. Main St.

OCT 7 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k051066

Lombard, IL 60148

Trade/Device Name: Teratest EL-ANA Profiles Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: LKP, LJM, MQA, LLL Dated: April 21, 2005 Received: April 27, 2005

Dear Dr Teodorescu:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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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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 807.97). 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PKD 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): __ K051066

Device Name: TheraTest EL-ANA Profiles

Indications For Use:

"The EL-ANA Profiles™ is an in vitro diagnostic test for the detection and measurement of autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), double-stranded DNA (dsDNA), Smith, RNP/Sm, SSA (Ro) "R, SSB (La) "R (30217), Gould Carding Ribosomal Protein P, Centromere™, and Chromatin (Nucleosomes). This test system is intended as an aid in diagnosis of systemic lupus erythematosus, Sjogren's syndrome, progressive systemic sclerosis (scleroderma), drug-induced lupus and polymyositis.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Marie Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K051066