# K090827: BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: May 27, 2009 after 62 days
- Product code: LSL (Dna-Reagents, Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003395 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K062440: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091, Gen-Probe, Inc. (2006) Summary page 1.

## Recalls of this device
- Feb 8, 2013 · Class II · Z-1215-2013: Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.

## Indications for use
The BD ProbeTecTM Neisseria gonorrhoeae(GC) QX Amplified DNA Assay, when tested with the BD ViperTM System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeaeDNA 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 PreservCyt® Solution using an aliquot that is removed prior to processing for additional gynecological testing. The assay is indicated for use with asymptomatic and symptomatic females and symptomatic males to aid in the diagnosis of gonococcal urogenital disease. The BD Viper System, when used with the BD ProbeTec amplified nucleic assay(s), is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s).

Source page: https://510kreport.com/device/K090827
Methodology: https://510kreport.com/methodology