Gonospot DNA Probe Culture Confirmation Test

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K872628 ↗

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 Gonospot DNA Probe Culture Confirmation Test used for?

  It is intended for use in microbiology laboratory settings to confirm the presence of Neisseria gonorrhoeae in cultured specimens, serving as a DNA-reagent device for Neisseria identification.

• How is the Gonospot DNA Probe Culture Confirmation Test supplied and what is required for its use?

  The device is supplied as an in vitro diagnostic test and requires laboratory instrumentation and trained personnel for use, as it is not a point-of-care or self-administered test.

• Is the Gonospot DNA Probe Culture Confirmation Test sterile or implantable?

  The device is not sterile and not implantable, as explicitly stated in the device description, which confirms these characteristics for safety and handling clarity.

• What regulatory pathway was used for the Gonospot DNA Probe Culture Confirmation Test?

  The device received FDA 510(k) clearance (K872628) on December 21, 1987, and is regulated as a Class II device with special controls, based on substantial equivalence to a legally marketed predicate.