Method for manufacturing a sterilized and calibrated biosensor-based medical device
First Claim
1. A method for manufacturing a sterilized and calibrated biosensor-based medical device, the method comprising:
- sterilizing at least one biosensor-based medical device that includes a biosensor reagent composition, thereby creating at least one sterilized biosensor-based medical device; and
thereafter, calibrating the biosensor reagent composition of the at least one sterilized biosensor-based medical device.
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Accused Products
Abstract
A method for manufacturing a sterilized and calibrated biosensor-based medical device (e.g., an integrated biosensor and lancet medical device) includes sterilizing a biosensor-based medical device that contains a biosensor reagent composition (e.g., an analyte specific enzyme and mediator biosensor reagent composition). The sterilizing can be accomplished using, for example, a gamma radiation based technique. Thereafter, the biosensor reagent composition of the sterilized biosensor-based medical device is calibrated. Another method for manufacturing a sterilized and calibrated biosensor-based medical device includes first assembling and packaging a plurality of biosensor-based medical devices that include a biosensor reagent composition. The packaged biosensor-based medical devices are then sterilized using a radiation-based sterilization technique, to create a plurality of sterilized, packaged biosensor-based medical devices. Thereafter, the sterilized and packaged biosensor-based medical devices are calibrated. The calibration can be accomplished, for example, using a statistical sample of the plurality of sterilized, packaged biosensor-based medical devices.
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Citations
19 Claims
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1. A method for manufacturing a sterilized and calibrated biosensor-based medical device, the method comprising:
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sterilizing at least one biosensor-based medical device that includes a biosensor reagent composition, thereby creating at least one sterilized biosensor-based medical device; and
thereafter, calibrating the biosensor reagent composition of the at least one sterilized biosensor-based medical device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method for manufacturing a sterilized and calibrated biosensor-based medical device, the method comprising:
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assembling a plurality of biosensor-based medical devices that include a biosensor reagent composition;
packaging the biosensor-based medical devices, thereby creating packaged biosensor-based medical devices;
sterilizing the packaged biosensor-based medical devices using a radiation-based sterilization technique, thereby creating a plurality of sterilized, packaged biosensor-based medical devices; and
thereafter, calibrating the biosensor reagent composition of the sterilized, packaged biosensor-based medical devices. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19)
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Specification