Who is the manufacturer of XPERT CT/NG?

Cepheid filed the 510(k) submission for XPERT CT/NG (K121710).

What is the FDA product code for XPERT CT/NG?

LSL. It is classified under 21 CFR 866.3390 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for XPERT CT/NG?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like XPERT CT/NG?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

XPERT CT/NG

Q: What are the predicate devices for XPERT CT/NG?

GEN-PROBE® APTIMA® Combo 2 Assay (K043224); Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay (K012351).

K121710 · Cepheid · LSL · Dec 27, 2012 · Microbiology

Device Facts

Record ID	K121710
Device Name	XPERT CT/NG
Applicant	Cepheid
Product Code	LSL · Microbiology
Decision Date	Dec 27, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3390
Device Class	Class 2

Intended Use

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). The Cepheid® Xpert® CT/NG Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic 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 female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

Device Story

The Xpert CT/NG Assay is an automated, qualitative in vitro diagnostic test performed on GeneXpert Instrument Systems (Dx, Infinity-48, Infinity-80). It processes urogenital specimens (urine, endocervical/vaginal swabs) to detect and differentiate Chlamydia trachomatis and Neisseria gonorrhoeae genomic DNA. The system integrates sample purification, nucleic acid amplification, and real-time PCR detection within single-use disposable cartridges. Each cartridge contains reagents for target amplification, a Sample Processing Control (SPC), a Sample Adequacy Control (SAC), and a Probe Check Control (PCC). The instrument uses an ultrasonic horn for cell lysis, a syringe drive for fluid movement, and an I-CORE thermocycler for PCR. Results are generated in approximately 90 minutes and displayed in tabular and graphic formats. The device is used in clinical laboratories to aid in the diagnosis of chlamydial and gonorrheal urogenital disease, providing clinicians with rapid, automated results to inform patient management and treatment decisions.

Clinical Evidence

Clinical performance was evaluated in a multi-site prospective study (n=14,790 tests) comparing the Xpert CT/NG Assay to a Patient Infected Status (PIS) algorithm based on two predicate NAATs. Sensitivity for CT ranged from 96.0% to 99.5% and specificity from 99.1% to 99.8% across specimen types. Sensitivity for NG ranged from 94.4% to 100% and specificity from 99.9% to 100%. Indeterminate rate was 2.81%.

Technological Characteristics

Multiplex real-time PCR assay. Uses single-use disposable cartridges with integrated sample prep and I-CORE® thermocycler. Detects CT genomic DNA (CT1 target) and NG genomic DNA (NG2 and NG4 targets). Includes internal controls: Sample Processing Control (SPC), Sample Adequacy Control (SAC), and Probe Check Control (PCC). System includes instrument, PC, and preloaded software. Operates on GeneXpert Dx, Infinity-48, and Infinity-80 systems.

Indications for Use

Indicated for symptomatic and asymptomatic individuals, including males and females, for the detection and differentiation of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in urine, endocervical swabs, and patient-collected vaginal swabs to aid in the diagnosis of urogenital infections.

Regulatory Classification

Identification

Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.

Predicate Devices

GEN-PROBE® APTIMA® Combo 2 Assay (K043224)
Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay (K012351)

