AESKULISA CARDIOLIPIN AGM

K040463 · Aesku, Inc. · MID · May 12, 2004 · Immunology

Device Facts

• Record ID: K040463
• Device Name: AESKULISA CARDIOLIPIN AGM
• Applicant: Aesku, Inc.
• Product Code: MID · Immunology
• Decision Date: May 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

AESKULISA Cardiolipin-AGM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the semiquantitative and qualitative detection of IgA, IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein I which are only expressed when ß2glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

Device Story

AESKULISA Cardiolipin series are solid-phase enzyme immunoassays (ELISA) for detecting anti-cardiolipin antibodies in human serum. The device uses purified cardiolipin and native human ß2-glycoprotein I as antigens to capture antibodies that recognize the cardiolipin/ß2-glycoprotein I complex. Performed in clinical laboratories by trained technicians; results are interpreted by physicians alongside other serological tests and clinical findings to aid in diagnosing SLE and APS. The assay provides semiquantitative and qualitative data to support clinical decision-making regarding autoimmune disease management.

Clinical Evidence

Bench testing only. Analytical performance included precision (intra-assay CV 0.4-7.6%, inter-assay CV 0.7-9.5%), linearity (recovery 84-108.7%), and analytical sensitivity (1.0 APL/GPL/MPL/mL). Method comparison studies were conducted using 111 samples for GM assays and 81 samples for A/Check assays against predicate devices. Agreement varied by isotype: IgG (95.5% total agreement), IgM (79.3% total agreement), IgA (86.1% total agreement), and Check (89.9% total agreement). Discrepancies were analyzed against clinical diagnosis.

Technological Characteristics

Solid-phase enzyme immunoassay (ELISA). Utilizes purified cardiolipin and native human ß2-glycoprotein I as antigens. Designed for detection of IgA, IgG, and IgM antibody classes in human serum.

Indications for Use

Indicated for the detection of IgA, IgG, and/or IgM anti-cardiolipin antibodies in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE) and primary/secondary anti-phospholipid syndrome (APS). For prescription use only.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

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 features three abstract human figures connected at the shoulders and facing to the right. The figures are rendered in black and have a flowing, wave-like appearance. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 2 2004

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

k040463 Re:

Trade/Device Name: AESKULISA® Cardiolipin AGM AESKULISA® Cardiolipin A AESKULISA® Cardiolipin GM AESKULISA® Cardiolipin Check Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autobodies immunological test system Regulatory Class: Class II Product Code: MID Dated: May 3, 2004 Received: May 7, 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 equivalcnt (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); labcling (21 CFR Parts 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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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. Aralett

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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## 3 Indications for use

510(k) Number (if known): Kn40463

Device Name:_AESKULISA Cardiolipin-AGM__

Indications For Use:

AESKULISA Cardiolipin-AGM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the semiquantitative and qualitative detection of IgA, IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein I which are only expressed when ß2glycoprotein I interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

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

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

Marie Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040463

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## 510(k) Number (if known): KOHO40463

Device Name:_AESKULISA Cardiolipin-A_

Indications For Use:

AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the semiquantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein | which are only expressed when ß2-glycoprotein | interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

Prescription Use ✔ (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1

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

Maria Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Ko 40463 510(k)________________________________________________________________________________________________________________________________________________________________________

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## 510(k) Number (if known): K040463

Device Name: AESKULISA Cardiolipin-GM

Indications For Use:

AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the semiquantitative and qualitative detection of IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein I which are only expressed when ß2-glycoprotein I interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

Prescription Use __ V (Part 21 CFR 801 Subpart D) AND/OR

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

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

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

Maria Chen

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_ Ko 40463

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## 510(k) Number (if known): 30404 (c3

Device Name: AESKULISA Cardiolipin-Check

Indications For Use:

AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the combined semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein I which are only expressed when ß2glycoprotein I interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

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

Mario Clon

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Ko40463