QUANTA LITE LYME IGG ELISA by INOVA DIAGNOSTICS, INC.

The QUANTA Lite™ Lyme B. burgdorferi IgG ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the initial (first-step) qualitative detection of IgG antibodies to B. burgdorferi, the agent of Lyme disease (Lyme borreliosis), in human serum. This ELISA is intended to provide presumptive evidence of the presence of antibodies to B. burgdorferi. Equivocal or positive results should be followed by a standardized second-step supplemental procedure such as Western blot assays. Positive results on a second-step assay can support a clinical diagnosis of Lyme disease. Diagnosis of Lyme disease should be based on history, physical findings, and other laboratory data in addition to anti-B. burgdorferi results. Negative results should not be the sole basis for exclusion of B. burgdorferi infection.

Device Description

enzyme-linked immunosorbent assay (ELISA)

AI/ML Overview

The provided text describes an FDA 510(k) clearance letter for the QUANTA Lite™ Lyme B. burgdorferi IgG ELISA device. However, it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and the comprehensive study that proves the device meets them.

Specifically, the document is an FDA clearance letter, which confirms substantial equivalence to a predicate device, but does not typically include the raw study data, detailed acceptance criteria, or performance metrics in the format you've requested.

Based on the information available in the provided text, here's what can be extracted:

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

The provided text does not contain a table of acceptance criteria or reported device performance metrics such as sensitivity, specificity, accuracy, etc. It only states that the device is "substantially equivalent" to legally marketed predicate devices. To get this information, one would typically need to review the 510(k) summary or the full submission documentation.

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

The document does not specify the sample size used for the test set, nor the data provenance (country of origin, retrospective/prospective).

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)

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

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

The document does not describe any adjudication method for the test set.

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

The device described is an ELISA kit, which is a laboratory test for detecting antibodies. It is not an AI-based diagnostic tool that would typically involve human "readers" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable to this type of device, and no such study is mentioned.

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

This question is also not applicable as the device is an ELISA kit, not an algorithm. Its performance is inherent to the biochemical reaction and detection system, not an AI algorithm.

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

The document mentions that the ELISA is for "initial (first-step) qualitative detection of IgG antibodies to B. burgdorferi" and that "Equivocal or positive results should be followed by a standardized second-step supplemental procedure such as Western blot assays." It also states, "Positive results on a second-step assay can support a clinical diagnosis of Lyme disease. Diagnosis of Lyme disease should be based on history, physical findings, and other laboratory data in addition to anti-B. burgdorferi results."

This implies that the ground truth for Lyme disease diagnosis is complex and multivariate, involving:

Positive results from a second-step supplemental procedure (e.g., Western blot).
Clinical diagnosis based on "history, physical findings, and other laboratory data."

For the ELISA itself, the ground truth would likely be established in relation to these confirmatory tests and clinical diagnoses, indicating the presence or absence of the B. burgdorferi IgG antibodies and ultimately, Lyme disease. The exact method the manufacturer used to establish ground truth for their specific study is not detailed here.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. This type of information is usually associated with machine learning models, which this device is not. For an ELISA kit, the relevant 'training' for its development would involve optimizing reagents and protocols, not a data training set in the AI sense.

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

As there is no "training set" in the AI sense for this ELISA kit, this question is not applicable. The ground truth for developing and validating an ELISA would involve clinical samples with confirmed disease status (as described in point 7), which is part of the overall validation of the test's performance.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 15 1999

Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, CA 92131-1234

Re: K984222 Trade Name: QUANTA Lite™ Lyme B. burgdorferi IgG ELISA Regulatory Class: II Product Code: LSR Dated: February 5, 1999 Received: February 9, 1999

Dear Mr. Myers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K984222

Device Name: QUANTA Lite™ Lyme B. burgdorferi IgG 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)

Woody Dubois

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984222

Prescription Use X
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 866.3830

Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).