cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
Applicant
Roche Molecular Systems, Inc.
Product Code
QEP · Microbiology
Decision Date
Jul 8, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 866.3393
Device Class
Class 2
Indications for Use
cobas® CT/NG for use on the cobas® 5800/6800/8800 systems is an automated, qualitative in vitro nucleic acid diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), and clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) swab specimens and anorectal swab specimens all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® Solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals. cobas® TV/MG for use on the cobas® 5800/6800/8800 systems is an automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in male or female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.). cobas® TV/MG also detects TV DNA in cervical specimens collected in PreservCyt® solution and MG DNA in self-collected meatal swab specimens (collected in a clinical setting) and clinician-collected meatal swab specimens. This test is intended as an aid in the diagnosis of TV and MG infections in individuals suspected to have TV or MG infection. A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher sensitivity compared to endocervical swabs and urine. For males, urine is the preferred specimen type due to higher sensitivity compared to meatal swabs. If vaginal swab or male urine is not used and MG testing is negative, further testing with the preferred specimen type may be indicated if M. genitalium infection is strongly suspected.
Device Story
Automated nucleic acid diagnostic tests for detection of CT, NG, TV, and MG DNA; utilizes real-time PCR on cobas 5800/6800/8800 systems. Input: patient specimens (urine, swabs) in cobas PCR Media or PreservCyt. Process: automated extraction/purification using magnetic glass particles; PCR amplification with target-specific primers; real-time detection via fluorescently labeled TaqMan probes. Output: qualitative results (positive/negative/invalid) displayed on system screen or printed report. Used in clinical settings by laboratory personnel. Aids diagnosis of STIs; enables clinical decision-making based on pathogen presence. Modification adds compatibility with Colli-Pee•Dx Urine Collection Kit.
Clinical Evidence
No new clinical data provided; relies on performance characteristics established in previous submissions (K173887, K190433, K202408, K254121).
Technological Characteristics
Automated real-time PCR; TaqMan detection chemistry using FRET; fluorescence-labeled probes; DNA internal control; compatible with cobas 5800/6800/8800 systems; includes Colli-Pee™•Dx Urine Collection Kit.
Indications for Use
Indicated for symptomatic and asymptomatic individuals suspected of having Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, or Mycoplasma genitalium infections. Specimens include urine, vaginal swabs, endocervical swabs, oropharyngeal swabs, anorectal swabs, cervical specimens, and meatal swabs.
Regulatory Classification
Identification
A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) and their associated resistance markers in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data. These devices do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist that are not detected by the device.
Special Controls
A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) must comply with the following special controls: (1) The intended use for the 21 CFR 809.10 labeling must include a detailed description of targets the device detects, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended. (2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device: alternatively, the sample collection device must be cleared in a premarket submission as a part of this device. (3) The 21 CFR 809.10(b) labeling must include: (i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens; (ii) Detailed discussion of the performance characteristics of the device for all claimed specimen types based on analytical studies, including, but not limited to. Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, with-in lab precision, and reproducibility, as appropriate; (iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing. (iv) Limiting statements indicating that: (A)a negative test result does not preclude the possibility of infection; (B) the test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician; (C) reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe procedures in any one of these steps can lead to incorrect results; and (D)if appropriate (e.g., recommended by CDC, by current well-accepted clinical guidelines, or by published peer reviewed research), that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type. (v) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that: (A)negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present; (B) detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora; (C) detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and (D) therapeutic failure or success cannot be determined based on the assay results, since nucleic acid may persist following appropriate antimicrobial therapy. (4) Design verification and validation must include: (i) Detailed device description documentation, including, but not limited to, methodology from obtaining sample to result, design of primer/probe sequences, rationale for target sequence selection, and computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported result). (ii) Detailed documentation of analytical studies including but not limited to, Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, with-in lab precision, and reproducibility, as appropriate. (iii) Detailed documentation and performance results from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan) study report, testing results, and results of all statistical analyses. (iv) A detailed description of the impact of any software, including, but not limited to, software applications and hardware-based devices that incorporate software, on the device's functions.
