DevicePMAs@therightstef:P910065_S004 JSONTXT

Annnotations TAB JSON ListView MergeView

{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P910065_S004","sourcedb":"DevicePMAs@therightstef","sourceid":"P910065_S004","text":"Approval for design changes to include reduction of the incubation time from 40 to 10 minutes, change in the conjugate diluent, decrease in alp activity and change in packaging size from 200 tests to 100 tests per box. The device, as modified, will be marketed under the trade name st aia-pack pa and is indicated for: st aia-pack pa is designed for in vitro diagnostic use only for the quantitative measurement of prostate specific antigen (psa) in human serum on tosoh aia nex*ia and tosoh aia-600 ii analyzers. This device is indicated for the measurement of serum psa in conjunction with digital rectal examination (dre) as an aid in the detection of prostate cancer (cap) in men fifty years of age and older. Prostate biopsy is required for the diagnosis of cancer. The device is further indicated for the serial measurement of psa in human serum to be used as an aid in the management of patients with prostatic cancer.","tracks":[{"project":"PMA_MER","denotations":[{"id":"T1","span":{"begin":0,"end":8},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25425"},{"id":"T2","span":{"begin":13,"end":19},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C43358"},{"id":"T3","span":{"begin":31,"end":38},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C74521"},{"id":"T4","span":{"begin":39,"end":48},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C157203"},{"id":"T5","span":{"begin":67,"end":71},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25207"},{"id":"T6","span":{"begin":95,"end":101},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25446"},{"id":"T7","span":{"begin":109,"end":118},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61533"},{"id":"T8","span":{"begin":144,"end":152},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C43431"},{"id":"T9","span":{"begin":157,"end":163},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25446"},{"id":"T10","span":{"begin":177,"end":181},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25681"},{"id":"T11","span":{"begin":211,"end":214},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C65039"},{"id":"T12","span":{"begin":225,"end":231},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T13","span":{"begin":279,"end":283},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42614"},{"id":"T14","span":{"begin":362,"end":372},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25482"},{"id":"T15","span":{"begin":373,"end":376},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T16","span":{"begin":403,"end":414},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25209"},{"id":"T17","span":{"begin":436,"end":443},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C268"},{"id":"T18","span":{"begin":453,"end":458},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14225"},{"id":"T19","span":{"begin":459,"end":464},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13325"},{"id":"T20","span":{"begin":523,"end":529},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T21","span":{"begin":551,"end":562},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25209"},{"id":"T22","span":{"begin":566,"end":571},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13325"},{"id":"T23","span":{"begin":579,"end":590},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C79874"},{"id":"T24","span":{"begin":596,"end":603},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62251"},{"id":"T25","span":{"begin":596,"end":622},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17631"},{"id":"T26","span":{"begin":604,"end":610},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25224"},{"id":"T27","span":{"begin":611,"end":622},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C131902"},{"id":"T28","span":{"begin":646,"end":655},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16210"},{"id":"T29","span":{"begin":688,"end":693},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C105785"},{"id":"T30","span":{"begin":703,"end":706},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25150"},{"id":"T31","span":{"begin":728,"end":734},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15189"},{"id":"T32","span":{"begin":755,"end":764},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15220"},{"id":"T33","span":{"begin":781,"end":787},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T34","span":{"begin":824,"end":835},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25209"},{"id":"T35","span":{"begin":846,"end":851},