(188 days)
An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum.
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgA ELISA.
This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and grants permission to market it. It does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.
Therefore, I cannot extract the following information from the given text:
- A table of acceptance criteria and the reported device performance: This information is typically found in the technical documentation submitted with the 510(k) application, not in the clearance letter itself.
- Sample size used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not available.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable to an ELISA diagnostic kit in this context, but also not available.
- If a standalone performance (algorithm only) was done: Not applicable to an ELISA kit, but also not available.
- The type of ground truth used: Not explicitly stated for the studies.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document states the "Indications For Use" which is: "An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD)." This is the purpose of the device, but not its performance metrics or study details.
To get the information you are seeking, you would need to refer to the actual 510(k) submission documentation or scientific publications related to the ImmuLisa ASCA IgA ELISA, which are not provided here.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 8 2004
Mr. Kevin J. Lawson Director of Regulatory Affairs IMMCO Diagnostics, Inc. 60 Pineview Dr. Buffalo, NY 14228
Re: K032860
Trade/Device Name: ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgA ELISA Regulation Number: 21 CFR 866.5785 Regulation Name: Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems Regulatory Class: Class II Product Code: NBT Dated: December 23,2003 Received: February 10, 2004
Dear Mr. Lawson:
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 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); labeling (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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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 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KO32860
Device Name: ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgA ELISA
Indications For Use:
An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Af Rivers for M. Chan
(Division of "On")
Division of Clinical Laboratory Devices
510(k) Number `KU31860
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
§ 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.”