AESKULISA ANA HEP-2, REF 30-7115US

K081104 · Aesku Diagnostics · LKJ · May 2, 2008 · Immunology

Device Facts

• Record ID: K081104
• Device Name: AESKULISA ANA HEP-2, REF 30-7115US
• Applicant: Aesku Diagnostics
• Product Code: LKJ · Immunology
• Decision Date: May 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG artibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and spectic 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 theumatic diseases and should be used in conjunction with other serological tests and clinical findings.

Device Story

AESKULISA ANA-HEp2 is a solid-phase enzyme immunoassay (EIA) for detecting IgG antibodies against HEp2 cells and specific nuclear antigens in human serum. The device utilizes wells coated with lysed HEp2 cells and specific antigens to capture total antinuclear antibodies (ANAs). It is intended for use in clinical laboratories by trained personnel as an aid in diagnosing systemic rheumatic diseases. Results are interpreted in conjunction with other serological tests and clinical findings. The assay provides a qualitative result, assisting clinicians in identifying patients requiring further evaluation for autoimmune conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid-phase enzyme immunoassay (EIA). Wells coated with lysed HEp2 cells and specific antigens (dsDNA, histones, SS-A, SS-B, Sm, snRNP/Sm, Scl-70, Jo-1, centromeric). Qualitative detection of IgG antibodies.

Indications for Use

Indicated for qualitative detection of IgG antibodies against HEp2 cells and specific antigens (dsDNA, histones, SS-A, SS-B, Sm, snRNP/Sm, Scl-70, Jo-1, centromeric) in human serum to aid in diagnosis of systemic rheumatic diseases. 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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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 2 2008

Aesku Diagnostics. c/o Intertek Testing Services Attn: Mr. Jay Y Kogoma 2307 East Aurora Rd Twinsburg, OH 44087

Re: k081104

Trade/Device Name: AESKULISA ANA-Hep2 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LKJ Dated: April 14, 2008 Received: April 18, 2008

Dear Mr. Kogoma:

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 (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

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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.

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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Robert Becker Jr

Robert L. Becker, Jr., M.D., Ph.I 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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Special 510(k): Device Modification

6.4 Indication for Use

510(K) Number (if Known): KOS 110 4

Device Name: AESKULISA ANA-HEp2

Indication For Use:

AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG artibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and spectic 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 theumatic diseases and should be used in conjunction with other serological tests and clinical findings.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

m chan

Office of In Vitro Diagnostic Device Evaluation and Sa

510(k) K081104

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