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14225"},{"id":"T36","span":{"begin":852,"end":857},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13325"},{"id":"T37","span":{"begin":886,"end":896},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61372"},{"id":"T38","span":{"begin":914,"end":923},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C27959"}],"attributes":[{"subj":"T1","pred":"source","obj":"PMA_MER"},{"subj":"T2","pred":"source","obj":"PMA_MER"},{"subj":"T3","pred":"source","obj":"PMA_MER"},{"subj":"T4","pred":"source","obj":"PMA_MER"},{"subj":"T5","pred":"source","obj":"PMA_MER"},{"subj":"T6","pred":"source","obj":"PMA_MER"},{"subj":"T7","pred":"source","obj":"PMA_MER"},{"subj":"T8","pred":"source","obj":"PMA_MER"},{"subj":"T9","pred":"source","obj":"PMA_MER"},{"subj":"T10","pred":"source","obj":"PMA_MER"},{"subj":"T11","pred":"source","obj":"PMA_MER"},{"subj":"T12","pred":"source","obj":"PMA_MER"},{"subj":"T13","pred":"source","obj":"PMA_MER"},{"subj":"T14","pred":"source","obj":"PMA_MER"},{"subj":"T15","pred":"source","obj":"PMA_MER"},{"subj":"T16","pred":"source","obj":"PMA_MER"},{"subj":"T17","pred":"source","obj":"PMA_MER"},{"subj":"T18","pred":"source","obj":"PMA_MER"},{"subj":"T19","pred":"source","obj":"PMA_MER"},{"subj":"T20","pred":"source","obj":"PMA_MER"},{"subj":"T21","pred":"source","obj":"PMA_MER"},{"subj":"T22","pred":"source","obj":"PMA_MER"},{"subj":"T23","pred":"source","obj":"PMA_MER"},{"subj":"T24","pred":"source","obj":"PMA_MER"},{"subj":"T25","pred":"source","obj":"PMA_MER"},{"subj":"T26","pred":"source","obj":"PMA_MER"},{"subj":"T27","pred":"source","obj":"PMA_MER"},{"subj":"T28","pred":"source","obj":"PMA_MER"},{"subj":"T29","pred":"source","obj":"PMA_MER"},{"subj":"T30","pred":"source","obj":"PMA_MER"},{"subj":"T31","pred":"source","obj":"PMA_MER"},{"subj":"T32","pred":"source","obj":"PMA_MER"},{"subj":"T33","pred":"source","obj":"PMA_MER"},{"subj":"T34","pred":"source","obj":"PMA_MER"},{"subj":"T35","pred":"source","obj":"PMA_MER"},{"subj":"T36","pred":"source","obj":"PMA_MER"},{"subj":"T37","pred":"source","obj":"PMA_MER"},{"subj":"T38","pred":"source","obj":"PMA_MER"}]},{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":688,"end":693},"obj":"age_start"},{"id":"T2","span":{"begin":694,"end":699},"obj":"age_start_unit"},{"id":"T3","span":{"begin":711,"end":716},"obj":"age_end"},{"id":"T4","span":{"begin":688,"end":716},"obj":"age_range"}],"attributes":[{"subj":"T1","pred":"source","obj":"Age_blah"},{"subj":"T2","pred":"source","obj":"Age_blah"},{"subj":"T3","pred":"source","obj":"Age_blah"},{"subj":"T4","pred":"source","obj":"Age_blah"}]},{"project":"PMA_age_indications","denotations":[{"id":"T7","span":{"begin":688,"end":693},"obj":"age_start"},{"id":"T6","span":{"begin":688,"end":716},"obj":"age_range"},{"id":"T8","span":{"begin":694,"end":699},"obj":"age_start_unit"},{"id":"T9","span":{"begin":711,"end":716},"obj":"age_end"}],"attributes":[{"subj":"T7","pred":"source","obj":"PMA_age_indications"},{"subj":"T6","pred":"source","obj":"PMA_age_indications"},{"subj":"T8","pred":"source","obj":"PMA_age_indications"},{"subj":"T9","pred":"source","obj":"PMA_age_indications"}]},{"project":"updated_tagging_age_PMA_annotations","denotations":[{"id":"T6","span":{"begin":688,"end":716},"obj":"age_range"},{"id":"T7","span":{"begin":688,"end":693},"obj":"age_start"},{"id":"T8","span":{"begin":694,"end":699},"obj":"age_start_unit"},{"id":"T9","span":{"begin":711,"end":716},"obj":"age_end"}],"attributes":[{"subj":"T6","pred":"source","obj":"updated_tagging_age_PMA_annotations"},{"subj":"T7","pred":"source","obj":"updated_tagging_age_PMA_annotations"},{"subj":"T8","pred":"source","obj":"updated_tagging_age_PMA_annotations"},{"subj":"T9","pred":"source","obj":"updated_tagging_age_PMA_annotations"}]},{"project":"consensus_PMA_Age_Indications","denotations":[{"id":"T6","span":{"begin":688,"end":716},"obj":"age_range"},{"id":"T7","span":{"begin":688,"end":693},"obj":"age_start"},{"id":"T8","span":{"begin":694,"end":699},"obj":"age_start_unit"},{"id":"T9","span":{"begin":711,"end":716},"obj":"age_end"}],"attributes":[{"subj":"T6","pred":"source","obj":"consensus_PMA_Age_Indications"},{"subj":"T7","pred":"source","obj":"consensus_PMA_Age_Indications"},{"subj":"T8","pred":"source","obj":"consensus_PMA_Age_Indications"},{"subj":"T9","pred":"source","obj":"consensus_PMA_Age_Indications"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"PMA_MER","color":"#ecc193","default":true},{"id":"Age_blah","color":"#a793ec"},{"id":"PMA_age_indications","color":"#98ec93"},{"id":"updated_tagging_age_PMA_annotations","color":"#ec93b2"},{"id":"consensus_PMA_Age_Indications","color":"#93ccec"}]}]}}