EL-ANA PROFILES: ANTI-CHROMATIN

K040291 · Theratest Laboratories, Inc. · LJM · Mar 11, 2004 · Immunology

Device Facts

• Record ID: K040291
• Device Name: EL-ANA PROFILES: ANTI-CHROMATIN
• Applicant: Theratest Laboratories, Inc.
• Product Code: LJM · Immunology
• Decision Date: Mar 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

To aid in the diagnosis of systemic lupus erythematosus and related conditions.

Device Story

EL-ANA Profiles: anti-Chromatin is an in vitro diagnostic test used in clinical laboratories. It detects autoantibodies against chromatin to assist physicians in diagnosing systemic lupus erythematosus (SLE) and related autoimmune conditions. The device functions as an immunological test system; it processes patient serum or plasma samples to identify the presence of specific anti-chromatin antibodies. Results are interpreted by healthcare professionals in conjunction with clinical symptoms and other laboratory findings to support diagnostic decision-making. The test provides qualitative or semi-quantitative data, aiding in the clinical assessment of patients presenting with symptoms suggestive of systemic rheumatic diseases.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the device's classification and intended use as an immunological test system.

Technological Characteristics

Solid-phase ELISA; polystyrene microtiter plates coated with purified calf thymus chromatin. Detection via HRP-conjugated goat anti-human IgG (Fc gamma specific). Requires spectrophotometer (450nm or dual 450/620-690nm). Includes proprietary ANA ProCal calibrator using anti-human F(ab')2 coated wells. Manual/semi-automated workflow.

Indications for Use

Indicated for use as an aid in the diagnosis of systemic lupus erythematosus and related conditions.

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

Marius Teodorescu, M.D., Ph.D. President and CEO TheraTest Laboratories 1111 North Main Street Lombard, Illinois 60148

MAR 1 1 2004

Re: k040291

> Trade/Device Name: EL-ANA Profiles:anti-Chromatin Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: II Product Code: LJM Dated: February 24, 2004 Received: February 27, 2004

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 a 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/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Arlett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known) Devicc Name: EL-ANA Profiles: anti-Chromatin

Indications For Use:

ਸਾਰ ਸ਼ੁਰੂ ਕੀਤੀ ਸ

To aid in the diagnosis of systemic lupus erythematosus and related conditions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Approve for m. Chan
(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use & (Per 2) CFR 801.109) OR

Over - The - Counter _________________________________________________________________________________________________________________________________________________________

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