AESKULISA ANA HEP-2

K040953 · Aesku, Inc. · LJM · Jun 23, 2004 · Immunology

Device Facts

• Record ID: K040953
• Device Name: AESKULISA ANA HEP-2
• Applicant: Aesku, Inc.
• Product Code: LJM · Immunology
• Decision Date: Jun 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

AESKULISA ANA-Hep2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against Hep2 cells in human serum. Each well is coated with lysed Hep2 cells and specific antigens. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for Hep2 immunofluorescence test (IFT). 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 ANA-Hep2 is a qualitative ELISA test for detecting IgG antibodies against Hep2 cells and specific nuclear antigens (dsDNA, histones, SS-A, SS-B, Sm, snRNP/Sm, Scl-70, Jo-1, centromeric) in human serum. The device uses microtiter plates coated with lysed Hep2 cells and antigens. Patient serum is incubated in the wells; if ANA antibodies are present, they bind to the antigens. After washing, anti-human IgG HRP conjugate is added, followed by TMB substrate. The resulting enzymatic colorimetric reaction (blue to yellow after acid stop) is measured at 450 nm using a microtiter plate reader. The optical density (OD) is proportional to the antibody concentration. The test is performed in a clinical laboratory setting by trained personnel. Results assist clinicians in diagnosing systemic rheumatic diseases when combined with other clinical and serological data.

Clinical Evidence

No clinical trials were performed. Substantial equivalence was established via analytical performance testing and a method comparison study. Method comparison with the predicate device (n=59) showed 100% agreement (57 positive, 2 negative). Analytical specificity was demonstrated using 57 characterized patient sera (all positive) and 91 negative control sera (11 positive for other antigens, 80 healthy donors). Precision (intra-assay and inter-assay) showed %CVs ranging from 1.5% to 3.1%. Linearity/recovery was confirmed via serial dilutions.

Technological Characteristics

Solid-phase enzyme immunoassay (EIA). Wells coated with lysed HEp-2 cells and specific nuclear antigens. Qualitative detection of IgG antibodies. Manual or automated plate processing.

Indications for Use

Indicated for the qualitative detection of IgG antibodies against Hep2 cells in human serum to aid in the diagnosis of systemic rheumatic diseases. Intended for use in conjunction with other serological tests and clinical findings. 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

JUN 2 3 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Stanley Ammons US Correspondent AESKU Inc. 8880 Northwest 18th Terrace Miami, FL 33172

k040953 Re: Trade/Device Name: AESKULISA ANA Hep-2 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test systems Regulatory Class: Class II Product Code: LKJ Dated: June 8, 2004 Received: June 16, 2004

Dear Mr. Ammons:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to region) to regions of the Medical Device Amendments, or to connine.co. pror to May 20, 1970, the oncordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic (11ct) that as novice, subject to the general controls provisions of the Act. The r ou may, mercrore, maines of the Act include requirements for annual registration, listing of general controls provisions of tactice, 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 your device is enabilitional controls. Existing major regulations affecting your device It may be subject to such additions combiner - Mations (CFR), Parts 800 to 895. In addition, FDA can be found in Title 21, Occerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean F lease be advised that I Dris issualles or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of ally it dollars and regulations and regulations, but not limited to: registration and listing (21 Comply with an the Ace of Equilters, 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your evice to a legally premarket notification. "The PDA midning of basisan for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desne specific information assuments of your device, please contact the Office of In or questions of the promotion and acreensing or your be and services of the Vitro Diagnostic Device Device Livanian and bareer an (Secondon' (21CFR Part 807.97). fegulation entitled, "Misolanding of responsibilities under the Act from the You may offain offer general miormation on Jour 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,

Roba H. Beckwith

Robert L. Becker, Jr. MD, PH. 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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## Addendum C for K040953

510(k) Number (if known):_K040953_____________________________________________________________________________________________________________________________________________

Device Name: AESKULISA ANA HEp-2_

## Indications For Use:

AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative Adelection of IgG antibodies against HEp-2 cells in human serum. Each well is coated with lysed HEp2 cells and specific antigens. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A(Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT).

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

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

Maria Chan

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Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k) K040953