(309 days)
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No
The summary describes a laboratory assay for measuring antibodies, which is a standard biochemical test and does not mention any computational or algorithmic components indicative of AI/ML.
No.
The device is an in vitro diagnostic assay used for aiding in the diagnosis of Crohn's disease, not for treating or preventing it.
Yes
The "Intended Use / Indications for Use" section states: "The presence of ASCA may aid in the diagnosis of patients with Crohn's disease." This indicates its use in identifying a disease.
No
The device is an in vitro diagnostic assay, which involves the measurement of antibodies in human serum. This inherently requires physical reagents and laboratory equipment, not just software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- "This assay is intended for the in vitro semi-quantitative measurement...": The phrase "in vitro" explicitly states that the test is performed outside of the living organism, which is a defining characteristic of IVDs.
- "...of ASCA IgA anti-Saccharomyces cerevisiae antibody in human serum.": It specifies that the test analyzes a biological sample (human serum) to detect a specific substance (ASCA IgA antibody).
- "The presence of ASCA may aid in the diagnosis of patients with Crohn's disease.": It describes the intended use of the test in a diagnostic context, specifically to assist in the diagnosis of a disease.
These elements clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
This assay is intended for the in vitro semi-quantitative measurement of ASCA IgA ani-Saccharomyces cerevisiae antibody in human serum. The presence of ASCA may aid in the diagnosis of patients with Crohn's disease. The The prescited of ABOT may ate in the in the clinical findings and other laboratory tests. The ASCA IgA should not be used alone as a screening test for ASCA. ASCA. IgA test should be used to complement, but not to replace or to substitute the ASCA IgG antibody test since some Crohn's disease subgroup patients may not have IgA antibodies.
Product codes
NBT
Device Description
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Mentions image processing
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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
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.”
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and the background is white. The text is centered in the image.
Public Health Service
The Binding Site c/o Mr. Jay Geller West Tower, Suite 4000 2425 West Olympic Blvd. Santa Monica, CA 90404
JUL 2 8 2005
ood and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K042579
Trade/Device Name: Bindazyme Human ASCA IgG EIA Kit Bindazyme Human ASCA IgA EIA Kit Regulation Number: 21 CFR 866.5785 Regulation Name: Anti-Saccharomyces Cerevisiae (ASCA) Test System Regulatory Class: Class II Product Code: NBT Dated: September 20, 2004 Received: September 23, 2004
Dear Mr. Geller:
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 prio 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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Page 2 -
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,
lobatz Beckerh
Robert L. Becker, Jr., MD, Pa. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K042579
Device Name: Bindazyme Human ASCA IgA EIA Kit
Indications for Use: This assay is intended for the in vitro semi-quantitative measurement of ASCA IgA ani-Saccharomyces cerevisiae antibody in human serum. The presence of ASCA may aid in the diagnosis of patients with Crohn's disease. The The prescited of ABOT may ate in the in the clinical findings and other laboratory tests. The ASCA IgA should not be used alone as a screening test for ASCA. ASCA. IgA test should be used to complement, but not to replace or to substitute the ASCA IgG antibody test since some Crohn's disease subgroup patients may not have IgA antibodies.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | ✓ |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of a
Attachment H2
Maue Chan
Division Sign-Off
e of in Vitro Dlagm e Evaluation and Se
510(k) K042579
3
Indications for Use
510(k) Number (if known): K042579
Device Name: Bindazyme Human ASCA IgA EIA Kit
Indications for Use: This assay is intended for the in vitro semi-quantitative measurement of ASCA IgA anti-Saccharomyces cerevisiae antibody in human serum. The presence of ASCA may aid in the diagnosis of patients with Crohn's disease. The test results should be used in conjunction with clinical findings and other laboratory tests. The ASCA IgA should not be used alone as a screening test for ASCA. ASCA IgA test should be used to complement, but not to replace or to substitute the ASCA IgG antibody test since some Crohn's disease subgroup patients may not have IgA antibodies.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | |
|---|---|
| ------------------------------------------------- | -- |
AND/OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of a
Attachment H2
Maria Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042879