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 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.

AI/ML Overview

This document describes a 510(k) submission for the BBI-Biotech B. burgdorferi IgM Western blot kit. The document lacks detailed acceptance criteria and a dedicated study section with specific performance metrics for the device. Instead, it makes a general claim of "substantial equivalence" based on comparisons with a predicate device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it concludes the device is "substantially equivalent" to a predicate device.

Acceptance Criteria	Reported Device Performance
No explicit numerical acceptance criteria are provided in the document.	The devices were deemed "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."

Study Information

The document describes performance comparisons rather than a standalone study with defined endpoints.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "first physician visit, verified infected patient samples," "randomly selected enzyme immunoassay positive patient samples," "blood samples from random blood donors," and "patients with syphilis antibody, rheumatoid arthritis, and systemic lupus erythematosus." However, the exact number of samples in each category is not quantified.
- Data Provenance: Not explicitly stated (e.g., country of origin). The data appears to be retrospective, as it refers to "verified infected patient samples" and "previously found to be reactive" samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. The document refers to "verified infected patient samples" but does not specify how this verification was performed or by whom.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not mentioned.
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. This device is an in-vitro diagnostic (IVD) kit for laboratory use, not an AI-assisted diagnostic tool that would typically involve human readers in this context.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is an IVD kit, which inherently operates as a "standalone" test performed in a lab setting, where a technician interprets the Western blot bands according to a provided "Blot Reading Guide" and "positive interpretation criterion." The document does not describe a performance study in the manner typically presented for software algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for "verified infected patient samples" is implied but not explicitly defined. For other samples, the ground truth is based on clinical diagnoses (syphilis antibody, rheumatoid arthritis, systemic lupus erythematosus) or donor status (random blood donors). The "first physician visit, verified infected patient samples" suggests a clinical diagnosis of infection.
The sample size for the training set:
- Not mentioned. The document describes a performance comparison study, not a machine learning model requiring a distinct training set.
How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning model is described.

Summary

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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

Intended Use

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 (508) 580-1900 Tel: Fax: (508) 580-0250

Mark M. Manak, Ph.D BBI-Biotech Research Laboratories 217 Perry Parkway Gaithersburg, MD 20877 Tel: (301) 208-8100 (301) 208-8829 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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Page 2

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 of any of

510(k) Number (if known):

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

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 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)

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).