Self-contained hand-held test device for single-use
First Claim
1. A self-contained hand-held test device for the single-use determination of an analyte in a bodily fluid sample, the self-contained test device comprising:
- a housing with;
a proximal end;
a distal end; and
a housing cap configured for removable attachment to the distal end of the housing;
a single analytical test strip disposed partially in the housing and extending from the distal end thereof, the single analytical test strip having;
a bodily fluid sample application portion; and
a meter module contact portion;
a meter module disposed in the housing; and
a lancing module attached to the proximal end of the housing and configured to lance a user'"'"'s target site for the expression of a bodily fluid sample, andwherein the single analytical test strip is operably connected to the meter module in a user irreplaceable manner.
5 Assignments
0 Petitions
Accused Products
Abstract
A self-contained hand-held test device for the single-use determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) includes a housing with proximal and distal ends, a housing cap configured for removable attachment to the distal end of the housing, a single analytical test strip (e.g., a single electrochemical-based analytical test strip) disposed partially in the housing and extending from the distal end thereof, a meter module disposed in the housing, and a lancing module attached to the proximal end of the housing. The lancing module is configured to lance a user'"'"'s target site (such as a fingertip or other suitable site) for the expression of a bodily fluid sample. In addition, the single analytical test strip has a bodily fluid sample application portion and a meter module contact portion and is operably connected to the meter module in user irreplaceable manner.
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Citations
22 Claims
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1. A self-contained hand-held test device for the single-use determination of an analyte in a bodily fluid sample, the self-contained test device comprising:
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a housing with; a proximal end; a distal end; and a housing cap configured for removable attachment to the distal end of the housing; a single analytical test strip disposed partially in the housing and extending from the distal end thereof, the single analytical test strip having; a bodily fluid sample application portion; and a meter module contact portion; a meter module disposed in the housing; and a lancing module attached to the proximal end of the housing and configured to lance a user'"'"'s target site for the expression of a bodily fluid sample, and wherein the single analytical test strip is operably connected to the meter module in a user irreplaceable manner. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method for the determination of an analyte in a bodily fluid sample, the method comprising:
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removing a housing cap of a self-contained hand-held test device from a distal end of the self-contained hand-held test device, thus exposing a bodily fluid sample application portion of a single analytical test strip of the self-contained hand-held test device; enabling a lancet module of the self-contained hand-held test device; lancing a target site to express a bodily fluid sample therefrom using a lancet of the lancing module; applying the expressed bodily fluid sample to the bodily fluid sample application portion of the single analytical test strip; measuring an electrochemical response of the single analytical test strip using a meter module of the self-contained hand-held test device; determining, using the meter module, the analyte based on the measured electrochemical response; and discarding the hand-held self-contained test device after a single determining step, wherein the single analytical test strip is operably connected to the meter module in a user irreplaceable manner. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22)
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Specification