*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of targets the device detects, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed discussion of the performance characteristics of the device for all claimed specimen types based on analytical studies, including Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate;
(iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) Limiting statements indicating that:
(A) A negative test result does not preclude the possibility of infection;
(B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician;
(C) Reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and
(D) If appropriate (
*e.g.,* recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer reviewed research), that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type; and(v) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that:
(A) Negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present;
(B) Detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora;
(C) Detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and
(D) Therapeutic failure or success cannot be determined based on the assay results, since nucleic acid may persist following appropriate antimicrobial therapy.
(4) Design verification and validation must include:
(i) Detailed device description documentation, including methodology from obtaining sample to result, design of primer/probe sequences, rationale for target sequence selection, and computational path from collected raw data to reported result (
*e.g.,* how collected raw signals are converted into a reported result).(ii) Detailed documentation of analytical studies, including, Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate.
(iii) Detailed documentation and performance results from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan) study report, testing results, and results of all statistical analyses.
(iv) A detailed description of the impact of any software, including software applications and hardware-based devices that incorporate software, on the device's functions.
Predicate Devices
cobas® CT/NG for use on the cobas® 5800/6800/8800 systems (K202408)
cobas® TV/MG for use on the cobas® 5800/6800/8800 Systems (K190433)
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
# **510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT**
# **I Background Information:**
# **A 510(k) Number**
K260917
# **B Applicant**
Roche Molecular Systems, Inc.
# **C Proprietary and Established Names**
cobas CT/NG for use on the cobas 5800/6800/8800 systems
cobas TV/MG for use on the cobas 5800/6800/8800 systems
# **D Regulatory Information**
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QEP | Class II | 21 CFR 866.3393 - Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections | Microbiology |
# **II Submission/Device Overview:**
# **A Purpose for Submission:**
To modify the Warnings and Precautions, and additional materials section in the package inserts of the cobas CT/NG and the cobas TV/MG for use on the 5800/6800/8800 systems to include Colli-Pee•Dx Urine Collection Kit (K254121). No changes were made to the respective cobas assay designs, hardware or software.
# **B Measurand:**
*Chlamydia trachomatis* and *Neisseria gonorrhoeae* DNA
*Trichomonas vaginalis* and *Mycoplasma genitalium* DNA
# **C Type of Test:**
Nucleic acid extraction, purification and amplification assay (real-time polymerase chain reaction)
# **III Intended Use/Indications for Use:**
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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# **A Intended Use(s):**
See Indications for Use below.
# **B Indication(s) for Use:**
*cobas CT/NG for use on the cobas 5800/6800/8800 systems*
cobas CT/NG for use on the cobas 5800/6800/8800 systems is an automated, qualitative in vitro nucleic acid diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of *Chlamydia trachomatis* (CT) and/or *Neisseria gonorrhoeae* (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), and clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) swab specimens and anorectal swab specimens all collected in cobas PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt Solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.
*cobas TV/MG for use on the cobas 5800/6800/8800 systems*
cobas TV/MG for use on the cobas 5800/6800/8800 systems is an automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR), for the direct detection of *Trichomonas vaginalis* (TV) and *Mycoplasma genitalium* (MG) DNA in male or female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical specimens, all collected in cobas PCR Media (Roche Molecular Systems, Inc.). cobas TV/MG also detects TV DNA in cervical specimens collected in PreservCyt solution and MG DNA in self-collected meatal swab specimens (collected in a clinical setting) and clinician-collected meatal swab specimens. This test is intended as an aid in the diagnosis of TV and MG infections in individuals suspected to have TV or MG infection.
A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher sensitivity compared to endocervical swabs and urine. For males, urine is the preferred specimen type due to higher sensitivity compared to meatal swabs. If vaginal swab or male urine is not used and MG testing is negative, further testing with the preferred specimen type may be indicated if *M. genitalium* infection is strongly suspected.
