(34 days)
Precinorm PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precipath PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
The Precinorm PUC and Precipath PUC Controls consist of a buffered aqueous solution with biological materials added as required to obtain desired component levels in either the normal or pathological range. Values for constituent analytes are provided in product labeling.
The provided text describes a 510(k) submission for the "Precinorm PUC and Precipath PUC Controls" and focuses on establishing substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria.
The 510(k) summary primarily compares the new device to a predicate device (Roche Diagnostic Precinorm Protein Precipath Protein Controls, K981401) in terms of:
- Intended Use: Both are for quality control by monitoring accuracy and precision for quantitative methods. The key difference is that the new device specifies "Proteins in Urine/CSF," while the predicate specifies "serum proteins."
- Format: Both are liquid, ready-for-use controls with concentrations adjusted to represent normal and pathological ranges. The new device is a buffered aqueous solution, while the predicate is based on human serum.
- Stability: Stated as "Same" for the new device, with the predicate's stability detailed (unopened: stable at 2-8°C until expiration; opened: stable for 4 weeks at 2-8°C).
- Matrix: The new device uses a buffered aqueous solution, while the predicate uses stabilized human serum.
- Constituent Analytes: There are significant differences in the specific analytes listed for each device. The new device lists Albumin, Creatinine, Total Protein, and Urine/CSF Protein. The predicate device lists a much broader range of serum proteins.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because such details are not present in the provided text.
The document is a regulatory submission for substantial equivalence, which primarily involves comparing a new device to an already legally marketed predicate device to demonstrate that it is as safe and effective. It does not detail specific performance studies with acceptance criteria in the manner one might find for a novel diagnostic algorithm or drug.
§ 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.