The QUANTA Lite™ Lyme B. burgdorferi IgM ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the initial (first-step) qualitative detection of IgM 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. burodorferi. 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. The QUANTA Lite™ Lyme B. burgdorferi IgM ELISA can be used alone during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After the acute phase, infected individuals usually develop anti-B. burgdorferi IgG antibodies and a positive IgM result alone is not recommended for supporting a diagnosis of active Lyme disease in persons with illness of greater than 1 month duration. Negative results should not be the sole basis for exclusion of B. burgdorferi infection.

Device Description

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AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for an in vitro diagnostic device, the QUANTA Lite™ Lyme B. burgdorferi IgM ELISA. This document outlines the regulatory approval process and the intended use of the device but does not contain information on the acceptance criteria or the specific study details that demonstrate the device meets those criteria.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance: This information is not present in the provided text.
Sample sizes used for the test set and data provenance: These details are not included. The letter mentions it's an in vitro diagnostic for human serum, but no specifics on test population characteristics or study design are given.
Number of experts used to establish ground truth and their qualifications: Not applicable/not provided for this type of submission.
Adjudication method: Not applicable/not provided.
MRMC comparative effectiveness study details: Not applicable. This letter is for an ELISA kit, not an AI-assisted diagnostic.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: While the device measures IgM antibodies to B. burgdorferi with subsequent Western blot as a supplemental procedure, the specific method for establishing the ground truth for the FDA submission study is not described.
Sample size for the training set: Not applicable (this is an ELISA kit, not an AI algorithm requiring a training set in the conventional sense).
How ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

Device Name: QUANTA Lite™ Lyme B. burgdorferi IgM ELISA
Regulatory Class: II
Product Code: LSR
Indications for Use: Initial (first-step) qualitative detection of IgM antibodies to B. burgdorferi in human serum, providing presumptive evidence of antibodies. Equivocal or positive results should be followed by a standardized second-step supplemental procedure (e.g., Western blot). Can be used alone during the acute phase (0-4 weeks of symptom onset). Not recommended for diagnosis of active Lyme disease after 1 month if only IgM is positive. Negative results do not exclude infection.

To answer your request, one would need access to the actual 510(k) submission document or a summary of safety and effectiveness, which would contain the clinical study data, statistical analysis, and performance claims. The provided FDA clearance letter is a regulatory approval notice, not the scientific study report itself.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

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: K984234

Trade Name: OUANTA Lite™ Lyme B. burgdorferi IgM 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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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Page of of

510(k) Number (if known): K984234

Device Name: QUANTA Lite™ Lyme B. burgdorferi IgM ELISA

—

Indications For Use:

Woody Dubois

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984234

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use > (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).