# K121710: Xpert CT/NG - Pathway: 510(k) (Traditional) - Applicant: Cepheid - Decided: Dec 27, 2012 after 199 days - Product code: LSL (Dna-Reagents, Neisseria) - Device class: 2 - Regulation: 21 CFR 866.3390 - Recalls of this device: 3 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to P950039 (1996). 5 ancestors in all. 7 later devices descend from it; 3 cite it directly. 0 of 13 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K043224: Gen-Probe Aptima Combo 2 Assay, Gen-Probe, Inc. (2005) Summary page 1. - K012351: Bdprobetec ET CT/GC Amplified Dna Assay, Becton, Dickinson & CO (2001) Summary page 3. - K043144: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Gen-Probe, Inc. (2005) Summary page 6. ## Most influential descendants - K151565: Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit (2015), 4 descendants of its own - K200748: Visby Medical Sexual Health (2021), 2 descendants of its own - K220407: Visby Medical Sexual Health Test (2023), 1 descendant of its own - K173840: Xpert CT/NG (2018), 1 descendant of its own - K251501: Visby Medical Men's Sexual Health Test (2025), 0 descendants of its own ## Recalls of this device - Oct 9, 2017 · Class II · Z-0592-2018: 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 - Jul 27, 2015 · Class III · Z-2432-2015: 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: 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. ## Indications for use 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?>