(19 days)
MAS® / DADE® UA Control is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
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The provided text is a 510(k) premarket notification approval letter for MAS™ UA Control Levels 1, and 2 and DADE® UA Control Levels 1 and 2. This device is a quality control material (assayed and unassayed) for urinalysis testing.
The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML-driven medical device. This type of device is a control material for laboratory tests, not a diagnostic imaging or AI-based diagnostic tool. Therefore, many of the requested categories are not applicable to the information contained within this specific 510(k) letter.
However, I can extract the relevant information that is present:
Device Name:
- MAS™ UA Control Levels 1, and 2
- DADE® UA Control Levels 1 and 2
Regulation Number: 21 CFR 862.1660
Regulation Name: Quality control material (assayed and unassayed)
Regulatory Class: I, reserved
Product Code: JJW
Indications for Use:
"MAS® / DADE® UA Control is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis."
Given the nature of the device (a quality control material), the typical "acceptance criteria" and "study" details requested for AI/ML or imaging devices are not contained in this regulatory document. The approval confirms that the device is substantially equivalent to legally marketed predicate devices, meaning its performance characteristics are comparable and it is safe and effective for its intended use as a quality control. The "reported device performance" would typically refer to the stability, expected ranges, and assay values for various analytes, which are part of the product's technical specifications and IFU, but not detailed in this specific FDA approval letter.
Therefore, many of the requested fields cannot be populated from the provided text.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.