Abstract: The present disclosure provides methods and systems to collect blood from a patient using a lancet integrated with a test strip. The present disclosure provides integrated test strips having an integrated lancet, as well as meters for actuating the lancet integrated within a test strip. The analyte test strip comprises a first test strip substrate material and a second test strip substrate material. At least one test strip substrate material comprises an elongate cavity. The test strip further comprises a reaction test site for testing analyte concentrations in blood. The test strip further comprises at least one opening communicating with the at least one cavity.

Abstract: The present disclosure provides methods and systems to collect blood from a patient using a lancet integrated with a test strip. The present disclosure provides integrated test strips having an integrated lancet, as well as meters for actuating the lancet integrated within a test strip. The analyte test strip comprises a first test strip substrate material and a second test strip substrate material. At least one test strip substrate material comprises an elongate cavity. The test strip further comprises a reaction test site for testing analyte concentrations in blood. The test strip further comprises at least one opening communicating with the at least one cavity.

Abstract: Methods and devices for determining the concentration of a constituent in a physiological sample are provided. The blood sample is introduced into a test strip with portions of the blood sample being directed to both a first capillary and a second capillary. The first capillary configured to electrochemically determine a concentration of a first analyte in a blood sample by measuring a signal across a set of electrodes. The second capillary is configured to determine a hematocrit value of the blood sample by measuring a signal across a second set of electrodes.

Abstract: A diagnostic test strip is provided. The test strip comprises at least one electrically insulating substrate material and a plurality of electrical strip contacts disposed on the least one insulating substrate layer. The at least one electrical strip contact includes a first conductive layer disposed on the substrate, and a second conductive layer disposed on top of the first conductive layer.

Abstract: A system for diagnostic testing may include a meter for performing a diagnostic test on a sample applied to a test media, the meter having a housing and an interface for receiving a signal representing coding information, and a container configured to contain test media compatible with the meter, the container having a coding element associated therewith. Additionally, the system may provide a mechanisms for removing the meter from an interconnected test container and reattaching it to a new container using on-container coding methods that can recalibrate the meter for the new container of test strips. The system may further provide a sampling device, such as a lancet, operably connected to the container such that that a user may use the sampling device to obtain a sample without disconnecting the sampling device from the container.

Abstract: An auto-calibration system for diagnostic test strips is described for presenting data individually carried on each test strip readable by a diagnostic meter. The carried data may include an embedded code relating to data particular to that individual strip. The data is presented so at to be read by a meter associated with the diagnostic test strip in order to avoid manually inputting the information.

Abstract: A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the sample chamber. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.

Abstract: An auto-calibration system for diagnostic test strips is described for presenting data individually carried on each test strip readable by a diagnostic meter. The carried data may include an embedded code relating to data particular to that individual strip. The data is presented so at to be read by a meter associated with the diagnostic test strip in order to avoid manually inputting the information.

Abstract: A method for manufacturing a diagnostic testing system is provided. Various methods are described for calibrating the test system to work with selected test media compatible with the calibration to provide accurate results. The methods eliminate the need for any kind of user-coding. Packaging only compatible selected diagnostic test media with the calibrated meter can include at least one container for enclosing the diagnostic test media, wherein the container can be physically coupled to the diagnostic meter.

Abstract: A smart interface assembly is provided which enables convenient, instant, and discreet communication between an analytical meter and a computer, the transfer of data from the analytical system, and/or the provision of interface software for the display or analysis of data. The smart interface assembly includes first and second couplings for interfacing with the personal computer and the analytical meter. The smart interface assembly has processing and memory capabilities facilitating displaying test results from an analytical system on a computer. The interface can also function as a storage device allowing transfer, access, or syncing of data from a diagnostic system to or by the personal computer without the need for special drivers, and also can facilitate communications between the diagnostic system and the computer using standard device drivers likely to be already present on the computer.

Abstract: A system for diagnostic testing may include a meter for performing a test on a sample applied to a test media and a selectively closable container configured to house test media compatible with the meter. The system may also provide mechanisms for removing a meter from a test container and reattaching it to a new one using one of several coding methods that recalibrate the meter for the new container of test strips. Alternatively, the system may include an auto-calibration system where data is provided individually on each individual test medium in a form readable by the test meter. The carried data may include an embedded code relating to data particular to that individual strip. The data is presented so as to be read by a meter associated with the diagnostic test strip in order to avoid manually inputting the information. In addition, the system may further provide mechanisms to reconfigure the meter to perform a new function when it has been determined that a triggering event has occurred.

Abstract: A system for diagnostic testing may include a meter for performing a diagnostic test on a sample applied to a test media and a container configured to contain test media compatible with the meter. The meter may include a closure portion for selectively closing the opening of the container. The system may further provide a sampling device, such as a lancet, operable connected to the container such that that a user may use the sampling device to obtain a sample without disconnecting the sampling device from the container. The system may also provide mechanisms for removing a meter from a test container and reattaching it to a new one using one of several coding methods that recalibrate the meter for the new container of test strips. In addition, the system may further provide mechanisms to reconfigure the meter to perform a new function when it has been determined that the triggering event has occurred.

Abstract: A medical diagnostic testing device is provided with a voice message capability to record one or more voice messages associated with a test result. When a stored test result is retrieved and displayed, the medical diagnostic testing device also plays the one or more recorded voice messages associated with the stored test result.

Abstract: A system for diagnostic testing may include a meter for performing a diagnostic test on a sample applied to a test media and a container configured to contain test media compatible with the meter. The meter may include a closure portion for selectively closing the opening of the container. The system may further provide a sampling device, such as a lancet, operable connected to the container such that that a user may use the sampling device to obtain a sample without disconnecting the sampling device from the container. The system may also provide mechanisms to disable a power source, an auto-on function of the meter, a diagnostic testing function of the meter, or other function of the meter when it has been determined that a triggering event has occurred. The triggering event may be, e.g., the expiration of a certain time period, passage of a certain date, performance of a certain quantity of diagnostic tests, or use of a certain quantity of test media.

Abstract: A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the sample chamber. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.

Abstract: An optical system which may be a component of apparatus for assaying a fluid sample with radiation is capable of exciting fluorescence in fluorescent material and includes a totally internally reflecting, unitary elongated substrate transmissive to both the excitation radiation and to the fluorescence. The fluorescent material includes at least a moiety of an antibody-antigen complex that includes a tag that will provide the fluorescence when excited by an evanescent wave generated by the excitation radiation. The substrate includes an elongated fiber and an integral lens formed to guide the optical radiation into the fiber within the bounds of a critical angle to assure total internal reflectance. A hollow elongated enclosure is disposed concentrically about and spaced from the fiber so as to provide an interspace of capillary dimensions.