# K140448: BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: May 20, 2014 after 88 days
- Product code: LSL (Dna-Reagents, Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003395 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081825: BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay, Becton, Dickinson & CO (2008) Summary page 1.

## Indications for use
The BD ProbeTec Neisseria gonorrhoeae (GC) QX Amplified DNA Assay, when tested with either the BD Viper System in Extracted Mode or the BD Viper LT System, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath Preservative Fluid or PreservCyt Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.

Source page: https://510kreport.com/device/K140448
Methodology: https://510kreport.com/methodology