{"id":876,"date":"2020-03-25T16:30:06","date_gmt":"2020-03-25T16:30:06","guid":{"rendered":"https:\/\/mycaretests.com\/us\/?page_id=876"},"modified":"2024-02-05T11:48:24","modified_gmt":"2024-02-05T16:48:24","slug":"fda","status":"publish","type":"page","link":"https:\/\/mycaretests.com\/us\/fda\/","title":{"rendered":"FDA-Cleared"},"content":{"rendered":"[vc_row type=”full_width_background” full_screen_row_position=”middle” column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” bg_color=”#0b81bc” scene_position=”center” top_padding=”6%” bottom_padding=”5%” top_padding_tablet=”6%” bottom_padding_tablet=”5%” left_padding_phone=”10%” right_padding_phone=”10%” text_color=”light” text_align=”left” row_border_radius=”none” row_border_radius_applies=”bg” overflow=”visible” overlay_strength=”0.8″ gradient_direction=”left_to_right” enable_shape_divider=”true” shape_divider_color=”#ffffff” shape_divider_position=”bottom” shape_divider_height=”100″ bg_image_animation=”none” shape_type=”tilt_alt”][vc_column column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” left_margin_tablet=”-50″ left_margin_phone=”-50″ column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” column_position=”default” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”2\/3″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid” offset=”vc_col-lg-8 vc_col-md-9 vc_col-xs-12″][vc_column_text css=”.vc_custom_1635278916935{padding-bottom: 5px !important;}”]\n

Quantitative Clozapine Drug Levels<\/h2>\n[\/vc_column_text][vc_column_text]\n

Rapid enough to be of clinical benefit<\/h3>\n[\/vc_column_text][\/vc_column][vc_column column_padding=”no-extra-padding” column_padding_tablet=”padding-4-percent” column_padding_phone=”no-extra-padding” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” column_position=”default” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/4″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid” offset=”vc_col-lg-4 vc_col-md-3 vc_hidden-xs”][\/vc_column][\/vc_row][vc_row type=”full_width_background” full_screen_row_position=”middle” column_margin=”none” equal_height=”yes” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” scene_position=”center” top_padding=”0″ bottom_padding=”6%” text_color=”dark” text_align=”left” row_border_radius=”none” row_border_radius_applies=”bg” overflow=”visible” id=”overview” overlay_strength=”0.3″ gradient_direction=”left_to_right” shape_divider_position=”bottom” bg_image_animation=”none” shape_type=””][vc_column column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” column_position=”default” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”7\/12″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid” offset=”vc_col-lg-7 vc_col-md-9 vc_col-xs-12″][vc_row_inner column_margin=”none” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” bottom_padding=”10″ text_align=”left” row_position=”default” row_position_tablet=”inherit” row_position_phone=”inherit” overflow=”visible” pointer_events=”all”][vc_column_inner column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” overflow=”visible” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid” offset=”vc_col-lg-11 vc_col-md-11 vc_col-xs-12″][split_line_heading animation_type=”line-reveal-by-space” font_style=”h2″ text_color=”#0b81bc” line_reveal_by_space_text_effect=”default” content_alignment=”default” mobile_content_alignment=”inherit” link_target=”_self” text_content=”The Only FDA Cleared Clozapine Test” font_size=”35″][\/split_line_heading][\/vc_column_inner][\/vc_row_inner][vc_row_inner column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” text_align=”left” row_position=”default” row_position_tablet=”inherit” row_position_phone=”inherit” overflow=”visible” pointer_events=”all”][vc_column_inner column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” overflow=”visible” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” enable_animation=”true” animation=”fade-in-from-bottom” animation_easing=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid” offset=”vc_col-lg-11 vc_col-md-11 vc_col-xs-12″][vc_column_text css=”.vc_custom_1635967558765{padding-right: 10% !important;}”]Clozapine is the most effective antipsychotic drug for reducing positive symptoms, hospital admissions, and all-cause mortality in patients with schizophrenia.1\u00a0<\/sup>Saladax\u2019s test offers clozapine blood levels within hours instead of days. Testing is performed on automated analyzers already present in clinical laboratories.[\/vc_column_text][nectar_btn size=”medium” button_style=”see-through” button_color_2=”Accent-Color” color_override=”#000000″ icon_family=”none” url=”https:\/\/mycaretests.com\/us\/product-catalog-documents\/” text=”Clozapine Product Documents” margin_top=”15px” margin_right=”5px”][nectar_btn size=”medium” button_style=”see-through” button_color_2=”Accent-Color” icon_family=”none” url=”#highlights” text=”Assay Highlights” margin_top=”15px” margin_left=”5px” margin_right=”5px”][nectar_btn size=”medium” open_new_tab=”true” button_style=”see-through” button_color_2=”Accent-Color” icon_family=”none” url=”https:\/\/5568226.fs1.hubspotusercontent-na1.net\/hubfs\/5568226\/MyCare%20Psychiatry\/Product%20Catalogs\/MyCare%20Research%20Use%20Only%20US%20Catalog%20-%20OPL%20MULT-009-RUO.pdf” text=”Additional Assays” margin_top=”15px” margin_left=”5px” 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mobile_content_alignment=”inherit” link_target=”_self” text_content=”Intended Use”][\/split_line_heading][\/vc_column_inner][\/vc_row_inner][vc_row_inner column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” text_align=”left” row_position=”default” row_position_tablet=”inherit” row_position_phone=”inherit” overflow=”visible” pointer_events=”all”][vc_column_inner column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” overflow=”visible” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” enable_animation=”true” animation=”fade-in-from-bottom” animation_easing=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid” offset=”vc_col-xs-12″][vc_column_text css=”.vc_custom_1615477577712{padding-right: 10% !important;}”]The MyCare Psychiatry Clozapine Assay Kit is intended for the in vitro quantitative measurement of clozapine in adult human serum using automated clinical chemistry analyzers. Measurements obtained can be used to aid in the management of individuals prescribed clozapine for treatment-resistant schizophrenia. This assay should be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make treatment decisions.[\/vc_column_text][nectar_btn size=”medium” button_style=”see-through” button_color_2=”Accent-Color” color_override=”#000000″ icon_family=”none” url=”#ranges” text=”View Product Performance & Expected Values” margin_top=”15px”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=”full_width_background” full_screen_row_position=”middle” column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” bg_color=”#ffffff” scene_position=”center” top_padding=”6%” bottom_padding=”2%” text_color=”dark” text_align=”left” row_border_radius=”none” row_border_radius_applies=”bg” overflow=”visible” id=”info” disable_element=”yes” enable_gradient=”true” color_overlay=”#ffffff” color_overlay_2=”#f7f7f7″ overlay_strength=”1″ gradient_direction=”top_to_bottom” shape_divider_position=”bottom” bg_image_animation=”none” shape_type=””][vc_column column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”no-extra-padding” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” column_position=”default” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][vc_column_text css=”.vc_custom_1588857504527{margin-bottom: 18px !important;}”]\n

