AESKULISA ASCA A by AESKU.INC | FDA 510(k) Summary

AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The AESKULISA ASCA A kit should not be used as a screening test for ASCA, since some Crohn's disease patients do not have ASCA IgA antibodies. The AESKULISA ASCA A kit should be used to compliment, but not to replace or to substitute for ASCA IgG antibody testing. The assay is an aid in the diagnosis of Crohn's disease and should be used in conjunction with other serological tests and clinical findings.

AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is an aid in the diagnosis of Crohn`s disease and should be used in conjunction with other serological tests and clinical findings.

Device Description

solid phase enzyme immunoassay (ELISA) employing purified mannan

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria for device performance or the specifics of a study conducted to prove the device meets such criteria. The document is an FDA 510(k) clearance letter for the AESKULISA ASCA-A and AESKULISA ASCA-G devices, indicating that they were found substantially equivalent to predicate devices. It focuses on regulatory aspects rather than detailed performance study results.

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Missing Information:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
If standalone (algorithm only) performance was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

Summary

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Public Health Service

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AESKU, Inc. c/o Mr. Stanley Ammons U.S. correspondent 8880 Northwest 18th Terrace Miami, Florida 33172

NOV 1 4 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K051492

Trade/Device Name: AESKULISA® ASCA-A, REF 7507. REF 30-7507 AESKULISA® ASCA-G, REF 7508, REF 30-7508 Regulation Number: 21 CFR 866.5785 Regulation Name: Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test system Regulatory Class: Class II Product Code: NBT Dated: May 7, 2005 Received: June 6, 2005

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 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.

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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Robert Beckerh

Robert L. Becker, Jr., MD, P/ 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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Review issues for K051492

510(k) Number (if known): _ K51492 Device Name: AESKULISA ASCA A

Indications For Use:

The AESKULISA ASCA A kit should not be used as a screening test for ASCA, since some Crohn's disease patients do not have ASCA IgA antibodies. The AESKULISA ASCA A kit should be used to compliment, but not to replace or to substitute for ASCA IgG antibody testing. The assay is an aid in the diagnosis of Crohn's disease 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 Son
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

ion with

9/6/2005

510(k) K051442

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Review issues for K051492

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: AESKULISA ASCA-G

Indications For Use:

(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 ------------

Maria Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K051492

Regulation Number and Section

§ 866.5785 Anti-

Saccharomyces cerevisiae (S. cerevisiae ) antibody (ASCA) test systems.(a)
Identification. The Anti-Saccharomyces cerevisiae (S. cerevisiae ) antibody (ASCA) test system is an in vitro diagnostic device that consists of the reagents used to measure, by immunochemical techniques, antibodies toS. cerevisiae (baker's or brewer's yeast) in human serum or plasma. Detection ofS. cerevisiae antibodies may aid in the diagnosis of Crohn's disease.(b)
Classification. Class II (special controls). The special control is FDA's “Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae ) Antibody (ASCA) Premarket Notifications.”