A device and method for performing a diagnostic test, including determining presence or absence of antibodies to a virus. The device displays the results on a display, and includes a retractable needle and an enclosure that houses the retractable needle, a vessel for collecting or storing a bodily liquid sample collected from the subject, an enclosure containing a diluent fluid that is mixed with the collected sample, and at least one area for mixing and performing analysis.

A pressure sensor checks for pressure being applied by the test subject's finger during the test, and stops the test or disables display if it does not sense pressure of the test subject's finger during testing. A processor performs identification testing by scanning a digital fingerprint of the test subject by a digital scanner prior to evaluation, stores the data and evaluates the test results to determine whether the results exceed or reach a threshold value. The testing and evaluation are performed only after a successful identification of the test subject. The device keeps the test information and identification information about the test subject anonymous, and does not communicate the identity of the test subject and the test results to an external device.

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood from subjects. In one aspect, the present invention is directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a substance transfer component (for example, one or more needles or microneedles) and a reduced pressure or vacuum chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some embodiments, the device may contain a “snap dome” or other deformable structure, which may be used, at least in part, to urge or move needles or other suitable substance transfer components into the skin of a subject. In some cases, for example, the device may contain a flexible concave member and a needle mechanically coupled to the flexible concave member such that the needle may be urged or moved into the skin using the flexible concave member. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.

A method and transceiver for calibrating an analyte sensor using one or more reference measurements. In some embodiments, the method may include receiving a first reference analyte measurement (RM1) and determining whether the RM1 is unexpected. In some embodiments, the method may include, if the RM1 was determined to be unexpected, receiving a second reference analyte measurement (RM2). In some embodiments, the method may include determining whether one or more of the RM1 and the RM2 are acceptable as calibration points. In some embodiments, the method may include, if one or more of the RM1 and the RM2 are determined to be acceptable as calibration points, accepting one or more of the RM1 and the RM2 as calibration points. In some embodiments, the method may include calibrating the analyte sensor using at least one or more of the RM1 and the RM2 as calibration points.

Methods and systems for collecting blood samples are described. The disclosed methods and systems employ exposure of the skin surface at a sampling location to electromagnetic radiation, such as blue light, to induce vasodilation in the skin in order to increase a rate of capillary perfusion and blood collection. Following or during the exposure process, the skin at the sampling location can be pricked with one or more lancets to generate capillary perfusion sites for the blood collection process. Following collection of a blood sample, some of the disclosed devices and methods can optionally use heat or infrared electromagnetic radiation to increase a clotting rate to close the capillary perfusion sites.

Methods and systems for collecting blood samples are described. The disclosed methods and systems employ exposure of the skin surface at a sampling location to electromagnetic radiation, such as blue light, to induce vasodilation in the skin in order to increase a rate of capillary perfusion and blood collection. Following or during the exposure process, the skin at the sampling location can be pricked with one or more lancets to generate capillary perfusion sites for the blood collection process. Following collection of a blood sample, some of the disclosed devices and methods can optionally use heat or infrared electromagnetic radiation to increase a clotting rate to close the capillary perfusion sites.

An automated insertion assembly includes a first dermal perforation assembly configured to releasably engage a first subdermal device. A first actuation assembly is configured to drive the first dermal perforation assembly into a user's skin to a first depth and drive the first subdermal device into the user's skin to a second depth. The second depth is greater than the first depth.

Systems, methods, and devices of a health device network may include: a non-invasive glucometer that non-invasively measures analyte levels; an invasive glucometer communicatively coupled directly to the non-invasive glucometer; a cloud-based server communicatively coupled to the non-invasive glucometer or the invasive glucometer; a user device communicatively coupled to the cloud-based server; and/or a user interface that displays the invasive glucose measurement, the non-invasive glucose measurement, a data batch, and/or processed data to the user. The non-invasive glucometer and/or the invasive glucometer may aggregate an invasive glucose measurement and a non-invasive glucose measurement into the data batch. A data analytics application on the cloud-based server may be configured to: integrate the invasive glucose measurement and the non-invasive glucose measurement; identify a correlation between the invasive glucose measurement and the non-invasive glucose measurement; and/or generate a predictive model based on the invasive glucose measurement and the non-invasive glucose measurement.

Systems, methods, and devices of a health device network may include: a non-invasive glucometer that non-invasively measures analyte levels; an invasive glucometer communicatively coupled directly to the non-invasive glucometer; a cloud-based server communicatively coupled to the non-invasive glucometer or the invasive glucometer; a user device communicatively coupled to the cloud-based server; and/or a user interface that displays the invasive glucose measurement, the non-invasive glucose measurement, a data batch, and/or processed data to the user. The non-invasive glucometer and/or the invasive glucometer may aggregate an invasive glucose measurement and a non-invasive glucose measurement into the data batch. A data analytics application on the cloud-based server may be configured to: integrate the invasive glucose measurement and the non-invasive glucose measurement; identify a correlation between the invasive glucose measurement and the non-invasive glucose measurement; and/or generate a predictive model based on the invasive glucose measurement and the non-invasive glucose measurement.

Wearable sensor patches, applicator systems for applying wearable sensor patches, and associated systems, devices, and methods are disclosed herein. In one embodiment, an applicator system includes a first applicator portion, a second applicator portion, a spring, and a trigger mechanism. The first applicator portion releasably retains a wearable sensor patch configured to detect a parameter of an analyte in fluid of a user. When the applicator system is in a loaded mode, the spring and the first applicator portion are positioned within the second applicator portion such that the spring is positioned between the first applicator portion and the second applicator portion. The trigger mechanism is configured to initiate a transition of the applicator system from the loaded mode to a released mode such that the spring accelerates the first applicator portion distally away from the second applicator portion to apply the wearable sensor patch to the user.