(83 days)
Not Found
No
The summary describes a standard in vitro diagnostic Western blot assay kit, which relies on biochemical reactions and visual interpretation, not AI/ML algorithms. There is no mention of AI, ML, image processing, or any computational analysis beyond standard laboratory procedures.
No
The device is an in vitro diagnostic assay used to detect antibodies for diagnostic purposes, not to treat or alleviate a disease or condition.
Yes
The device is an in vitro qualitative assay for the detection of antibodies to Borrelia burgdorferi in human serum, intended for use in testing samples that have been found positive or equivocal by other methods, which directly aids in the diagnosis of Borrelia burgdorferi infection (Lyme disease).
No
The device description explicitly states it is a "Test Kit" composed of "reagents, controls and test strips," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is an "in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum." The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of the living organism.
- Device Description: The "Device Description" also reiterates that it is an "in vitro qualitative assay" and describes it as being composed of reagents, controls, and test strips for use in testing human serum samples.
- Testing of Human Samples: The device is designed to test human serum samples, which is a key characteristic of IVDs used for diagnostic purposes.
Therefore, based on the provided text, the Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Kit clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 (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.
Product codes
LSR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
| 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 |
| West 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 System |
| Trinity Biotech, Inc. | |
| Carlsbad, CA | |
| 510(k) Number: (K950829) |
゜Boston_
1
- 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.
- Sr. Vice President, Science and Technology
- Prepared by: Patricia E. Garrett, Ph.D.
375 West Street · W. Bridgewater, MA 02379 Tel. (508) 580-1900 • Fax (508) 580-0250
2
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
4
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)
Luddi In Poole
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Office of In Vitro Diagnostic Device Evaluation and Safety
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