Related Devices

K173840 — Xpert CT/NG · Cepheid · Mar 16, 2018
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 · Cepheid · May 23, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ # K121710 ### 510(k) Summary ## DEC 2 7 2012 :: :: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : As required by 21 CFR Section 807.92(c). Cepheid® . 904 Caribbean Drive Submitted by: | 904 Caribbean Drive Sunnyvale, CA 90489 Phone number: (408) 400-8460 Fax number: (408) 541-6439 | | | |----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Contact: | Kerry J. Flom, Ph.D. | | | Date of Preparation: | December 26, 2012 | | | Device: | | | | Trade name: | Xpert® CT/NG | | | Common name: | Xpert CT/NG Assay | | | Type of Test: | Automated, multiplex real-time polymerase chain reaction (PCR) assay intended for the in vitro qualitative detection and differentiation of DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG). | | | Regulation number/ Classification name: | 866.3120/ Chlamydia serological reagents. 866.3390/ Neisseria spp. direct serological test reagents | | | Product code: | MKZ LSL | | | Classification Advisory Panel | Microbiology (83) | | | Predicate Devices - Assay: | GEN-PROBE® APTIMA® Combo 2 Assay [510(k) #K043224] Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay [510(k) #K012351] | | | Predicate Devices – Ancillary Specimen Collection Kits: | GEN-PROBE® APTIMA® Combo 2 Assay [510(k) #K043244] for use with: GEN-PROBE® APTIMA® Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens GEN-PROBE® APTIMA® Urine Specimen Collection Kit for Male and Female Urine GEN-PROBE® APTIMA® Vaginal Swab Specimen Collection Kit for Male and Female Urine | | {1}------------------------------------------------ #### Device Description: . The Xpert CT/NG Assay is an automated in vitro diagnostic test for qualitative detection 心: and differentiation of DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoege (NG). The assay is performed on the Cepheid GeneXpert Instrument Systems. The GeneXpert Instrument Systems automate and integrate sample purification, nucleic acid amplification, and detection of the target sequences in simple or complex samples using real-time PCR and RT-PCR assays. The systems consist of an instrument, personal computer, and preloaded software for running the tests on collected samples and viewing the results. The system requires the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are selfcontained, cross-contamination between cartridges during the testing process is minimized. The Xpert CT/NG Assay includes reagents for the 5' exonuclease real-time PCR detection and differentiation of CT and NG. Reagents for the detection of a Sample Processing Control (SPC), a Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are also included in the cartridge. The SPC is present to control for adequate processing of the target bacteria and to monitor the presence of inhibitors in the PCR reaction. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human DNA. The PCC verifies reagent rehydration. PCR tube filling in the cartridge, probe integrity, and dye stability. The primers and probes in the Xpert CT/NG Assay detect chromosomal sequences in the bacteria. One target is detected for CT (CT1) and two different targets are detected for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result. The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems, the GeneXpert Infinity-48 System and the GeneXpert Infinity-80 System, have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real-time PCR tests. Each module contains a svringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and detection. The ancillary specimen collection kits for use with the Xpert CT/NG Assay are the Cepheid® Xpert® CT/NG Vaginal/Endocervical Specimen Collection Kit and the Cepheid® Xpert® CTNG Urine Specimen Collection Kit. #### Device Intended Use: #### Xpert CT/NG Assay: 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 {2}------------------------------------------------ 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: The Cepheid® Xpert® CT/NG Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay. The Cepheid Xpert CT/NG Vaginal/Endocervical Specimen Collection Kit has only been cleared for use 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 