510(k) · Cleared

Cleared

Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit

K190441510(k) TraditionalCleared May 23, 201987-day reviewClass II21 CFR 866.3393

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cepheid · QEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections

Cleared on May 23, 2019 as substantially equivalent to DEN180047 (Hologic, Inc., 2019) and 2 other predicates after an 87-day review. Its family tree reaches back 4 generations to 1996.

Decided: May 23, 2019
Review: 87 days
Class: Class II
Product code: QEP
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to P950039 (1996). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backP950039 Thinprep (R) Processor, Model TP 2000Hologic, Inc. · 1996
3 generations backK043224 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005
2 generations backK121710 Xpert CT/NGCepheid · 2012 · Recalled
1 generation backK173840 Xpert CT/NGCepheid · 2018
This deviceK190441 Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and…Cepheid · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	P950039	Thinprep (R) Processor, Model TP 2000	Hologic, Inc.	1996	—
−3	K043224	Gen-Probe Aptima Combo 2 Assay	Gen-Probe, Inc.	2005	—
−2	K121710	Xpert CT/NG	Cepheid	2012	3
−1	K173840	Xpert CT/NG	Cepheid	2018	—
0 (this device)	K190441	Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert…	Cepheid	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2005	1	0
2019	1	0

FIG. 1 — Lineage of K190441, 1996–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QEP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QEP device

#1 K260917 cobas CT/NG for use on the cobas…score 13.7 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN180047	Aptima Mycoplasma genitalium Assay Summary page 3 …Microbiology (83) Panel Prescription Use Yes Predicate Device – Aptima Mycoplasma genitalium Assay Assay: [De Novo #DEN180047] Predicate Devices – Xpert Vaginal/Endocervical Specimen Collection Kit Ancillary Specimen [510(k) #K173840] Coll…	Hologic, Inc.	2019	—
*	K173840	Xpert CT/NG Summary page 3 …m Assay Assay: [De Novo #DEN180047] Predicate Devices – Xpert Vaginal/Endocervical Specimen Collection Kit Ancillary Specimen [510(k) #K173840] Collection Kits: BD MAX UVE Specimen Collection Kit [510(k) #K043144]…	Cepheid	2018	—
*	K043144	Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Summary page 3 …tion Kit Ancillary Specimen [510(k) #K173840] Collection Kits: BD MAX UVE Specimen Collection Kit [510(k) #K043144] Xpert CT/NG 510(k) Page 1…	Gen-Probe, Inc.	2005	—

Also cleared against DEN180047: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
2 of the 8 ancestors have a recall of any class.
3 other devices also cite its predicate DEN180047.

How does its category compare?

All QEP devices

QEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · QEP

4in 2025

2007high 5 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEP

268in 2025

2007high 521 (2021) · low 46 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QEP

3in 2024

2007high 3 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QEP

9in 2025

2007high 9 (2025) · low 0 (2007)2025

MAUDE reports naming product code QEP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	5	85	0	0
2020	3	46	0	0
2021	3	521	0	1
2022	3	438	0	1
2023	3	325	0	8
2024	0	—	3	8
2025	4	268	0	9
2026	3	171	0	—

What is it indicated for?

The Xpert® CT/NG test, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) to aid in the diagnosis of chlamydial and gonorrheal disease in the urogenital tract and extragenital sites (pharynx and rectum). The assay may be used to test the following specimens from asymptomatic and symptomatic individuals: female and male urine, patient-collected vaginal swabs (collected in a clinical setting), clinician-collected endocervical swabs, and female and male pharyngeal and rectal swabs.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K190441 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190441: Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190441

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026