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Medical Devices / Regulatory Affairs / Submissions and Approvals

FDA Clears Quidel’s AmpliVue Group B Handheld Strep Test

Jan. 3, 2014
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Molecular diagnostic systems maker Quidel has received FDA 510(k) clearance for its handheld AmpliVue Group B Strep test, the company announced Monday.

Aimed primarily at women between 35 and 37 weeks of pregnancy, the non-instrumented assay combines Quidel’s lateral flow technology with the company’s novel isothermal Helicase Dependent Amplification. Such nucleic acid tests are two times as sensitive as their enzyme immunoassay counterparts, the San Diego devicemaker says.

Launched at year’s end, the new assay is the second AmpliVue product to enter the U.S. market in 2013; earlier in the year, Quidel released a C. difficile assay using the same technology platform.

The Group B strep test is also available in Europe. Tests for other infections using the AmpliVue technology are in the pipeline, Quidel says. — Lena Freund

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