female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay. #### Substantial Equivalence: The Xpert CT/NG Assay is substantially equivalent to the following predicate assays: - K043224: GEN-PROBE® APTIMA® Combo 2 Assay, Gen-Probe Inc. . - K012351: Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria . gonorrhoeae Amplified DNA Assay, Becton Dickenson & Co. Similarities and differences between the Cepheid Xpert CT/NG Assay and the predicate devices are shown in Table 1. A clinical study at thirty-six collection sites was conducted to compare Xpert CT/NG Assay performance relative to a patient infection status algorithm, based on results from the GEN-PROBE APTIMA Combo 2 Assay and Becton Dickenson ProbeTec ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay tests. {3}------------------------------------------------ | | Device | Predicates | | | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Item | Cepheid Xpert CT/NG Assay | GEN-PROBE® APTIMA® Combo 2 Assay | Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay | | | 510(k) No. | To be assigned | K043224 | K012351 | | | Regulation | 866.3120, 866.3390 | 866.3120, 866.3390 | 866.3120, 866.3390 | | | Product Code | MKZ, LSL | MKZ, LSL | MKZ, LSL | | | Device Class | I, II | I, II | I, II | | | Technology/ Detection | Multiplex real-time polymerase chain reaction (PCR) | Multiplex transcription- mediated amplification (TMA) | Multiplex strand displacement amplification (SDA) | | | Intended Use | An automated, multiplex real-time RT-PCR assay, performed on the GeneXpert Instrument Systems, intended for the in vitro qualitative and differentiation of genomic DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) to aid in the diagnosis of chlamydial 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). | A target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in clinician-collected endocervical, vaginal, and male urethral swab specimens, patient- collected vaginal swab specimens*, and female and male urine specimens. The assay is also intended for use with testing of gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System. The assay may be used to test specimens from | Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co- infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BDProbeTec™ ET CT/GC/AC Reagent Pack). | | | | Device | Predicates | | | | Item | Cepheid Xpert CT/NG Assay | GEN-PROBE® APTIMA® Combo 2 Assay | Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay | | | Indication for Use | Asymptomatic and symptomatic patients | symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease. *Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use. | | | | Assay Targets | DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) | Same | Same | | | Specimen Types | Urine, endocervical swab, and patient- collected vaginal swab | ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) | DNA from Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) | | | CT Analyte Targets | CT genomic DNA | Clinician-collected endocervical, vaginal, and male urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens | Endocervical swabs, male urethral swabs, and urine specimens for females and males | | | NG Analyte Targets | NG genomic DNA | CT ribosomal RNA | CT cryptic plasmid DNA | | | | Device | | Predicates | | | Item | Cepheid Xpert CT/NG Assay | GEN-PROBE® APTIMA® Combo 2 Assay | Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay | | | Collection Kit | Urine collection kit Swab collection kit | Urine collection kit Swab collection kit | Urine collection kit Swab collection kit | | | Technological Principles | RT/PCR | TMA | SDA | | | Nucleic Acid Extraction | Yes | Yes | Yes | | | Sample Extraction | Self-contained and automated after specimen sample elution and two single-dose reagent additions. | Manual | Manual | | | Assay Results | Qualitative | Qualitative | Qualitative | | | Instrument System | Cepheid GeneXpert Instrument Systems | Gen-Probe Leader HC+ luminometer and Gen- Probe Target Capture System | ProbeTec™ ET System | | | Assay Controls | Internal sample processing control (SPC), sample adequacy control (SAC), and probe check control (PCC). External controls available. | The Positive Control, CT / Negative Control, GC and the Positive Control, GC / Negative Control, CT act as controls for the target capture, amplification, and