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510(k) Data Aggregation
(556 days)
The COBAS AMPLICOR™ CT/NG Test for Neisseria gonorrhoeae is a qualitative in vitro diagnostic test for the detection of Neisseria gonorrhoeae in clinical specimens. The test is intended for use with the COBAS AMPLICOR Analyzer (K964506). The test utilizes polymerase chain reaction (PCR) for the multiplex nucleic acid amplification of Neisseria gonorrhoeae and Chlamydia trachomatis DNA and target-specific probe hybridization capture for the detection of the amplified Neisseria gonorrhoeae DNA in endocervical swab specimens obtained from asymptomatic and symptomatic female patients, urethral swab specimens obtained from symptomatic male patients and urine specimens obtained from asymptomatic and symptomatic male patients. Testing of male urine specimens may only be performed in conjunction with the use of the Internal Control.
The COBAS AMPLICOR CT/NG Test for Neisseria gonorthoeae is a qualitative in vitro test for the detection of N. gonorrhoeae DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence of infection with N. gonorrhoeae. N. gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the COBAS AMPLICOR Analyzer.
The COBAS AMPLICOR CT/NG Test for Neisseria gonorrhoeae is a multiplex in vitro diagnostic test performed on the COBAS AMPLICOR Analyzer. The COBAS AMPLICOR Analyzer automates the amplification, the nucleic acid hybridization, and the colorimetric detection procedures of the Test. The COBAS AMPLICOR CT/NG Test for Neisseria gonorrhoeae also has an Internal Control for the identification of specimens that contain PCR inhibitors.
{
"acceptance_criteria_and_performance_table": {
"title": "Clinical Performance of COBAS AMPLICOR CT/NG Test for Neisseria gonorrhoeae (Internal Control Used)",
"columns": [
{
"header": "Metric",
"data_keys": ["metric"]
},
{
"header": "Female - Asymptomatic CTM",
"data_keys": ["female_asymptomatic_ctm_sensitivity", "female_asymptomatic_ctm_specificity"]
},
{
"header": "Female - Symptomatic CTM",
"data_keys": ["female_symptomatic_ctm_sensitivity", "female_symptomatic_ctm_specificity"]
},
{
"header": "Total for Females",
"data_keys": ["total_female_sensitivity", "total_female_specificity"]
},
{
"header": "Male - Symptomatic CTM",
"data_keys": ["male_symptomatic_ctm_sensitivity", "male_symptomatic_ctm_specificity"]
},
{
"header": "Male - Asymptomatic Urine",
"data_keys": ["male_asymptomatic_urine_sensitivity", "male_asymptomatic_urine_specificity"]
},
{
"header": "Male - Symptomatic Urine",
"data_keys": ["male_symptomatic_urine_sensitivity", "male_symptomatic_urine_specificity"]
},
{
"header": "Total for Males",
"data_keys": ["total_male_sensitivity", "total_male_specificity"]
}
],
"rows": [
{
"metric": "Sensitivity (95% CI)",
"female_asymptomatic_ctm_sensitivity": "98.0% (89.3-99.9)",
"female_symptomatic_ctm_sensitivity": "94.5% (86.6-98.5)",
"total_female_sensitivity": "95.9% (90.8-98.7)",
"male_symptomatic_ctm_sensitivity": "99.4% (97.9-99.9)",
"male_asymptomatic_urine_sensitivity": "75.0% (42.8-94.5)",
"male_symptomatic_urine_sensitivity": "96.0% (93.9-98.1)",
"total_male_sensitivity": "97.3% (96.1-98.5)"
},
{
"metric": "Specificity (95% CI)",
"female_asymptomatic_ctm_specificity": "98.7% (98.1-99.4)",
"female_symptomatic_ctm_specificity": "98.7% (98.0-99.4)",
"total_female_specificity": "98.7% (98.2-99.2)",
"male_symptomatic_ctm_specificity": "96.2% (95.0-97.5)",
"male_asymptomatic_urine_specificity": "99.6% (98.8-99.9)",
"male_symptomatic_urine_specificity": "97.6% (96.6-98.6)",
"total_male_specificity": "97.7% (97.1-98.3)"
}
],
"acceptance_criteria_stated": "The document does not explicitly state numerical acceptance criteria for sensitivity and specificity. However, the FDA's acceptance of the 510(k) submission ([K974342](https://510k.innolitics.com/search/K974342)) implies that the demonstrated clinical performance was deemed satisfactory for substantial equivalence."
},
"study_information": {
"test_set_sample_size": "5442 specimens (after excluding 44 repeatedly inhibitory specimens from an initial 5486)",
"data_provenance": {
"country_of_origin": "Not explicitly stated, but the study was conducted at six geographically diverse sites.",
"retrospective_or_prospective": "Prospective (clinical study conducted at multiple sites)"
},
"number_of_experts_ground_truth": "Not specified for establishing ground truth from culture results.",
"qualifications_of_experts": "Not specified, but the ground truth was established by Neisseria gonorrhoeae culture results, which are considered a 'gold standard'.",
"adjudication_method": "For discrepant results between the device and culture, an 'alternate primer (16S rRNA) PCR test' was used. However, the results of this alternate PCR test were explicitly *not* used to calculate the clinical performance characteristics of the device but were reported for informational purposes only. This indicates a form of reconciliation, but not a full adjudication where the adjudicator's result defines the final ground truth for original performance calculation.",
"mrmc_comparative_effectiveness_study": {
"performed": false,
"effect_size": "N/A"
},
"standalone_performance": true,
"type_of_ground_truth": "Neisseria gonorrhoeae culture results were considered the primary ground truth. For discrepant results, an alternate primer (16S rRNA) PCR test was used for informational purposes.",
"training_set_sample_size": "Not specified in the provided text.",
"training_set_ground_truth_establishment": "Not specified in the provided text."
}
}
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