← Product Code [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR) · K032713 # BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG (K032713) _Boston Biomedica, Inc. · LSR · Nov 24, 2003 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K032713 ## Device Facts - **Applicant:** Boston Biomedica, Inc. - **Product Code:** [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR.md) - **Decision Date:** Nov 24, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3830 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## 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. ## Regulatory 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](/device/K950829.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k032713 B. Analyte: Borrelia burgdorferi IgM & IgG Western Blot Test Kit C. Type of Test: Western Blot Test D. Applicant: Boston Biomedica, Inc. E. Proprietary and Established Names: BBI Borrelia burgdorferi IgM & IgG Western Blot Test Kit F. Regulatory Information: 1. Regulation section: 21 CFR 866.3830; Treponema pallidum treponemal test reagents 2. Classification: Class II 3. Product Code: LSR; Reagent, Borrelia Serological Reagent 4. Panel: Microbiology (83) G. Intended Use: 1. Intended use(s): 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 {1} Page 2 of 4 Borrelia burgdorferi IgM and IgG Western Blots be used together for optimal patient care. 2. Indication(s) 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. 3. Special condition for use statement(s): Not applicable 4. Special instrument Requirements: Not applicable H. Device Description: Patient serum is diluted and incubated with IgM and IgG blot strips to allow antibodies to bind to specific proteins. The strips are then washed to remove non-binding antibody. Bound antibody reacts in the next incubation with either IgM Conjugate containing heterologous anti-Human IgM or IgG Conjugate containing anti-Human IgG, each conjugated to alkaline phosphatase. After removing unbound conjugate, any bound conjugate is visualized by adding a substrate solution that precipitates a dark blue insoluble product at the site of binding. I. Substantial Equivalence Information: 1. Predicate device name(s): MarDx B. burgdorferi IgG Marblot Strip Test System 2. Predicate K number(s): k950829 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Procedure | Qualitative; B. burgdorferi antibodies to specific protein bands. | Qualitative; B. burgdorferi antibodies to specific protein bands. | | Assay | Western blot | Western blot | | Specimen Type | Serum | Serum | | Differences | | | | Item | Device | Predicate | | Not applicable | | | J. Standard/Guidance Document Referenced (if applicable): Not applicable {2} Page 3 of 4 K. Test Principle: Western Blot Test L. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of BBI-Biotech B. burgdorferi IgM Western blot was assessed using a commercially available 15 member panel (Boston Biomedica, PTI-202) consisting of undiluted specimens from patients with evidence of B. burgdorferi exposure. This panel was tested at each laboratory site (2 sites) on separate days, in either two or three runs per site, for a total of eight observations. The percent agreement to the expected interpretation was then calculated for each site and found to be 100%. b. Linearity/assay reportable range: Not applicable c. Traceability (controls, calibrators, or method): Not applicable d. Detection limit: Not applicable e. Analytical specificity: The specificity of the IgG Western blot kit was 99% when used to test random healthy blood donors (99) from a region not endemic for Lyme disease. The specificity was 100% for 105 normals from endemic region. The cross reactivity of the BBI-Biotech B. burgdorferi IgM Western blot was assessed using samples from patients with potentially interfering conditions or infections and with samples from randomly selected healthy donors from non-endemic and endemic Lyme disease regions. No IgG cross reactivity was observed with the samples tested. f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: The Boston Biomedica's B. burgdorferi IgM Western blot device has been cleared under k980351. The following data represent the performance of B. burgdorferi IgG Western Blot Test. Sensitivity: Of 55 patients presenting with culture confirmed B. burgdorferi infection and erythema migrans, 6 (11%) were positive for IgG. When the BBI B. burgdorferi IgG Western Blot was compared to a predicate, 84% agreement between the two devices was observed. Prospective sample study: Randomly selected samples from seventy patients presenting with symptoms of Lyme disease that had tested positive by an EIA have been tested by the IgG device. No other clinical information is available on these donors. The positivity of these samples was found to be 43% (30/70). {3} Page 4 of 4 CDC Panel: The CDC panel consisted of 47 individual donor specimens, 31 of which were confirmed by culture or erythema migrans to be infected with *B. burgdorferi*, 11 of which had clinical histories suggestive of infection, and 5 of which were negative controls. The overall sensitivity was found to be 36% (15/42). The 5 controls tested negative. *B. Matrix comparison:* Not applicable 3. Clinical studies: *a. Clinical sensitivity:* Not applicable *b. Clinical specificity:* Not applicable *c. Other clinical supportive data (when a and b are not applicable):* Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Not applicable M. Conclusion: The Performance characteristics reported here for the device indicate that it is comparable to the other such test kits currently in the market. --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K032713](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K032713) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com