detection steps of the assay. | Amplification Control (AC) | | | Rapid test results | Approximately 90 minutes (1.5 hours) to results. | Approximately 4.5 hours to results. | Approximately 3.5 hours to results. | | | Item | Device : Cepheid Xpert CT/NG Vaginal/Endocervical Specimen Collection Kit | Predicate: GEN-PROBE® APTIMA® Unisex Swab Specimen Collection kit for Endocervical and Male Urethral Swab Specimen | Predicate: GEN-PROBE® APTIMA® Vaginal Swab Specimen Collection kit | | | Description | Contains an individually packaged sterile large cleaning swab (for endocervical samples) and a package containing an individually packaged sterile collection swab (for vaginal and endocervical sampling) and a Xpert CT/NG Swab Transport Reagent tube. The collection swab is placed into the Transport Reagent Tube after swab sampling to stabilize the nucleic acid until sample preparation. | Contains an individually packaged sterile Endocervical cleaning swab and an individually-packaged sterile specimen collection swab that is placed into the Transport Tube after swab sampling and is used to stabilize the nucleic acid until sample preparation. | Contains an individually packaged sterile specimen collection swab that is placed into the Transport Tube after swab sampling and is used to stabilize the nucleic acid until sample preparation. | | Table 1: Comparison of Similarities and Differences of the Xpert CT/NG Assay with the Predicate Devices . · . · {4}------------------------------------------------ . . : : : . . {5}------------------------------------------------ The Ancillary Specimen Collection Kits are substantially equivalent to the following predicate assays: - GEN-PROBE® APTIMA® Unisex Swab Specimen Collection Kit for o Endocervical and Urethral Swab Specimens [in 510(k) #K043144] - GEN-PROBE® APTIMA® Urine Specimen Collection Kit for Male and o Female Urine [in 510(k) #K043144] {6}------------------------------------------------ - GEN-PROBE® APTIMA® Vaginal Swab Specimen Collection Kit for o Male and Female Urine [in 510(k) #K043144] . Similarities and differences between the Cepheid Collection Kits and the predicate Collection devices are shown in Table 2. | Table 2: Comparison of Similarities and Differences of the Xpert CT/NG Collection | |-----------------------------------------------------------------------------------| | Kits with the Predicate Device Collection Kits | | Item | Cepheid Xpert CT/NG Urine Specimen Collection Kit | GEN-PROBE® APTIMA® Urine Specimen Collection kit | |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description | Contains one individually packaged sterile disposable transfer pipette and one Xpert CT/NG Urine Transport Reagent tube. Approximately 7 mL of a first-catch urine specimen is transferred to the Urine Transport Reagent tube to preserve and transport the specimen prior to analysis with the Cepheid Xpert CT/NG Assay. | Contains a disposable transfer pipette for adding approximately 2 mL of urine to a Specimen Transport Tube containing 2.0 mL of Transport Buffer. | {7}------------------------------------------------ #### Non-Clinical Studies: #### Analytical Sensitivity (Limit of Detection) Studies were performed to determine the analytical limit of detection (LoD) of the Xpert CT/NG Assay with purified CT elementary bodies seeded into negative natural human pooled vaginal swab and pooled male urine matrices, and NG cells seeded into negative pooled simulated swab and pooled male urine matrices. #### Pooled Vaginal Swab Matrix Elementary bodies from two CT serovars, ATCC vr885 serovar D and ATCC vr879 serovar H. were purified by centrifugation through a 30% sucrose cushion and titered by enumeration of elementary bodies by transmission electron microscopy. Each serovar was diluted into pooled negative vaginal swab matrix and tested with the Xpert CTNG Assay. Replicates of 20 were evaluated at eight concentrations for CT serovar D and at seven concentrations for CT serovar H and LoDs were estimated by probit analysis. The claimed LoDs were confirmed by analyzing at least 20 replicate samples with elementary bodies diluted to the estimated LoD concentrations. For this study, the claimed LoD is defined as the lowest concentration at which 95% of at least 20 replicates are positive. The claimed LoD for purified CT serovar D elementary bodies