BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT

K980351 · Boston Biomedica, Inc. · LSR · Mar 5, 1999 · Microbiology

Device Facts

• Record ID: K980351
• Device Name: BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
• Applicant: Boston Biomedica, Inc.
• Product Code: LSR · Microbiology
• Decision Date: Mar 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

The BBI-Biotech B. burgdorferi IgM Western blot kit is intended to provide supportive evidence of infection with B. burgdorferi by determining the specific protein reactivities of human serum specimens previously found to be reactive on enzyme immunoassay or indirect immunofluorescence screening assays. The kits will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories.

Device Story

In vitro diagnostic Western blot kit for detection of B. burgdorferi IgM antibodies in human serum. Input: human serum samples previously screened as reactive via enzyme immunoassay or indirect immunofluorescence. Process: nitrocellulose strips containing SDS-solubilized and polyacrylamide-separated B. burgdorferi proteins are incubated with patient serum; anti-IgM alkaline phosphatase conjugate and NBT/BCIP substrate are used to visualize specific protein reactivities. Output: visual identification of protein bands on strips compared against a Blot Reading Guide. Used in clinical and public health laboratories by laboratory professionals. Results provide supportive evidence of infection to assist clinicians in diagnosis. Benefits include confirmation of screening results to aid in Lyme disease management.

Clinical Evidence

Performance evaluated using verified infected patient samples and randomly selected enzyme immunoassay positive patient samples. Subject device demonstrated substantial equivalence to predicate. Higher specificity reported compared to predicate when tested against blood samples from random donors and patients with syphilis, rheumatoid arthritis, and systemic lupus erythematosus.

Technological Characteristics

Western blot assay. Components: nitrocellulose strips with SDS-solubilized/polyacrylamide-separated B. burgdorferi proteins, IgM positive/negative controls, anti-IgM alkaline phosphatase conjugate, buffer concentrate, diluent powder, NBT/BCIP substrate. Manual visual interpretation using provided Blot Reading Guide.

Indications for Use

Indicated for supportive evidence of B. burgdorferi infection in human serum specimens previously reactive on enzyme immunoassay or indirect immunofluorescence screening assays. For use by clinical laboratory professionals.

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

• B. burgdorferi (IgM) Marblot Strip Test System (K951709)

Submission Summary (Full Text)

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K980351

## 510(k) SUMMARY

January 28, 1998

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

## Applicant Device

BBI-Biotech Research Laboratories B. burgdorferi IgM Western blot kit Boston Biomedica, Inc. 375 West Street West Bridgewater, MA 02379

#### Predicate Device

B. burgdorferi (IgM) Marblot Strip Test System 510(k) K951709 MarDx Diagnostics, Inc. 5919 Farnsworth Ct. Carlsbad, CA 92008

## Device Description

The device is a collection of cGMP manufactured critical components needed to perform a Western blot test that will detect B. burgdorferi IgM antibody in naturally infected humans. It includes nitrocellulose strips upon which sodium dodecyl sulfate solubilized and polyacrylamide separated B. burgdorferi proteins have been transferred, an IgM Positive Control, a Negative Control, an anti-IgM alkaline phosphatase concentrate, a buffer concentrate, diluent powder, an NBT/BCIP substrate, Blot Reading Guide, Package Insert, and Results Record Forms.

#### Intended Use

The BBI-Biotech B. burgdorferi IgM Western blot kit is intended to provide supportive evidence of infection with B. burgdorferi by determining the specific protein reactivities of human serum specimens previously found to be reactive on enzyme immunoassay or indirect immunofluorescence screening assays. The kits will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories.

#### Technological Comparison with the Predicate Device

Both devices use the same type of technology. They differ primarily in the strains of B. burgdorferi 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 bands of interest, and the positive interpretation criterion.

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## Performance comparisons

The two devices were substantially equivalent when tested with first physician visit, verified infected patient samples and with randomly selected enzyme immunoassay positive patient samples. The Applicant Device claims higher specificity than the Predicate Device with blood samples from random blood donors and from patients with syphilis antibody, rheumatoid arthritis, and systemic lupus erythematosus.

## Prepared by

Patricia E. Garrett, Ph.D Boston Biomedica, Inc. 375 West Street West Bridgewater, MA 02379 [phone] Tel: Fax: [phone]

Mark M. Manak, Ph.D BBI-Biotech Research Laboratories 217 Perry Parkway Gaithersburg, MD 20877 Tel: [phone] [phone] Fax:

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines beneath them that resemble a river or stream.

HAR = 5 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Debra A. Petit Manager, Clinical Trials and Regulatory Affairs Boston Biomedica, Inc. 375 West Street W. Bridgewater, MA 02379

Re: K980351

Trade Name: BBI-Biotech B. burgdorferi IgM Western Blot Kit Regulatory Class: II Product Code: LSR Dated: December 17, 1998 Received: December 21, 1998

Dear Ms. Petit:

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 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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 of any of

510(k) Number (if known):

Device Name: BBI-Biotech Research Laboratories B. burgdorferi IgM Western blot kit -

Indications For Use:

.

The BBI-Biotech B. burgdorferi IgM Western blot kit is intended to provide supportive evidence of infection with B. burgdorferi by determining the specific protein reactivities of human serum specimens previously found to be reactive on enzyme immunoassay or indirect immunofluorescence screening assays. The kits will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Woody Dafars |
|-----------------------------------------|--------------|
| (Division Sign/Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K980351 |

| Prescription Use | X |
|---------------------|---|
| (Per 21 CFR 801.109 | |

OR Over-The-Counter Use

(Optional Format 1-2-96)