# **C Special Conditions for Use Statement(s)**
Rx - For Prescription Use Only
# **D Special Instrument Requirements:**
cobas 5800/6800/8800 systems
# **IV Device/System Characteristics:**
# **A Device Description:**
*cobas CT/NG for use on the cobas 5800/6800/8800 systems*
The cobas CT/NG for use on the cobas 5800/6800/8800 systems is a fully automated, qualitative real-time PCR assay. cobas CT/NG enables the detection of CT/NG DNA in male and female
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urine, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), and clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) swab specimens and anorectal swab specimens all collected in cobas PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt Solution. The DNA Internal Control, used to monitor the entire sample preparation and PCR amplification process, is introduced into each specimen during sample processing.
# ***cobas TV/MG for use on the cobas 5800/6800/8800 systems***
cobas TV/MG for use on the cobas 5800/6800/8800 systems is an automated, qualitative in vitro nucleic acid diagnostic test for the direct detection of TV/MG DNA in male or female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical specimens collected in cobas PCR Media. cobas TV/MG also detects TV DNA in cervical specimens collected in PreservCyt Solution and MG DNA in self-collected meatal swab specimens (collected in a clinical setting) and clinician-collected meatal swab specimens. The DNA Internal Control, used to monitor the entire sample preparation and PCR amplification process, is introduced into each specimen during sample processing. In addition, the test utilizes external controls (low titer positive control and a negative control).
# **B Principle of Operation:**
# ***cobas CT/NG for use on the cobas 5800/6800/8800 systems***
The cobas CT/NG assay is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas 5800/6800/8800 systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas 5800/6800/8800 software which assigns test results for all tests as positive, negative, or invalid. Results can be reviewed directly on the system screen, exported, or printed as a report.
Nucleic acids from patient specimens and internal control DNA (DNA-IC), added into the specimens to monitor for inhibition of nucleic acid isolation and amplification, are simultaneously extracted. In summary, bacterial nucleic acid is released by addition of proteinase and lysis reagent to the sample. The released nucleic acids bind to the silica surface of added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors, are removed with subsequent wash steps and purified nucleic acids are eluted from the magnetic glass particles with elution buffer at elevated temperature.
Selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers selected from highly conserved plasmid and genomic regions of CT and NG. A region on the CT cryptic plasmid and the *ompA* gene (dual target) and two conserved sequences of the NG DR-9 region are amplified. Selective amplification of DNA-IC is achieved by the use of sequence-specific forward and reverse primers which have no homology with either the CT or NG target regions. A thermostable DNA polymerase enzyme is used for PCR amplification. The target and DNA-IC sequences are amplified simultaneously utilizing a universal PCR amplification profile with predefined temperature steps and number of cycles.
The cobas CT/NG master mix contains two detection probes specific for the CT target sequences, two detection probes specific for the NG target sequences and one for the DNA-IC. The probes are labeled with target specific fluorescent reporter dyes allowing simultaneous
K254121 - Page 3 of 10
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detection of CT targets, NG targets, and DNA-IC in three different channels. When not bound to the target sequence, the fluorescent signal of the intact probes is suppressed by a quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5' to 3' exonuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye increases concomitantly. Real-time detection and discrimination of PCR products is accomplished by measuring the fluorescence of the released reporter dyes for the CT and NG targets and DNA-IC, respectively.
# cobas TV/MG for use on the cobas 5800/6800/8800 systems
cobas TV/MG is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas 5800/6800/8800 systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas 5800/6800/8800 software which assigns test results for all tests as positive, negative, or invalid. Results can be reviewed directly on the system screen, exported, or printed as a report.
Nucleic acid from patient specimens and added internal control DNA (DNA-IC) molecules are simultaneously extracted. In summary, nucleic acid is released by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris, and potential PCR inhibitors are removed with subsequent wash steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature. External controls (positive and negative) are processed in the same way with each cobas TV/MG run.
Selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers for TV and MG which are selected from highly-conserved regions within the respective target organism. TV is detected by one selective set of primers and a probe, while MG is detected by using two sets targeting separate regions (dual-target). Selective amplification of DNA IC is achieved using sequence-specific forward and reverse primers which are selected to have no homology with either the TV or MG target regions. A thermostable DNA polymerase enzyme is used for PCR amplification. The target and DNA-IC sequences are amplified simultaneously utilizing a universal PCR amplification profile with predefined temperature steps and number of cycles. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythymidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA amplicon. Any contaminating amplicon from previous PCR runs is eliminated by the AmpErase enzyme, which is included in the PCR master mix, during the first thermal cycling step. However, newly formed amplicons are not eliminated since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C.
