BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA Assay

• • Terminated Z-1215-2013 FDA Class II ·initiated 8 Feb 2013 ·on shared 510(k) K090971

  Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K090971 ↗

FDA Product Code

LSL

Device Class

Class II

Regulation

21 CFR Part 866.3390

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the BD PROBETEC GC QX Amplified DNA Assay used for?

  This assay is designed for the detection of Neisseria gonorrhoeae DNA in clinical specimens. It is an amplified DNA test used in microbiological testing to identify the presence of the bacterium that causes gonorrhea.

• How is the BD PROBETEC GC QX Amplified DNA Assay supplied and what is its format?

  The device is supplied as an in vitro diagnostic reagent in a kit format. It contains the necessary DNA-reagent components for performing the amplified DNA assay and is intended for use in laboratory settings.

• Is the BD PROBETEC GC QX Amplified DNA Assay a single-use or reusable test?

  As an in vitro diagnostic reagent kit, this assay is intended for single-use per test run. The reagents are consumed during the amplification and detection process and are not designed for reuse.

• What regulatory pathway was used for the BD PROBETEC GC QX Amplified DNA Assay?

  The assay received FDA 510(k) clearance under submission number K090971, demonstrating substantial equivalence to a legally marketed predicate device. It is classified as a Class II medical device under regulation 866.3390 for microbiology applications.