in vaginal swab matrix is 84 EB/mL. The claimed LoD for purified CT serovar H elementary bodies in vaginal swab matrix is 161 EB/mL (Table 3). In this study, LoDs for the remaining purified CT serovars (in EB/mL) are A (600), B (6), Ba (1900), C (34), E (6), F (202), G (96), I (21), J (150), K (117), LGV I (31), LGV II (20) and LGV III (210) EB/mL. | Organism | LoD | |---------------------------------|-----| | CT ATCC vr885 serovar D (EB/mL) | 84 | | CT ATCC vr879 serovar H (EB/mL) | 161 | | CT Serovar | | LoD (GC/mL) | |--------------|--|--------------| | CT Serovar D | | $1.0 x 10^3$ | | CT Serovar E | | $1.0 x 10^3$ | Two NG strains (ATCC 19424 and ATCC 49226) were tested. Replicates of 20 were evaluated at six concentrations. The LoD was estimated by probit analysis. The LoD for NG, estimated by probit analysis, is 1.6 CFU/mL in a simulated swab matrix background (Table 4). An additional 30 NG strains were tested in a simulated matrix and the LoD was confirmed by testing replicates of three at or near the LoD. Table 4: LoD of Two NG Strains in Pooled Vaginal Swab Matrix | Organism | LoD | |-----------------------|-----| | NG ATCC19424 (CFU/mL) | 1.5 | | NG ATCC49226 (CFU/mL) | 1.6 | Pooled Male Urine Matrix Xpert CT/NG Assay 510(k) Summary {8}------------------------------------------------ Purified and titered elementary bodies from two CT serovars, ATCC vr885 serovar D and ATCC vr879 serovar H, were each tested in a sample matrix of negative pooled male urine. Replicates of 20 were evaluated at eight concentrations for CT serovar D and at seven concentrations for CT serovar H and LoDs were estimated by probit analysis. The claimed LoDs were confirmed by analyzing at least 20 replicate samples with elementary bodies diluted to the estimated LoD concentrations. For this study, the claimed LoD is defined as the lowest concentration at which 95% of at least 20 replicates are positive. The claimed LoD for purified CT serovar D elementary bodies in male urine matrix is 75 EB/mL. The claimed LoD for purified CT serovar H elementary bodies in male urine matrix is 134 EB/mL (Table 5). In this study, LoDs for the remaining purified CT serovars (in EB/mL) are A (900), B (11), Ba (3037), C (34), E (12), F (151), G (48), I (43), J (112), K (88), LGV I (31), LGV II (40) and LGV III (157). Table 5: LoD of Two CT Serovars in Pooled Male Urine Matrix | Organism | LoD | |---------------------------------|-----| | CT ATCC vr885 serovar D (EB/mL) | 75 | | CT ATCC vr879 serovar H (EB/mL) | 134 | Two NG strains, ATCC 19424 and ATCC 49226, were tested in a sample matrix of negative pooled male urine. Replicates of 20 were evaluated at six concentrations. The LoD was estimated by probit analysis. The LoD for NG, estimated by probit analysis, is 1.2 - 2. 7 CFU/mL in a male urine matrix background (Table 6). LoD for 30 additional NG strains was confirmed by testing replicates of three at or near the LoD. | Organism | LoD | |-----------------------|-----| | NG ATCC19424 (CFU/mL) | 2.7 | | NG ATCC49226 (CFU/mL) | 1.2 | #### Table 6: LoD of Two NG Strains in Pooled Male Urine Matrix #### Analytical Specificity (Cross-reactivity) One hundred and one (101) different microorganisms were tested at a concentration of at least 106 CFU/mL or 10 genome copies/mL in replicates of three (Table 7). All isolates were reported CT NOT DETECTED:NG NOT DETECTED; none of the organisms were detected by the Xpert CT/NG Assay. Positive and negative controls were included in the study. The analytical specificity was 100%. | Table 7: Analytical Specificity Determination for Xpert CT/NG Assay | | | | | | |---------------------------------------------------------------------|--|--|--|--|--| |---------------------------------------------------------------------|--|--|--|--|--| | Acinetobacter calcoaceticus | Herpes simplex virus I' | Neisseria sicca (3) | |-----------------------------|--------------------------|------------------------| | Acinetobacter Iwoffi | Herpes simplex virus II' | Neisseria subflava (2) | {9}------------------------------------------------ | Aerococcus viridans | Human papilloma virus1 | Paracoccus denitrificans | |---------------------------------|--------------------------------|-------------------------------| | Aeromonas hydrophila | Kingella denitrificans | Peptostreptococcus anaerobius | | Alcaligenes