The cobas TV/MG master mix contains one detection probe specific for the TV target sequence, two detection probes specific for the MG target sequences and one for the DNA-IC. The probes are labeled with target specific fluorescent reporter dyes allowing simultaneous detection of TV target, MG target, and DNA-IC in three different channels. When not bound to the target sequence, the fluorescent signal of the intact probes is suppressed by a quencher dye. During the
K254121 - Page 4 of 10
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PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5' to 3' exonuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye increases concomitantly. Real-time detection and discrimination of PCR products is accomplished by measuring the fluorescence of the released reporter dyes for the TV and MG targets and DNA-IC, respectively.
### C Instrument Description Information:
1. Instrument Name:
cobas 5800/6800/8800 systems
2. Specimen Identification:
cobas 5800/6800/8800 analyzer supports multiple types of barcodes. Loaded samples are automatically moved for barcode scanning and processing.
3. Specimen Sampling and Handling:
As per cobas 5800 system or the cobas 6800/8800 systems User Assistance guidance, specimens contained in either primary or secondary sample tubes are loaded into the Sample Supply Module of the cobas 5800/6800/8800 systems for testing. Specimen processing is fully automated.
4. Calibration:
No calibration is required by the user.
5. Quality Control:
See K173887, K202408 and K190433 for quality control information.
### V Substantial Equivalence Information:
A Predicate Device Name(s):
cobas CT/NG for use on the cobas 5800/6800/8800 systems
cobas TV/MG for use on the cobas 5800/6800/8800 systems
B Predicate 510(k) Number(s):
K202408 - cobas CT/NG for use on the cobas 5800/6800/8800 systems
K190433 - cobas TV/MG for use on the cobas 5800/6800/8800 systems
C Comparison with Predicate(s):
A comparison of the cobas CT/NG (K260917) and the cobas CT/NG (K202408) is summarized in Table 1 below.
K254121 - Page 5 of 10
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**Table 1: Comparison with Predicate:**
| Device & Predicate Device(s): | K260917 | K202408 (Predicate) |
| --- | --- | --- |
| Device Trade Name | cobas CT/NG for use on the cobas 5800/6800/8800 systems | cobas CT/NG for use on the cobas 5800/6800/8800 systems |
| Regulation Number | Same | 21 CFR 866.3393 |
| Regulation Name | Same | Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections |
| Regulatory Class | Same | Class II |
| Classification Product Code | Same | QEP |
| Subsequent Product Codes | | MKZ, LSL, OOI |
| Intended Use | Same | cobas CT/NG for use on the cobas 5800/6800/8800 systems is an automated, qualitative in vitro nucleic acid diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of *Chlamydia trachomatis* (CT) and/or *Neisseria gonorrhoeae* (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), and clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) swab specimens and anorectal swab specimens all collected in cobas PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt Solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals. |
| Sample Types | Same | - Male and female urine, - Vaginal swab specimens, - Endocervical swab specimens, - Oropharyngeal (throat) swab specimens, - Anorectal swab specimens, - Cervical specimens in PreservCyt Solution. |
| Subject Status | Same | Symptomatic and asymptomatic |
K254121 - Page 6 of 10
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| Device & Predicate Device(s): | K260917 | K202408 (Predicate) |
| --- | --- | --- |
| Analyte Targets | same | CT cryptic plasmid DNA CT ompA gene NG genomic DNA |
| Sample Preparation | Same | Automated |
| Amplification Technology | Same | Real Time PCR |
| Detection Chemistry | Same | Paired reporter and quencher fluorescence labeled probes (TaqMan Technology) using fluorescence resonance energy transfer (FRET) |
| Controls used | Same | cobas CT/NG Positive Control Kit, cobas Buffer Negative Control Kit |
| Result Analysis | Same | PCR Cycle threshold analysis |
| Collection Devices | Same as predicate with the addition of Colli-Pee•Dx Urine Collection Kit. | cobas PCR Urine Sample Kit, cobas PCR Media Uni Swab Sample Kit, cobas PCR Media Dual Swab Sample Kit, ThinPrep Pap Test Physician's Kits. |
A comparison of the cobas TV/MG (K260917) and the cobas TV/MG (K190433) is summarized in Table 2 below.
