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For the quantitative determination of low levels of albumin in urine. For IN VITRO diagnostic use.

The DCL Microalbumin Assay uses an immunoturbidimetric format which provides the sensitivity required for accurate determination of urinary microalbumin.

The provided text describes a 510(k) premarket notification for a device named "Microalbumin Assay" (Cat. No. 252-2) by Diagnostic Chemicals Limited. This device is intended for the quantitative determination of low levels of albumin in urine for in vitro diagnostic use.

The document does not contain any information regarding acceptance criteria, reported device performance, specific studies demonstrating the device meets acceptance criteria, sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, or details on how ground truth was established for either training or test sets.

The provided text is a standard FDA 510(k) clearance letter and an "Indications for Use" statement. It confirms that the FDA has found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It discusses the general medical context of microalbuminuria and the device's technical approach (immunoturbidimetric format).

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or ground truth information based solely on the provided text. This information would typically be found in the 510(k) submission itself, in a separate study report, or a detailed technical manual, none of which are included in the given document.

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