BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG

K032713 · Boston Biomedica, Inc. · LSR · Nov 24, 2003 · Microbiology

Device Facts

• Record ID: K032713
• Device Name: BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
• Applicant: Boston Biomedica, Inc.
• Product Code: LSR · Microbiology
• Decision Date: Nov 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

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. 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 (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. The BBI B. burgdorferi IgM Western Blot is especially useful for detection of the acute stage of B. burgdorferi infection. The BBI Borrelia burgdorferi IgG Western Blot is especially useful after the acute phase of B. burgdorferi infection, which is usually a month or more from onset of symptoms. After this early period, seroconversion usually occurs and infected patients are found to be Western blot positive for IgG. Often the onset of infection or symptoms is unknown, and therefore it is recommended that the BBI Borrelia burgdorferi IgM and IgG Western Blots be used together for optimal patient care.

Device Story

The BBI Borrelia burgdorferi IgM and IgG Western Blot Test Kit is an in vitro diagnostic assay. It utilizes human serum samples that have previously screened positive or equivocal via EIA or IFA. The device employs Western blot technology to detect specific IgM and IgG antibodies to B. burgdorferi. The kit includes reagents, controls, test strips, blot reading guides, and report forms. It is intended for laboratory use to provide supportive evidence of Lyme disease infection. Healthcare providers interpret the presence of specific bands on the test strips to confirm the presence of antibodies, aiding in the clinical diagnosis of Lyme disease.

Clinical Evidence

Evaluated using culture-positive samples, IgG EIA positive samples, CDC Lyme panel, commercial Lyme positive panel (PTL202), random blood donors from endemic/non-endemic regions, and samples from patients with cross-reactive conditions (syphilis, rheumatoid arthritis, systemic lupus erythematosus). Performance compared against the predicate device.

Technological Characteristics

Western blot assay. Qualitative detection of antibodies to specific B. burgdorferi protein bands. Uses alkaline phosphatase-conjugated anti-human IgM/IgG and substrate for colorimetric visualization of bound antibodies. Manual test procedure.

Indications for Use

Indicated for the qualitative detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum samples previously testing positive or equivocal by EIA or IFA. Used as supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease.

Regulatory Classification

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), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Predicate Devices

• MarDx Lyme Disease (IgG) Marblot Strip Test System (K950829)

Submission Summary (Full Text)

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| Boston Biomedica, Inc. | NOV 2 4 2003 |
|------------------------|--------------|
|------------------------|--------------|

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 Street<br>West Bridgewater, MA 02379 |
| Contact person: | Patricia E. Garrett, Ph.D. |
| Phone number: | [phone] ext. 111 |
| Fax number: | [phone] |
| E-mail: | [e-mail] |
| Alternate Contact: | Inderjit Kaushal, M.S. |
| Phone number: | 301-208-8100 ext. 169 |
| Fax Number: | 301-947-0795 |
| E-mail: | [e-mail] |
| Preparation Date: | August 29, 2003 |
| Name of the device: | Boston Biomedica, Inc. <i>Borrelia Burgdorferi</i> IgM and IgG Western Blot Test Kit |
| Common name: | <i>In Vitro</i> Diagnostic test for the detection of IgM and IgG antibodies to <i>Borrelia burgdorferi</i> in human serum. |
| Classification name: | None available |
| Predicate Device: | MarDx Lyme Disease (IgG) Marblot Strip Test System<br>Trinity Biotech, Inc.<br>Carlsbad, CA<br>510(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. [phone] • Fax [phone]

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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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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 [phone]. 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 [phone] or [phone] 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:

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.

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)

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