Boston Biomedica, Inc. Announces 510(K) Clearance of its Lyme Western Blot Test Kit

WEST BRIDGEWATER, Mass. -- Boston Biomedica, Inc. announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its BBI Borrelia burgdorferi IgM and IgG Western Blot Test Kit. The test method separately detects IgM and IgG antibodies to B. burgdorferi, the infectious tickborne bacteria that cause Lyme Disease. The FDA's 510(k) clearance allows the test to be marketed and sold in the U.S. with the label 'For In Vitro Diagnostic Use'.

The 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 a first-line test (enzyme immunoassay or immunofluorescence assay) for B. burgdorferi antibodies. The Western blot method identifies specific antibodies, and according to Centers for Disease Control and Prevention (CDC) guidelines, a supplementary test such as the Western blot should be used to provide additional information following a positive or equivocal result with the first-line Lyme test.

"This is the same test we developed and manufactured at our BBI Biotech Research Lab in the mid-1990s for use in our clinical laboratory," commented Dr. Patricia E. Garrett, BBI's senior vice president for science and technology. "When the clinical laboratory was sold, and our market research indicated a need for a high quality Western blot, we applied to the FDA for clearance using information we had collected in earlier clinical trials."

Kevin Quinlan, president and COO of BBI, said "We had several years of experience manufacturing and using this test in our own laboratory, and are pleased to be able to market it for in vitro diagnostic use. The market for the Lyme Western blot test includes hospital and clinical reference laboratories that our Accurun salespeople currently call on, so we have very cost-effectively added a product for this market."

BBI provides products and services to the diagnostics and life sciences industry to evaluate, monitor, and ensure the quality of infectious disease test results, to improve the preparation of specimens for genomic/proteomic testing, and to safely store and retrieve rare and valuable biological specimens.

Source: Boston Biomedica, Inc.

Hide comments

Comments

  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Publish