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The Stripmax 1210 Urine Chemistry Analyzer is a semi-automatic urinalysis instrument intended for reading UriMate Reagent Strips for Urinalysis. The tests provided on UriMate Reagent Strips are considered routine urinalysis.

UriMate Reagent Strips for Urinalysis are dip-and-read test strips intended for use as an in vitro diagnostic aid using urine specimens. UriMate Reagent strips provide qualitative and semiquantitative tests for specific gravity, pH, Blood, leukocytes, nitrite, protein, bilirubin, ketone(acetoacetic acid), glucose, and urobilinogen by visual comparison to a color chart or by use of the Stripmax Urine Chemistry Analyzer. The tests provided are considered routine urinalysis.

The Stripmax 1210 Urine Chemistry Analyzer is a semi-automatic urinalysis instrument intended for reading UriMate Reagent Strips for Urinalysis. UriMate Reagent Strips for Urinalysis are dip-and-read test strips intended for use as an in vitro diagnostic aid using urine specimens.

The provided text describes a 510(k) premarket notification for the "Stripmax 1210 Urine Chemistry Analyzer" and "UriMate Reagent Strip for Urinalysis." However, it does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It lists the device name, regulation numbers, classification, product codes, and indications for use.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them based on the provided text. The requested information is simply not present in this regulatory clearance document.

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