QUANTA LITE OMP PLUS ELISA by INOVA DIAGNOSTICS, INC.

The QUANTA Lite™ OMP Plus kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-OMP antibodies of the IgA class in human serum. It is intended to be used in conjunction with anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) IgG and/or IgA test systems. The presence of OMP (outer membrane proteins) IgA antibodies, used in conjunction with clinical findings and other laboratory tests, may aid in the diagnosis of patients with Crohn's disease.

Device Description

Not Found

AI/ML Overview

This is an FDA 510(k) clearance letter for the QUANTA Lite™ OMP Plus IgA ELISA device. This type of document typically focuses on establishing substantial equivalence to a predicate device and does not contain detailed study results or acceptance criteria in the format you've requested for AI/Software as a Medical Device (SaMD).

The information provided describes a laboratory diagnostic test kit for detecting IgA antibodies, not an AI or SaMD product. Therefore, many of the requested categories, such as sample sizes for test sets and training sets, number and qualifications of experts, adjudication methods, MRMC studies, and standalone AI performance, are not applicable to this type of medical device submission and are not present in the provided text.

Based on the document, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

This document does not specify formal acceptance criteria in a table or directly report performance metrics like sensitivity, specificity, or AUC for the device itself. Instead, the FDA's clearance is based on the device being substantially equivalent to a legally marketed predicate device. This implies that the performance characteristics (e.g., precision, accuracy, linearity) would have been assessed during the validation studies submitted to the FDA, and deemed comparable to the predicate. However, these specific metrics and acceptance criteria are not detailed in the clearance letter itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not explicitly stated in this clearance letter. Clinical study details (sample sizes, provenance, study design) are part of the full 510(k) submission, not typically in the clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is a laboratory diagnostic test. Ground truth would be established through clinical diagnosis of Crohn's disease, potentially with a panel of clinical experts, but this information is not in the clearance letter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a laboratory diagnostic test, not an imaging device requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a laboratory diagnostic test, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a laboratory diagnostic test. The "standalone performance" is the performance of the assay kit itself, which would be measured in a lab setting. The clearance letter doesn't detail these study specifics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this type of device (an assay for IgA antibodies against OMP), the ground truth for evaluating its clinical utility would typically be the clinical diagnosis of Crohn's disease, established through a combination of clinical findings, endoscopy, imaging, and potentially other laboratory tests or pathology. However, the specific methodology for establishing this ground truth in the studies supporting the 510(k) is not contained in this letter.

8. The sample size for the training set:

Not applicable. This is a laboratory diagnostic test, not a machine learning model that requires a "training set" in the conventional AI sense. The assay works based on biochemical reactions.

9. How the ground truth for the training set was established:

Not applicable for the same reason as above. The "ground truth" for developing and validating such an assay would involve known positive and negative samples for the target antibodies, often derived from clinically characterized patient populations.

Summary

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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 features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

INOVA Diagnostics, Inc. c/o Gary L. Norman, Ph.D. Senior Scientist 9900 Old Grove Rd San Diego, CA 92131-1638

OCT 2 7 2008

Re: K081248

Trade/Device Name: QUANTA Lite™ OMP Plus IgA ELISA Regulation Number: 21 CFR 866.5785 Regulation Name: Anti-Saccharomyces cerevisiae (S. Cerevisiae) antibody (ASCA) test system Regulatory Class: Class II Product Code: OKM Dated: September 25, 2008 Received: September 25, 2008

Dear Dr. Norman:

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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The

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Page 2 - Gary L. Norman, PhD

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 (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

m. Chen

Maria M. Chan, Ph.D. Acting 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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Indications for Use

510(k) Number (if known): K081248

Device Name:_QUANTA Lite™ OMP Plus ELISA

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (QIVD)

Mana M Chan

of In Vitro Diagnootic e Evaluation and Satery

510(k) K081248

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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.”