Electronic single use chemical diagnostics device

A self-contained electronic diagnostic device for detecting analytes in biological fluids, comprising:

• a sample inlet area;
• a fluidic structure;
• a fill sensor for detecting a first volume amount of the sample, wherein the device is configured so that the device exits a lower power mode and enters a higher power active mode when the first volume amount is detected, and wherein the device is configured to be disabled if the sample is not added to the device within a threshold amount of time after the device enters an active state;
• an inlet cover configured to cover and uncover the sample inlet area, and wherein the device is configured to activate processing of the sample when the inlet cover covers the inlet area;
• a sample reaction area with one or more detection areas comprising dried reagents;
• a circuit board comprising:
• a single LED light source for illuminating the one or more detection areas;
• and
• one or more optical detectors positioned to receive light reflected from the one or more detection areas, thereby enabling the device to detect one or more analytes;
• a battery for providing power to the device;
• a temperature sensor for measuring temperature;
• a humidity sensor;
• a microcontroller in data communication with the temperature sensor and humidity sensor, and wherein the microcontroller is configured to compare the temperature measured by the temperature sensor with at least one temperature limit and wherein the microcontroller is configured to compare the humidity measured by the humidity sensor with at least one humidity limit;
• wherein the temperature sensor and the humidity sensor and microcontroller are configured to monitor the temperature and humidity from a time of manufacturing of the device until a time of end-use of the device, and wherein the microcontroller is configured to render the device unusable if the microcontroller determines that the measured temperature crosses the temperature limit or the measured humidity crosses the humidity limit;
• wherein the device is configured to operate in the lower power mode during shipment and storage except to exit the lower power mode periodically to measure one or more environmental parameters;
• and
• a near field communication circuit for communicating a quality assessment of the device with an external device.

A self-contained electronic diagnostic device for detecting analytes in biological fluids, comprising:

• a sample inlet area;
• a fluidic structure;
• a fill sensor for detecting a first volume amount of the sample, wherein the device is configured so that the device exits a lower power mode and enters a higher power active mode when the first volume amount is detected, and wherein the device is configured to be disabled if the sample is not added to the device within a threshold amount of time after the device enters an active state;
• an inlet cover configured to cover and uncover the sample inlet area, and wherein the device is configured to activate processing of the sample when the inlet cover covers the inlet area;
• a sample reaction area with one or more detection areas comprising dried or lyophilized reagents;
• a circuit board comprising:
• a single LED light source for illuminating the one or more detection areas;
• and
• one or more optical detectors positioned to receive light reflected from the one or more detection areas, thereby enabling the device to detect one or more analytes;
• a battery for providing power to the device;
• a temperature sensor for measuring temperature;
• a humidity sensor;
• a microcontroller in data communication with the temperature sensor and humidity sensor, and wherein the microcontroller has a time function, and wherein the microcontroller is configured to compare the temperature measured by the temperature sensor with at least two temperature limits, and where the microcontroller is configured to render the device unusable if the device has exceeded a first temperature limit for a first period of time and where the microcontroller is configured to render the device unusable if the device has exceeded a second temperature limit for a second period of time, thereby having a longer shelf life at lower temperatures;
• and wherein the microcontroller is configured to compare the humidity measured by the humidity sensor with at least two humidity limit, and where the microcontroller is configured to render the device unusable if the device has exceeded a first humidity limit for a first period of time and where the microcontroller is configured to render the device unusable if the device has exceeded a second humidity limit for a second period of time, thereby having a longer shelf life at lower humidities;
• wherein the device is configured to operate in the lower power mode during shipment and storage except to exit the lower power mode periodically to measure one or more environmental parameters;
• and
• a near field communication circuit for communicating a quality assessment of the device with an external device.