AESKULISA ENA 6 S

K041753 · Aesku Diagnostics · LLL · Jul 14, 2004 · Immunology

Device Facts

• Record ID: K041753
• Device Name: AESKULISA ENA 6 S
• Applicant: Aesku Diagnostics
• Product Code: LLL · Immunology
• Decision Date: Jul 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

AESKULISA® ENA 6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl-70, Jo-1 and purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.

Device Story

AESKULISA® ENA 6S is a solid-phase enzyme-linked immunosorbent assay (ELISA) for qualitative detection of IgG autoantibodies in human serum. Device utilizes microplate wells coated with a pool of recombinant (SS-B, SS-A 52 kDa, Scl-70, Jo-1) and native (snRNP/Sm, Sm, SS-A 60 kDa) antigens. Patient serum is added; specific antibodies bind to immobilized antigens. After washing, horseradish peroxidase-conjugated anti-human IgG is added, followed by TMB substrate. Color intensity, measured via microplate reader at 450 nm, is proportional to antibody concentration. Used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing systemic rheumatic diseases when combined with other serological and clinical data.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on bench-level performance characteristics of the immunoassay.

Technological Characteristics

Solid-phase enzyme immunoassay (ELISA). Microtiter wells coated with recombinant and purified native human antigens (SS-B, SS-A 52 kDa, Scl 70, Jo-1, snRNP/Sm, Sm, SS-A 60 kDa). Detects IgG antibodies in human serum.

Indications for Use

Indicated for the qualitative detection of IgG antibodies against six cellular and nuclear antigens (SS-A, SS-B, Sm, RNP/Sm, Scl-70, Jo-1) in human serum to aid in the diagnosis of systemic rheumatic diseases (e.g., SLE, Sjögren’s syndrome, scleroderma, polymyositis). 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 4 2004

Mr. Stanley Ammons US Correspondent Aesku. Inc. 8880 NW 18th Terrace Miami, FL 33172

Re: k041753 Trade/Device Name: AESKULISA ENA6 S Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LLL Dated: June 12, 2004 Received: June 29, 2004

Dear Mr. Ammons:

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,

Robert L. Becker, Jr.

Robert L. Becker, Jr., M.D., Ph. 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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3 Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K041753

Device Name: AESKULISA ENA6 S

Indications For Use:

AESKULISA ENA 6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and purified native human snRNP/Sm, Sm and SS-A 60 kDa.

The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.

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

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

Prescription Use _ (Part 21 CFR 801 Subpart D)

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

Mana Chan
Division Sign-Off

**Office of In Vitro Diagnostic Device Evaluation and Safety**

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510(k) K041753