AESKULISA DS DNA G

K041628 · Aesku Diagnostics · LSW · Oct 14, 2004 · Immunology

Device Facts

• Record ID: K041628
• Device Name: AESKULISA DS DNA G
• Applicant: Aesku Diagnostics
• Product Code: LSW · Immunology
• Decision Date: Oct 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

AESKULISA®dsDNA-G is a solid phase enzyme immunoassay with human recombinant double-stranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.

Device Story

AESKULISA®dsDNA-G is a solid-phase ELISA for detecting IgG antibodies against dsDNA in human serum. The device uses microtiter plates coated with human recombinant dsDNA. Patient serum is incubated; anti-dsDNA IgG antibodies bind to the antigen. Unbound components are washed away. Anti-human IgG HRP conjugate is added, followed by TMB substrate, producing a colorimetric reaction proportional to the antibody concentration. The reaction is stopped with 1M HCl and measured at 450 nm using a microplate reader. The device is used in clinical laboratories by trained personnel. Results aid in SLE diagnosis when interpreted alongside other serological tests and clinical findings. The assay provides quantitative and qualitative data to support clinical decision-making.

Clinical Evidence

No clinical data provided in the document; device clearance based on bench testing and performance validation of the immunoassay.

Technological Characteristics

Solid-phase enzyme immunoassay (ELISA). Utilizes human recombinant dsDNA as the capture antigen. Quantitative and qualitative detection of IgG antibodies. Manual or automated microplate processing. In vitro diagnostic use.

Indications for Use

Indicated for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE). For use in conjunction with other serological tests and clinical findings.

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 stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AESKU Diagnostics c/o Mr. Stanley Ammons AESKU, Inc. 8880 NW 18th Terrace Miami, Florida 33172

OCT I 4 2004

Re: k041628 Trade/Device Name: AESKULISA dsDNA G Regulation Number: 21 CFR & 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: II Product Code: LSW Dated: September 13, 2004 Received: September 13, 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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Indications for Use

510(k) Number (if known): K041628

Device Name: AESKULISA dsDNA G

Indications For Use:

AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum.

The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) 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 X AND/OR (Part 21 CFR 801 Subpart D)(21 CFR 807 Subpart C) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

elan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) _Ko41628