Bodily fluid sample collection systems, devices, and method are provided. The sample is collected at a first location and subjected to a first sample processing step. The sample may be shipped to a second location and subjected to a second sample processing step that does not introduce contaminants into a plasma portion of the sample formed from the first processing step. The sample may also be mixed with other material(s) in the collection device.

The present invention relates to an electronic module for a sample collection device, comprising: a measurement system for measuring a volume of collected fluid of a patient in real time and determining when a predefined amount of fluid has been collected, and means for providing a warning signal to a user when it is determined that the predefined amount of fluid has been collected.

Further, the inventions relates to a system for extracting and collecting a sample of a fluid of a patient.

An applicator device (10) is provided for applying a patch (44) having an array of microprotrusions (90) to the stratum corneum. The applicator device (10) includes a device body (12) and a piston moveable within the device body (12). A cap (16) is provided on the device body (12) for activating the device (10) to impact the stratum corneum with a microprotrusion array (44,90). The device (10) is capable of being cocked by one handed operation of the user which allows the device (10) to be used by patients having neither the strength nor the manual dexterity to cock other types of applicator devices.

Provided is a status monitoring device that includes a one-way valve including a change ring and an activator stem. The change ring is configured to change colors (e.g., red, yellow, green or orange) depending on the status of the medical device in operation. The activator stem attached to an interior opening of the one-way valve and is disposed in a vertical direction to interface with a flow channel within the medical device and come into contact with fluids passing therethrough in order to determine whether the medical device is inserted into and operating properly within a patient's body part (e.g., neck, chest, arms and feet).

Lancet device includes a housing, a removable front cap mounted to the housing, a lancet holding member, and a trigger. A system is utilized for placing the lancet device in a trigger-set or armed position. A depth adjustment system includes a member that is at least partially rotatably mounted and that has an axis of rotation arranged substantially perpendicular to a center axis of the lancet holding member. An ejection system is utilized for at least one of preventing axial movement of the lancet holding member and removing or ejecting a lancet from the lancet holding member.

Sample processing methods and systems to collect a biological sample. A device may be configured collect a predetermined volume of a sample in sample chamber and seal the chamber upon activation. The device may be further configured to mix the mix the sample with a predetermined volume of a reagent and/or mix the sample and the reagent in a pre-determined ratio.

Disclosed is a puncturing system for generating a puncture wound for obtaining a sample of a body fluid, comprising a press-on part to be pressed onto a body part in which a puncture wound is to be generated, a trigger, by the actuation of which a user can trigger a puncturing motion of a puncturing element after the press-on part is pressed on, and a testing facility for determining at least one test parameter on which a sample-obtaining probability depends. A securing facility is also provided that, in a locked state, locks the trigger such that no puncturing motion can be triggered, and, in a triggering state, releases the trigger such that a puncturing motion can be triggered by actuation thereof, whereby the securing facility is transitioned from the locked state to the triggering state by the testing facility when the test parameter determined by the testing facility meets defined minimum requirements. A signaling facility is also provided for signaling a transition of the securing facility to the triggering state and/or for signaling that the securing facility is in the triggering state. Also disclosed is a method for preparing a puncturing system for generating a puncture wound.

A testing system configured to determine an analyte concentration has a user interface that includes a number of visual indicators on its exterior housing. The visual indicators convey different types of information to a user of the testing system when illuminated. Additionally, the indicators are independent of one another in that they can each be illuminated in different colors from one other and turn on and/or off independently of one another. Further, the visual indicators are illuminated using a common lighting element (e.g., a single light emitting diode (LED)) in combination with one or more waveguides and one or more filters located inside the testing system.

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member.