**Table 2: Comparison with Predicate:**
| Device & Predicate Device(s): | K260917 | K190433 (Predicate) |
| --- | --- | --- |
| Device Trade Name | cobas TV/MG for use on the cobas 5800/6800/8800 systems | cobas TV/MG for use on the cobas 5800/6800/8800 systems |
| Regulation Numbers | Same | 21 CFR 866.3393 |
| Regulation Names | Same | Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections. |
| Regulatory Class | Same | Class II |
| Classification Product Code | Same | QEP |
K254121 - Page 7 of 10
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| Device & Predicate Device(s): | K260917 | K190433 (Predicate) |
| --- | --- | --- |
| Intended Use | Same | cobas TV/MG for use on the cobas 5800/6800/8800 systems is an automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in male or female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical specimens, all collected in cobas PCR Media (Roche Molecular Systems, Inc.). cobas TV/MG also detects TV DNA in cervical specimens collected in PreservCyt solution and MG DNA in self-collected meatal swab specimens (collected in a clinical setting) and clinician-collected meatal swab specimens. This test is intended as an aid in the diagnosis of TV and MG infections in individuals suspected to have TV or MG infection. A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher sensitivity compared to endocervical swabs and urine. For males, urine is the preferred specimen type due to higher sensitivity compared to meatal swabs. If vaginal swab or male urine is not used and MG testing is negative, further testing with the preferred specimen type may be indicated if M. genitalium infection is strongly suspected. |
| Sample Types | Same | • Male and female urine, • Penile meatal swabs for MG, • Vaginal swab specimens, • Endocervical swab specimens, • Cervical specimens in PreservCyt solution for TV |
| Subject Status | Same | Symptomatic and asymptomatic |
K254121 - Page 8 of 10
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| Device & Predicate Device(s): | K260917 | K190433 (Predicate) |
| --- | --- | --- |
| Analyte Targets | same | 5.8s ribosomal RNA gene (T. vaginalis). MgPar and MgpB genes (M. genitalium). |
| Sample Preparation | Same | Automated |
| Amplification Technology | Same | Real Time PCR |
| Detection Chemistry | Same | Paired reporter and quencher fluorescence labeled probes (TaqMan Technology) using fluorescence resonance energy transfer (FRET) |
| Controls used | Same | cobas TV/MG Positive Control Kit cobas Buffer Negative Control Kit |
| Result Analysis | Same | PCR Cycle threshold analysis |
| | | |
| Collection Devices | Same as predicate with the addition of Colli-Pee•Dx Urine Collection Kit. | cobas PCR Urine Sample Kit, cobas PCR Media Uni Swab Sample Kit, cobas PCR Media Dual Swab Sample Kit, ThinPrep Pap Test Physician's Kits. |
### VI Standards/Guidance Documents Referenced:
None.
### VII Performance Characteristics (if/when applicable):
#### A Analytical Performance:
See K173887, K202408, K190433 and K254121 for analytical performance information.
#### B Comparison Studies:
1. Method Comparison with Predicate Device:
See Clinical Studies section below.
2. Analytical equivalency of Collection Media and Collection Devices:
See K254121 for analytical equivalency information.
#### C Clinical Studies:
See K173887, K202408, K190433 and K254121 for clinical performance information.
#### D Clinical Cut-Off:
Not applicable.
#### E Expected Values/Reference Range:
See K173887, K202408, K190433 and K254121 for expected values/reference range information.
#### F Other Supportive Instrument Performance Characteristics Data:
K254121 - Page 9 of 10
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See K173887, K202408 and K190433 for other supportive instrument performance information.
# **VIII Proposed Labeling:**
The labeling supports the finding of substantial equivalence for these devices.
# **IX Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K254121 - Page 10 of 10
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
