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Teco Diagnostics Microalbumin 2-1 combo Strip is designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine.

Microalbuminuria, an abnormal elevation of the urinary albumin excretion rate, is many times one of the first signs of renal diseases and renal damage that can lead to renal failure.

Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

The Teco Microalbumin 2-1 Combo Strips are read by visual comparing color chart.

Teco Microalbumin 2-1 Combo Strips are recommended for use in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.

Teco Microalbumin 2-1 Combo Strips are designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine. The strips are read by visual comparing color chart.

I apologize, but the provided text from the FDA 510(k) letter for the "Teco Microalbumin 2-1 Combo Strips" does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.

This document is primarily a notification of substantial equivalence for a medical device, indicating that the device has been cleared for marketing based on its similarity to existing legally marketed devices. It outlines the regulatory classification, product codes, and general controls applicable to the device.

To fully answer your request, I would need access to the actual 510(k) submission document or a separate study report, which is not included in the provided text. The provided text only confirms the device's clearance and its intended use.

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