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Reagent Strips for Urinalysis (qualitative and semi-quantitative) of Urobilinogen, Glucose, Bilirubin, Ketone (acetoacetic acid), Specific Gravity, Blood, pH, Protein, Nitrite, Leukocytes, and Ascorbic Acid in human urine.

CYBOW 11 Reagent Strips are for single use in professional near-patient (pointof-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas:

• · Kidney function
• · Urinary tract infections
• · Carbohydrate metabolism (e.g. diabetes mellitus)
• · Liver function
• · Acid-base balance
• · Urine concentration

The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually.

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The provided text is a 510(k) clearance letter from the FDA for the CYBOW 11 Reagent Strips for Urinalysis. This document does not contain the acceptance criteria or the study details you are asking for.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which means the FDA did not require new clinical studies for its approval. Instead, the clearance is based on the device demonstrating similar performance characteristics to existing, approved devices.

Therefore, I cannot provide the requested information based on the input text. To answer your questions, one would need to access the actual 510(k) submission document (K052525) and any associated performance data that D.F.I. Co. Ltd. provided to the FDA.

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