AESKULISA TTG A AND AESKULISA TTG G

K042644 · Aesku, Inc. · MVM · Jun 1, 2005 · Immunology

Device Facts

• Record ID: K042644
• Device Name: AESKULISA TTG A AND AESKULISA TTG G
• Applicant: Aesku, Inc.
• Product Code: MVM · Immunology
• Decision Date: Jun 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The AESKULISA® tTg A is a solid phase enzyme immunoassay for the semiquantitative and qualitative detection of IgA antibodies against tissue transglutaminase (tTG) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings. For in vitro diagnostic use only. The AESKULISA® tTg G is a solid phase enzyme immunoassay for the semiquantitative and qualitative detection of IgG antibodies against tissue transglutaminase (tTG) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings. For in vitro diagnostic use only.

Device Story

AESKULISA tTg A/G are ELISA-based in vitro diagnostic assays for detecting IgA or IgG antibodies against tissue transglutaminase (tTG) in human serum. Device utilizes microplate wells coated with recombinant human tTG and Gliadin-specific peptide antigen. Patient serum is added; specific antibodies bind to antigens. Enzyme-labeled secondary antibody (HRP conjugate) binds to antigen-antibody complex; TMB/H2O2 substrate added to produce colorimetric signal. Intensity measured spectrophotometrically at 450 nm. Results interpreted via cut-off calibrator (qualitative) or standard curve (semi-quantitative). Used in clinical laboratories by trained personnel. Output aids clinicians in celiac disease diagnosis alongside other serological/clinical findings. Benefits include improved diagnostic sensitivity for celiac disease, including in IgA-deficient patients.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Solid-phase enzyme immunoassay (ELISA). Detects IgA or IgG antibodies against tissue transglutaminase in human serum. Class II device (Product Code: MVM).

Indications for Use

Indicated for the semi-quantitative and qualitative detection of IgA or IgG antibodies against tissue transglutaminase (tTG) in human serum to aid in the diagnosis of celiac disease (gluten-sensitive enteropathy). 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 is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 3 2005

AESKU, Inc. c/o Mr. Stanley Ammons 8880 Northwest 18th Terrace Miami, FL 33172

Re: k042644 Trade/Device Name: AESKULISAB tTG A Protocol 30-15-15 REF 7503 AESKULISAB tTG A Protocol 30-30-30 REF 7503 AESKULISA®tTG G Protocol 30-15-15 REF 7504 AESKULISAB tTG G Protocol 30-30-30 REF 7504 Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: September 15,2004 Received: September 27,2004

Dear Mr. Ammons:

This letter corrects our substantially equivalent letter of June 1,2005 regarding AESKULISAB tTG A Protocol 30-15-15 REF 7503, AESKULISAB tTG A Protocol 30-30-30 REF 7503. AESKULISAB tTG G Protocol 30-15-15 REF 7504 and AESKULISAB tTG G Protocol 30-30-30 REF 7504 in which the regulation number was incorrectly entered.

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 (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 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

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Page 2 - Mr. Stanley Ammons

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.

This letter will allow you to continue 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mana Chan signed for
Dr. Robert L. Becker

Robert L. Becker, Jr., M.D., PhD 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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510(k) Number (if known): K042644

Device Name: AESKULISA tTg A

Indications For Use:

AESKULISA tTg A is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig A antibodies against tissue transglutaminase (tTG) in human serum.

The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) 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 - - -

Mana M Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042644

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## Appendix B

510(k) Number (if known): K042644

Device Name:_AESKULISA tTg G

Indications For Use:

AESKULISA tTg G is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig G antibodies against tissue transglutaminase (tTG) in human serum.

The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) 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)

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

Over-The-Counter Use

Maree M. Clark

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042644

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