AESKULSKA BETA2-GLYCO-A

K062217 · Aesku, Inc. · MSV · Dec 13, 2006 · Immunology

Device Facts

• Record ID: K062217
• Device Name: AESKULSKA BETA2-GLYCO-A
• Applicant: Aesku, Inc.
• Product Code: MSV · Immunology
• Decision Date: Dec 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

AESKULISA® β2-Glyco-A is a solid phase enzyme immunoassay employing native β2-Glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against β2-Glycoprotein I in human serum. The presence of anti-β2-Glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome. AESKULISA® β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2-Glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgG and/or IgM antibodies against β2-Glycoprotein I in human serum. The presence of anti-β2-Glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome. AESKULISA® β2- Glyco-Check is a solid phase enzyme immunoassay employing native β2- Glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against β2- Glycoprotein I in human serum. The presence of anti- β2- Glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

Device Story

AESKULISA® β2-Glyco series are ELISA-based diagnostic kits for detecting IgA, IgG, and IgM antibodies against β2-Glycoprotein I in human serum. The device uses microplate strips coated with purified human β2-Glycoprotein I antigen. Patient serum samples are incubated in the wells; specific antibodies bind to the antigen. After washing, horseradish peroxidase-conjugated anti-human immunoglobulin is added, followed by TMB substrate. The resulting enzymatic colorimetric reaction is stopped with acid and measured spectrophotometrically at 450 nm. The intensity of the yellow color is proportional to the concentration of antibodies in the sample. Results are interpreted qualitatively or semi-quantitatively against a cut-off control or standard calibrator curve. The device is intended for use in clinical laboratories by trained personnel to aid in the diagnosis of thrombotic disorders associated with antiphospholipid syndrome. The output provides clinicians with antibody levels, which, when combined with clinical evaluation, assist in confirming or ruling out APS-related thrombotic conditions.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Solid-phase enzyme immunoassay (ELISA). Antigen: Native β2 glycoprotein I purified from human plasma. Form factor: Microtiter plate-based assay. Analyte: IgA, IgG, and IgM antibodies against β2 glycoprotein I. Intended for professional laboratory use.

Indications for Use

Indicated for patients suspected of having thrombotic disorders related to primary or secondary antiphospholipid syndrome. Used for the detection of IgA, IgG, and/or IgM antibodies against β2 glycoprotein I in human serum to aid in diagnosis.

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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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AESKU, Inc. c/o Mr. David Bell US Correspondent 8880 Northwest 18th Terrace Miami, FL 33172

DEC I 3 2006

Re: k062217

Trade/Device Name: AESKULISA® ß2-Glyco-A Protocol 30-30-30, AESKULISA® B2-Glyco-A Protocol 30-15-15, AESKULISA® ß2-Glyco-GM Protocol 30-30-30, AESKULISA® β2-Glyco-GM Protocol 30-15-15, AESKULISA® β2-Glyco-Check Protocol 30-30-30, AESKULISA® β2-Glyco-Check Protocol 30-15-15 Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MSV Dated: July 31, 2006 Received: August 3, 2006

Dear Mr. Bell:

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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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/industry/support/index.html.

Sincerely yours,

Robert A. Bertoch

Robert L. Becker, Jr., M.D., Pb.D. 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):_ 4062217

Device Name: AESKULISA ß2-Glyco-A

Indications For Use:

AESKULISA ß2 Glyco-A is a solid phase enzyme immunoassay employing native ß2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum.

The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

m chan
Division Sign-Off

510(k) K062217

(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)

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510(k) Number (if known): ¥0622 17

Device Name: AESKULISA β2-Glyco-GM

Indications For Use:

AESKULISA ß2 Glyco-GM is a solid phase enzyme immunoassay employing native ß2 glycoprotein I highly purified from human plasma for the separate semiquantitative and qualitative detection of IgG and/or IgM antibodies against β2 glycoprotein I in human serum.

The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

Maria M. Clan
Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K062217

(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

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

(Part 21 CFR 801 Subpart D)

3-2

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510(k) Number (if known): .

Device Name: AESKULISA B2-Glvco-Check

Indications For Use:

AESKULISA ß2 Glyco-Check is a solid phase enzyme immunoassay employing native ß2 glycoprotein 1 highly purified from human plasma for the combined semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against ß2 glycoprotein I in human serum.

The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

Marie M. Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K062217

(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)