The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Kit is an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples that have been found positive or equivocal using an enzyme immunoassay (EIA) or immunofluorescence assay (FA) test procedure for B. burgdorferi antibodies.

Device Description

The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Test Kit is an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. This device is composed of the reagents, controls and test strips intended for use in Western blot testing of human serum samples for the presence of IgM and/or IgG antibodies to B. burgdorferi. The device is similar in composition to the previously approved BBI Biotech Research Laboratories Borrelia burgdorferi IgM Western Blot Test Kit. The kit also includes Blot Reading Guides, report forms and a Package Insert.

AI/ML Overview

Below is a summary of the acceptance criteria and study information for the Boston Biomedica, Inc. Borrelia burgdorferi IgM and IgG Western Blot Test Kit based on the provided document.

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds. However, it implies that the device's performance was evaluated by comparing it against various sample types and the predicate device, aiming for performance that supports the intended use.

No explicit table of acceptance criteria and reported device performance is provided in the document. The document describes the clinical performance data without numerical targets or direct comparisons in a table format against predetermined criteria.

Study Information

Sample sizes used for the test set and the data provenance:
- Test Set Description: The device was evaluated using:
  - Samples from patients who were culture-positive for B. burgdorferi.
  - Samples that had tested IgG EIA positive.
  - The CDC Lyme panel.
  - A commercially available panel of Lyme positive samples (PTL202).
  - Serum samples from random blood donors from Lyme endemic and non-endemic regions.
  - Samples from patients with ten other infectious diseases and conditions (e.g., syphilis, rheumatoid arthritis, systemic lupus erythematosus).
- Sample Size: The exact sample sizes for each of these categories are not provided in the document.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, beyond mentioning "Lyme endemic and non-endemic regions."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not provide details on the number or qualifications of experts involved in establishing the ground truth for the test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The document does not describe any adjudication method used for the test set.
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:
- No, an MRMC study was not done. This device is an in vitro diagnostic test kit (Western Blot), not an AI-assisted diagnostic tool that would involve human readers and AI assistance in the way a typical MRMC study evaluates. The comparison was primarily between the applicant device and a predicate device, and various clinical sample types.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "device" in this context is a laboratory test kit (Western Blot), which is inherently "standalone" in its technical performance, meaning the chemical and biological reactions produce a result. However, the interpretation of the Western Blot bands to determine a positive or negative result would typically involve a trained laboratory professional. The document does not report on a "standalone" algorithm performance in the way it would for imaging or computational AI. The "summary of clinical performance data" describes the device's accuracy in different clinical scenarios.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth appears to be established using a combination of methods:
  - Culture-positive for B. burgdorferi: This is a definitive microbiological confirmation for Borrelia burgdorferi infection.
  - CDC Lyme panel: This is a characterized panel often used for test validation.
  - Commercially available panel of Lyme positive samples (PTL202): Another characterized panel.
  - IgG EIA positive: This acts as a reference for B. burgdorferi antibody presence, although the Western Blot is intended as a confirmatory test for EIA/IFA positive or equivocal samples.
  - Patient samples from random blood donors from Lyme endemic and non-endemic regions: These serve as healthy controls or general population samples.
  - Samples from patients with other infectious diseases and conditions: Used to assess specificity and cross-reactivity.
The sample size for the training set:
- Not applicable/Not specified. As an in vitro diagnostic kit based on biological reagents, there isn't a "training set" in the context of machine learning or AI algorithms. The kit's design and optimization would have relied on research and development data, but this is not analogous to an algorithm's training set as typically described in AI studies.
How the ground truth for the training set was established:
- Not applicable/Not specified. Given that there is no explicit "training set" in the context of an algorithm, the method for establishing ground truth for such a set is not detailed. The development of the kit's components and interpretation criteria would have been based on established scientific principles and studies on B. burgdorferi antigens and antibody responses.

