# K191352: binx health io CT/NG Assay

- Pathway: 510(k) (Traditional)
- Applicant: Binx Health, Inc.
- Decided: Aug 8, 2019 after 80 days
- Product code: QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections)
- Device class: 2
- Regulation: 21 CFR 866.3393
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003395 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091730: BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay, Becton, Dickinson & CO (2009) Summary page 3.
- K091724: BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay, Becton, Dickinson & CO (2009) Summary page 3.

## Most influential descendants
- K200533: binx io CT/NG Assay and binx io CT/NG System (2020), 0 descendants of its own

## Indications for use
The binx health io CT/NG Assay, when tested using the binx health io Instrument, is a fully automated, rapid, qualitative test intended for use in point-of-care or clinical laboratory settings for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in female vaginal swab specimens collected either by a clinician or self-collected by a patient in a clinical setting, to aid in the diagnosis of symptomatic or asymptomatic infection in female patients with Chlamydia trachomatis and/or Neisseria gonorrhoeae.

Source page: https://510kreport.com/device/K191352
Methodology: https://510kreport.com/methodology