The Only FDA-Cleared Clozapine Test<\/span><\/h2>\n[\/vc_column_text][vc_row_inner equal_height=”yes” content_placement=”top” column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” bottom_padding=”0%” text_align=”left” row_position=”default” row_position_tablet=”inherit” row_position_phone=”inherit” overflow=”visible” pointer_events=”all” css=”.vc_custom_1615475412982{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}”][vc_column_inner column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” overflow=”visible” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/2″ tablet_width_inherit=”default” animation_type=”default” enable_animation=”true” animation=”fade-in-from-left” animation_easing=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][vc_text_separator title=”OVERVIEW” title_align=”separator_align_left” color=”custom” accent_color=”#0b81bc”][vc_column_text]Many clinicians agree that clozapine is effective in treatment resistant schizophrenia; however, it is underutilized because of concerns of its side effects and the inability to have samples tested in a timely fashion. Saladax’s test now offers clozapine blood levels within minutes, not days. Providing clinicians timely insight into their patient’s clozapine treatment along with enhancing the efficiency of lab results.[\/vc_column_text][\/vc_column_inner][vc_column_inner column_padding=”padding-1-percent” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” overflow=”visible” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/2″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][vc_text_separator title=”INTENDED USE” title_align=”separator_align_left” color=”custom” accent_color=”#0b81bc”][vc_column_text]The MyCare Psychiatry Clozapine Assay Kit is intended for the in vitro quantitative measurement of clozapine in adult human serum using automated clinical chemistry analyzers. Measurements obtained can be used to aid in the management of individuals prescribed clozapine for treatment-resistant schizophrenia. This assay should be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make treatment decisions.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=”yes” content_placement=”top” disable_element=”yes” column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” bottom_padding=”0%” top_padding_tablet=”2%” top_padding_phone=”2%” text_align=”left” row_position=”default” row_position_tablet=”inherit” row_position_phone=”inherit” overflow=”visible” pointer_events=”all” css=”.vc_custom_1615476072124{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}”][vc_column_inner column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” overflow=”visible” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” enable_animation=”true” animation=”fade-in-from-left” animation_easing=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][vc_column_text css=”.vc_custom_1588947167394{margin-top: 15px !important;margin-bottom: 15px !important;}”]The APA\u2019s draft guideline on schizophrenia treatment recommends\u00a0 that measuring clozapine blood levels can be useful<\/strong>[\/vc_column_text][vc_column_text]\n