Provided is an analysis device or an analysis method, by which highly reliable analysis results can be obtained even in the circumstances where environment temperature changes, while reducing load on the user. The analysis device (1) is provided with a determining means (13) which determines whether environmental temperature measured by means of a temperature measuring means (6) is within a predetermined temperature range or not. The determining means (13) is so configured as to determine whether the environmental temperature is within the predetermined temperature range or not, even in the circumstances where information relating to a target substance in a sample cannot be obtained from the analysis device.