(161 days)
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No
The device description and intended use clearly describe a standard ELISA assay, which is a laboratory technique that does not inherently involve AI or ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is described as an immunoassay used for diagnostic purposes (detection of antibodies for Crohn's disease), not for treatment or therapy.
Yes
The device is described as an "aid in the diagnosis of Crohn's disease," which is a clear indication of its diagnostic purpose.
No
The device description explicitly states it is a "solid phase enzyme immunoassay (ELISA) employing purified mannan," which is a laboratory test kit involving physical reagents and processes, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "semi-quantitative and qualitative detection of IgA/IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a person's health status (presence of ASCA antibodies as an aid in diagnosing Crohn's disease).
- Device Description: The description of a "solid phase enzyme immunoassay (ELISA)" is a common type of laboratory test performed in vitro.
- Prescription Use: While not a definitive marker of an IVD, "Prescription Use" often indicates a device used in a clinical laboratory setting for diagnostic purposes.
The core function of the device is to analyze a biological sample in vitro to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AESKULISA ASCA A:
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:
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.
Product codes
NBT
Device Description
AESKULISA ASCA-A and AESKULISA ASCA-G are solid phase enzyme immunoassays (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgA and IgG anti-Saccharomyces cerevisiae antibodies (ASCA), respectively, in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
2
Review issues for K051492
510(k) Number (if known): _ K51492 Device Name: AESKULISA ASCA A
Indications For Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
32
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
3
Review issues for K051492
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: AESKULISA ASCA-G
Indications For Use:
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.
(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
33