# K230267: NeuMoDx CT/NG Assay 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Neumodx Molecular, Inc.
- Decided: Dec 22, 2023 after 325 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: 2 generations back to DEN180047 (2019). 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)
- K190515: Aptima Combo 2 Assay (Panther System), Hologic, Inc. (2019) Summary page 5.

## Indications for use
The NeuMoDx CT/NG Assay 2.0, as implemented on the NeuMoDx 96 Molecular System and NeuMoDx 288 Molecular System, is an automated, qualitative test for the direct detection and differentiation of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA as an aid in the diagnosis of chlamydial and gonococcal urogenital disease in symptomatic and asymptomatic individuals. The Assay utilizes real-time Polymerase Chain Reaction (PCR) and may be used to test male and female urine, and self-collected vaginal swab specimens (collected in a clinical setting).

Source page: https://510kreport.com/device/K230267
Methodology: https://510kreport.com/methodology