QUANTA LITE CCP3.1 IGG/IGA ELISA by INOVA DIAGNOSTICS, INC.

The QUANTA Lite™ CCP3.1 IgG/IgA ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG and IgA anti-CCP3 (Cyclic Citrullinated Peptide 3) antibodies in patient sera or citrated or EDTA plasma. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis (RA), including RA diagnosed within 2 years of presentation of symptoms.

Device Description

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AI/ML Overview

Here's the analysis of the provided text, focusing on the acceptance criteria and the study details for the QUANTA Lite™ CCP 3.1 IgG/IgA ELISA device.

It's important to note that the provided text is an FDA 510(k) clearance letter and an Indications For Use statement. This type of document typically does NOT include the detailed study design, acceptance criteria, or performance data that would be found in the actual 510(k) submission or a scientific publication. The FDA letter confirms substantial equivalence to a predicate device, implying that the device met certain performance expectations, but the specifics of those expectations and the data demonstrating them are not in this document.

Therefore, for most of your requested points, I will have to state that the information is "Not available in the provided text."

Acceptance Criteria and Study Details for QUANTA Lite™ CCP 3.1 IgG/IgA ELISA

Based on the provided FDA 510(k) clearance letter and Indications For Use:

A table of acceptance criteria and the reported device performance
- Not available in the provided text. The FDA clearance letter confirms substantial equivalence but does not detail specific acceptance criteria (e.g., sensitivity, specificity thresholds) or quantitative performance metrics (e.g., specific sensitivity/specificity values, prevalence estimates) from the study. Such data would be in the full 510(k) submission.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available in the provided text.
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 available in the provided text. For an in vitro diagnostic (IVD) like an ELISA, ground truth is typically established by other diagnostic methods (e.g., established clinical criteria for RA, confirmatory serological tests, or clinical follow-up), rather than direct expert interpretation of images or complex data as might be the case for imaging AI. The "experts" would primarily be the clinicians diagnosing RA in the patient cohorts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not available in the provided text. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where multiple readers' opinions need to be reconciled. For an ELISA device, the "reading" is an objective measurement (e.g., optical density value) that is then compared against a cut-off. The clinical diagnosis (ground truth) typically comes from a physician's assessment based on multiple factors, which can implicitly involve a form of clinical "adjudication" based on established diagnostic criteria. The method for establishing this clinical ground truth is not detailed.
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/Not available in the provided text. This device is an in vitro diagnostic (ELISA test) for detecting antibodies, not an AI-based imaging or interpretive device that aids human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of medical device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, this is implicitly a standalone device. An ELISA test is an "algorithm only" in the sense that it provides a quantitative result (e.g., optical density) which is then translated into a qualitative result (e.g., positive/negative) based on a predetermined cut-off. The "human-in-the-loop" aspects involve the laboratory technician performing the test and the clinician interpreting the result in the context of the patient's overall clinical picture, but the device itself generates a result independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in the provided text, but implied to be a clinical diagnosis of Rheumatoid Arthritis (RA). For an in vitro diagnostic aid in the diagnosis of RA, the ground truth would typically be established by a physician using the American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) classification criteria for RA, possibly including long-term clinical follow-up or other accepted diagnostic standards.
The sample size for the training set
- Not available in the provided text.
How the ground truth for the training set was established
- Not available in the provided text. Similar to the test set, it would likely be based on clinical diagnosis of RA using established criteria.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is made up of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 5 2008

c/o Dr. Rufus Burlingame Senior Scientist 9900 Old Grove Rd. San Diego, CA 92131-1638

INOVA Diagnostics, Inc.

Re: K072944

Trade/Device Name: QUANTA Lite™ CCP 3.1 IgG/IgA ELISA Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: Class II Product Code: NHX Dated: February 21, 2008 Received: February 26, 2008

Dear Dr. Burlingame:

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. Iisting 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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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,

Robert Becker/

Robert L. Becker, Jr., M.D., Ph.D. 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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Page 7 of 22

510(k) Number (if known): K072944

Device Name: QUANTA Lite™ CCP3.1 IgG/IgA ELISA

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X_

Over-The-Counter Use

(Per 21 CFR 801.109)

Mana M Chor

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072944

(Optional Format 1-2-96)

Page 7

Regulation Number and Section

§ 866.5775 Rheumatoid factor immunological test system.

(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).