510(k) · Cleared
Recalled · Class II · 2017Xpert 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 Dec 27, 2012 as substantially equivalent to K043224 (Gen-Probe, Inc., 2005) and 2 other predicates after a 199-day review. Its family tree reaches back 2 generations to 1996. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 27, 2012
- Review
- 199 days
- Class
- Class II
- Product code
- LSL
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to P950039 (1996). 5 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backP950039 Thinprep (R) Processor, Model TP 2000Hologic, Inc. · 1996
- 1 generation backK043224 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005
- This deviceK121710 Xpert CT/NGCepheid · 2012
- Descendant · cites it directly · 4 of its ownK151565 Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems…Cepheid · 2015
- Descendant · cites it directly · 2 of its ownK200748 Visby Medical Sexual HealthVisby Medical · 2021
- Descendant · 2 generations on · 1 of its ownK220407 Visby Medical Sexual Health TestVisby Medical · 2023
- Descendant · cites it directly · 1 of its ownK173840 Xpert CT/NGCepheid · 2018
- Descendant · 3 generations on · 0 of its ownK251501 Visby Medical Men's Sexual Health TestVisby Medical, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…Cepheid · 2015 · cites it directly4descendants
- K200748Visby Medical Sexual HealthVisby Medical · 2021 · cites it directly2descendants
- K220407Visby Medical Sexual Health TestVisby Medical · 2023 · 2 generations on1descendant
- K173840Xpert CT/NGCepheid · 2018 · cites it directly1descendant
- K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950039 | Thinprep (R) Processor, Model TP 2000 | Hologic, Inc. | 1996 | — |
| −1 | K043224 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2005 | — |
| 0 (this device) | K121710 | Xpert CT/NG | Cepheid | 2012 | — |
| +1 | K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx… | Cepheid | 2015 | — |
| +1 | K200748 | Visby Medical Sexual Health | Visby Medical | 2021 | — |
| +2 | K220407 | Visby Medical Sexual Health Test | Visby Medical | 2023 | — |
| +1 | K173840 | Xpert CT/NG | Cepheid | 2018 | — |
| +3 | K251501 | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | 2025 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 | Decided |
|---|---|---|---|
| * | K043224 | Gen-Probe Aptima Combo 2 AssaySummary page 1…on Microbiology (83) Advisory Panel Predicate Devices - GEN-PROBEO APT1MA4" Combo 2 Assay [5 10(k) Assay: #K043224] Becton Dickenson ProbeTeCTM ET Chiamydia trachomaris INeis… | 2005 |
| * | K012351 | Bdprobetec ET CT/GC Amplified Dna AssaySummary page 3…lence: The Xpert CT/NO Assay is substantially equivalent to the following predicate assays: " K04 3224: GEN-P ROBE® APTI MA® Combo 2 Assay, Gen-Probe Inc. * K012351: Becton Dickenson ProbeTecTMET Chiatnydia trachoinatis/lNeisseria gonorrhoeae Amplified DNA Assay, Becton Dickenson & Co… | 2001 |
| * | K043144 | Gen-Probe Aptima Assay for Neisseria GonorrhoeaeSummary page 6…owing predicate assays: o GEN-PROBE®APTIMA® Unisex Swab Specimen Co llection Kit for Endocervical and Urethral Swab Specimens [in 5 10(k) #K043 144] o GEN-PROBE® APTIMA® Urine Specimen Collection Kit for Male and Female Urine [in 5 10(k) #K0… | 2005 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 9, 2017 | Class II | Z-0592-2018 | Equipment maintenance | Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. Investigation of the issue… |
| Jul 27, 2015 | Class III | Z-2432-2015 | Incorrect or no expiration date | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date. |
| Jul 27, 2015 | Class III | Z-2431-2015 | Incorrect or no expiration date | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K151565 (Cepheid, 2015) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K043224.
How does its category compare?
All LSL devicesLSL Dna-Reagents, Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 GeneXpertO Instrument Systems, is a qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from Chiamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) to aid in the diagnosis of chiamydlial and gonorrheal urogenital disease. The assay may be used to test the following specimens from asymptomnatic and symptomatic individuals: female and male urine, endlocervical…
Read the full statement (159 words)
The Xpert® CT/NG Assay, performed on the GeneXpertO Instrument Systems, is a qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from Chiamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) to aid in the diagnosis of chiamydlial and gonorrheal urogenital disease. The assay may be used to test the following specimens from asymptomnatic and symptomatic individuals: female and male urine, endlocervical swab, and patient-collected vaginal swab (collected in a clinical setting).
The Cepheid® Xpert® CT/NG Vaginal/Endlocervical Specimen Collection Kit is designed to collect, preserve and transport patient Chiamydia trachonatis and Neisseria gonorrhoeae DNA in endlocervical and vaginal specimens from symptomatic and asymptomnatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay. The Cepheid® Xpert® CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and femnaleurine specimens from symptomatic and asymptomnatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.'} finishhandzu?></numerusform} буниң
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121710: 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/K121710
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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