Summary

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Boston Biomedica, Inc.	NOV 2 4 2003
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510(k) Summary

As required by 21 CFR Section 807.92(a), Boston Biomedica, Inc. is hereby providing a summary of the safety and effectiveness information contained in its 510(k) Notification for the Boston Biomedica, Inc. Borrelia burgdorferi IgM and IgG Western Blot Test Kit.

Submitters name:	Boston Biomedica, Inc.
Address:	375 West StreetWest Bridgewater, MA 02379
Contact person:	Patricia E. Garrett, Ph.D.
Phone number:	(508) 580-1900 ext. 111
Fax number:	(508) 580-1110
E-mail:	pgarrett@bbii.com
Alternate Contact:	Inderjit Kaushal, M.S.
Phone number:	301-208-8100 ext. 169
Fax Number:	301-947-0795
E-mail:	ikaushal@bbii.com
Preparation Date:	August 29, 2003
Name of the device:	Boston Biomedica, Inc. Borrelia Burgdorferi IgM and IgG Western Blot Test Kit
Common name:	In Vitro Diagnostic test for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum.
Classification name:	None available
Predicate Device:	MarDx Lyme Disease (IgG) Marblot Strip Test SystemTrinity Biotech, Inc.Carlsbad, CA510(k) Number: (K950829)

K032713

゜Boston_

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Boston
Biomedica.
Inc.

Description of the device:

The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Test Kit is . an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. This device is composed of the reagents, controls and test strips intended for use in Western blot testing of human serum samples for the presence of IgM and/or IgG antibodies to B. burgdorferi. The device is similar in composition to the previously approved BBI Biotech Research Laboratories Borrelia burgdorferi IgM Western Blot Test Kit. The kit

also includes Blot Reading Guides, report forms and a Package Insert.
Intended use of the device:
The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Test Kit is intended for use in testing human serum samples that have been found positive or equivocal
using an enzyme immunoassay (EIA) or immunofluorescence assay (IFA) test procedure for B. burgdorferi antibodies. Positive results from this Western blot assay are supportive evidence of
infection with B. burgdorferi, the causative agent of Lyme disease

Summary of the technological characteristics of device compared to the predicate devices:

The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Test Kit uses the same Western blot technology as the predicate device. The BBI kit differs from the
Marblot predicate device primarily in the strains of B. burgdorferi that are used, the type of initial antigen preparation, the requirement for a pre-wetting step, the length of incubation times, the standardization of substrate incubation, the method used to identify the bands of interest and the run acceptance criteria. In addition, the BBI Borrelia burgdorferi IgM and IgG Western Blot Test Kit contains all the reagents needed to perform both IgM and IgG
determinations. These differences do not affect the safety or effectiveness of the device.

Summary of the clinical performance data:

The BBI B. burgdorferi IgM and IgG Western Blot Test Kit was evaluated using samples from patients who were culture-positive for B. burgdorferi, samples that had tested IgG EIA positive, the CDC Lyme panel, a commercially available panel of Lyme positive samples (PTL202),
serum samples from random blood donors from Lyme endemic and non-endemic regions, and with samples from patients with ten other infectious diseases and conditions such as syphilis,
rheumatoid arthritis, and systemic lupus erythematosus. The applicant device performance was compared with that of the predicate device for culture-positive samples, EIA positive samples,
and PTL202.
- Prepared by: Patricia E. Garrett, Ph.D.
  - Sr. Vice President, Science and Technology
    - Boston Biomedica, Inc.

375 West Street · W. Bridgewater, MA 02379 Tel. (508) 580-1900 • Fax (508) 580-0250

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble a person with outstretched arms.

NOV 2 4 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Patricia E. Garrett, Ph.D. Senior Vice President, Science and Technology Boston Biomedica, Inc. 375 West Street W Bridgewater, MA 02379

Re: K032713

Trade/Device Name: Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II Product Code: LSR Dated: August 29, 2003 Received: September 4, 2003

Dear Dr. Garrett:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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 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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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): K032713

Device Name: Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Kit

Indications For Use:

Prescription Use × (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 (OIVD)

Luddi In Poole
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

(032713 Page 1 of 1

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).