# K081825: BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Dec 11, 2008 after 167 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: 1 generation back to K003395 (2001). 1 ancestor in all.
26 later devices descend from it; 7 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003395: Gen-Probe Aptima Combo 2 Assay, Gen-Probe, Inc. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K098463: BD ProbeTec ET CT/GC Amplified DNA Assay. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K091724: BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay (2009), 13 descendants of its own
- K091730: BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay (2009), 13 descendants of its own
- K110923: Cobas 4800 CT / NG Test (2012), 10 descendants of its own
- K132270: Cobas CT/NG V2.0 Test (2013), 9 descendants of its own
- K163184: cobas® CT/NG v2.0 Test (2017), 7 descendants of its own

## 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 ProbeTec Neisseria gonorrhoeae (GC) QX Amplified DNA Assay, when tested with the BD ViperTM System in extracted mode, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Neisseria gonorrhoeaeDNA in clinician-collected female endocervical and male urethral swabs, patient-collected vaginal swab specimens (in a clinical setting), and female and male urine specimens. The assay is indicated for use with asymptomatic and symptomatic female individuals and symptomatic male individuals to aid in the diagnosis of gonococcal urogenital disease.

Source page: https://510kreport.com/device/K081825
Methodology: https://510kreport.com/methodology