faecalis | Kingella kingae | Plesiomonas shigelloides | | Arcanobacterium pyogenes | Klebsiella oxytoca | Propionibacterium acnes | | Bacteriodes fragilis | Klebsiella pneumoniae | Proteus mirabilis | | Bifidobacterium adolescentis | Lactobacillus acidophilus | Proteus vulgaris | | Branhamella catarrhalis | Lactobacillus brevis | Providencia stuartii | | Brevibacterium linens | Lactobacillus jensonii | Pseudomonas aeruginosa | | Candida albicans | Lactobacillus lactis | Pseudomonas fluorescens | | Candida glabrata | Legionella pneumophila | Pseudomonas putida | | Candida parapsilosis | Leuconostoc paramensenteroides | Rahnella aquatilis | | Candida tropicalis | Listeria monocytogenes | Saccharomyces cerevisiae | | Chlamydia pneumoniae | Micrococcus luteus | Salmonella minnesota | | Chromobacterium violaceum | Moraxella lacunata | Salmonella typhimurium | | Citrobacter freundii | Moraxella osloensis | Serratia marcescens | | Clostridium perfringens | Morganella morganii | Staphylococcus aureus | | Corynebacterium genitalium | Mycobacterium smegmatis | Staphylococcus epidermidis | | Corynebacterium xerosis | N. meningiditis | Staphylococcus saprophyticus | | Cryptococcus neoformans | N. meningitidis Serogroup A | Streptococcus agalactiae | | Cytomegalovirus1 | N. meningitidis Serogroup B | Streptococcus bovis | | Eikenella corrodens | N. meningitidis Serogroup C | Streptococcus mitis | | Enterococcus avium | N. meningitidis Serogroup D | Streptococcus mutans | | Enterococcus faecalis | N. meningitidis Serogroup W135 | Streptococcus pneumoniae | | Enterococcus faecium | N. meningitidis Serogroup Y | Streptococcus pyogenes | | Enterobacter aerogenes | Neisseria cinerea | Streptococcus salivarius | | Enterobacter cloacae | Neisseria denitrificans | Streptococcus sanguis | | Erysipelothrix rhusiopathiae | Neisseria elongata (3) | Streptococcus griseinus | | Escherichia coli | Neisseria flava | Vibrio parahaemolyticus | | Elizabethkingia meningoseptica2 | Neisseria flavescens (2) | Yersinia enterocolitica | | Fusobacterium nucleatum | Neisseria lactamica (5) | | | Gardnerella vaginalis | Neisseria mucosa (3) | | | Gemella haemolysans | Neisseria perflava | | | Haemophilus influenzae | Neisseria polysaccharea | | . Xpert CT/NG Assay 510(k) Summary . י {10}------------------------------------------------ (n) number of strains tested Tested at 1 x 105 genome copies/mL 2 Previously known as Flavobacterium meningosepticum #### Interfering Substances Performance of the Xpert CT/NG Assay was evaluated in the presence of potentially interfering substances. The evaluated substances were diluted into vaginal/endocervical swab simulated matrix and urine matrix containing either 5x LoD CT serovar D and NG strain ATCC 49226 or x LoD CT serovar H and NG strain ATCC 19424. There was no assay interference in the presence of the substances at the concentrations for vaginal/endocervical matrix (Table 8) and urine matrix (Table 9). | Substance | Concentration | |---------------------------------|-----------------------------------------------------| | Blood | 1.0% v/v | | Mucin | 0.8% w/v | | Seminal Fluid | 5.0% v/v | | Hormones | 7 mg/mL Progesterone + 0.07 mg/mL Beta Estradiol | | LGV II (CT EB) | 106 EB/mL | | Vagisil Anti Itch Cream | 0.25% w/v | | Clotrimazole Vaginal cream | 0.25% w/v | | Preparation H Hemorroidal cream | 0.25% w/v | | Miconazole 3 | 0.25% w/v | | Monistat 1 | 0.25% w/v | | Zovirax Cold Sore Cream | 0.25% w/v | | Vagisil Moisturizer | 0.25% w/v | | Vagi Gard Moisturizing Gel | 0.25% w/v | | KY Jelly Personal Lubricant | 0.25% w/v | Table 8: Potentially Interfering Substances in Swab Matrix {11}------------------------------------------------ | Substance | Concentration | |---------------------------------------------------|---------------| | Yeast Gard Douche | 0.25% w/v | | Delfen Vaginal Contraceptive Foam | 0.25% w/v | | VH Essentials Povidone-Iodine Medicated Douche | 0.25% v/v | | Leukocytes | 106 cells/mL | Table 9: Potentially Interfering Substances in Urine Matrix | Substance | Concentration | |-----------------------------------------------------------------------------|-----------------------------------------------------| | Blood | 0.3% v/v | | Mucin | 0.2% v/v | | Seminal Fluid | 5.0% v/v | | Hormones…

XPERT CT/NG

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