{"id":"W2107293557","doi":"10.1373/clinchem.2011.165860","title":"The Challenges and Concerns Companies Face Pertaining to the US Food and Drug Administration 510(k) Process for Cardiac Biomarkers","year":2011,"lang":"en","type":"article","venue":"Clinical Chemistry","topic":"Acute Myocardial Infarction Research","field":"Medicine","cited_by":5,"is_retracted":false,"has_abstract":true,"ca_institutions":"Response Biomedical (Canada)","funders":"Roche Diagnostics; Abbott Diagnostics; Siemens; Ortho Clinical Diagnostics; Bio-Rad Laboratories","keywords":"Medicine; Food and drug administration; Acute coronary syndrome; Clearance; Myocardial infarction; Troponin I; Population; Troponin; Medical laboratory; Troponin complex; Appropriate Use Criteria; Roche Diagnostics; Internal medicine; Intensive care medicine; Cardiology; Medical emergency; Pathology; Environmental health","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0736865,0.001348309,0.001183643,0.00243266,0.008727124,0.02450873,0.003652853,0.04523608,0.01084085],"category_scores_gemma":[0.1261127,0.0009388757,0.002392779,0.002986048,0.009130092,0.01549398,0.004368726,0.02681242,0.007645266],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.007466228,"about_ca_system_score_gemma":0.02859933,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.007440399,"about_ca_topic_score_gemma":0.0106736,"domain_scores_codex":[0.9342111,0.01549654,0.004620245,0.004772843,0.03661163,0.004287491],"domain_scores_gemma":[0.828294,0.07584385,0.01575561,0.006777134,0.06084626,0.0124831],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0001692794,0.000274483,0.004019424,0.0003850113,0.0000557328,0.001340355,0.001176443,0.0003960686,0.001617414,0.04301958,0.7956807,0.1518654],"study_design_scores_gemma":[0.00007971361,0.0003335218,0.002980479,0.001042389,0.00006718688,0.001278708,0.002240617,0.0007726392,0.001332616,0.02305745,0.9665654,0.0002492183],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"empirical","genre_scores_codex":[0.002818791,0.006884748,0.003971068,0.9526385,0.00725652,0.0001810044,0.0001341784,0.0003629279,0.02575218],"genre_scores_gemma":[0.03747682,0.01061079,0.01565991,0.9016881,0.01093693,0.0003109905,0.0002772112,0.0002692975,0.02276999],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.0736865,"threshold_uncertainty_score":0.3896961,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1761324870938888,"score_gpt":0.4224519470907159,"score_spread":0.2463194599968271,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}