510(k) · Cleared
ClearedXpert CT/NG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · LSL Dna-Reagents, Neisseria
Cleared on Mar 16, 2018 as substantially equivalent to K121710 (Cepheid, 2012) after an 88-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Mar 16, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- LSL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P950039 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP950039 Thinprep (R) Processor, Model TP 2000Hologic, Inc. · 1996
- 2 generations backK043224 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005
- 1 generation backK121710 Xpert CT/NGCepheid · 2012 · Recalled
- This deviceK173840 Xpert CT/NGCepheid · 2018
- Descendant · cites it directly · 0 of its ownK190441 Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and…Cepheid · 2019
Most influential descendants
Showing 1 of 1 · See all- K190441Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80…Cepheid · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P950039 | Thinprep (R) Processor, Model TP 2000 | Hologic, Inc. | 1996 | — |
| −2 | K043224 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2005 | — |
| −1 | K121710 | Xpert CT/NG | Cepheid | 2012 | 3 |
| 0 (this device) | K173840 | Xpert CT/NG | Cepheid | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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 LSL? 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 LSL device
- #1 K231329 Aptima Neisseria gonorrhoeae Assayscore 6.7 · 1 generation · no Class I recall
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K121710 | Xpert CT/NGSummary page 4…ion Microbiology (83) Advisory Panel Prescription Use Yes Predicate Device: Xpert® CT/NG [510(k) #K121710] Xpert CT/NG 510(k) Page 1 Device Description: The Xp… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190441 | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80… | 2019 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K190441 (Cepheid, 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121710.
How does its category compare?
All LSL devicesLSL Dna-Reagents, Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LSL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LSL
90in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LSL
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSL
41in 2025
MAUDE reports naming product code LSL, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 62 | 0 | 4 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 3 | 86 | 0 | 4 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 1 | — | 1 | 10 |
| 2018 | 3 | 90 | 0 | 7 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Xpert CT/NG Assay, 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 urogenital disease. The assay may be used to test the following specimens from asymptomatic and symptomatic individuals: female and male urine, endocervical…
Read the full statement (193 words)
The Xpert CT/NG Assay, 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 urogenital disease. The assay may be used to test the following specimens from asymptomatic and symptomatic individuals: female and male urine, endocervical swab, and patient-collected vaginal swab (collected in a clinical setting).
Ancillary Collection Kits:
Xpert Vaginal/Endocervical Specimen Collection Kit
The Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.
Xpert Urine Specimen Collection Kit
The Cepheid Xpert Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173840: Xpert CT/NG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173840
Report an extraction error
Are you the manufacturer?
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