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A creatinine test system is an in vitro device intended to measure creatinine quantitatively in * serum, plasma or urine. Creatinine measurements are used in the diagnosis and treatment of certain renal functions.

Dual Vial Creatinine Reagent

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Dual Vial Creatinine Reagent." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. However, this document does not contain the specific information requested about acceptance criteria or the study that proves the device meets those criteria.

The clearance letter primarily focuses on:

• Device identification: Dual Vial Creatinine Reagent, K983937, Class II, Product Code: CGX.
• Regulatory status: Substantial equivalence determination.
• General compliance requirements: Annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration.
• Contact information for further regulatory questions.
• Indications for Use: "A creatinine test system is an in vitro device intended to measure creatinine quantitatively in serum, plasma or urine. Creatinine measurements are used in the diagnosis and treatment of certain renal functions."

Therefore, I cannot fulfill your request for details regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, ground truth methods, or MRMC studies based solely on the provided text. These details would typically be found in the 510(k) submission itself (the "notification of intent to market") or a summary of its contents, which is not included here.

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