(12 days)
Precinorm ® U Plus is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath ® U Plus is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precinorm ® U Plus/ Precipath ®U Plus is a quality control product consisting of lyophilized human sera with constituents added as required to obtain desired component levels. Concentrations of control components have been adjusted to represent normal and pathological ranges.
The provided text is a 510(k) summary for the Precinorm® Universal Plus and Precipath® Universal Plus Control Sera. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a predicate device already on the market. It describes the device, its intended use, and compares it to the predicate device.
However, the document DOES NOT contain information about acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document states that the new device is substantially equivalent to the currently marketed Roche Diagnostics Precinorm® U Plus/ Precipath® U Plus (K993360). The focus is on demonstrating that changes to certain characteristics (like stability and the origin of some biological additives) do not alter the substantial equivalence to the previously cleared predicate device.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study to prove they are met because the provided text does not contain this information. The document is a 510(k) summary focused on demonstrating substantial equivalence, not on presenting a study to meet specific performance acceptance criteria for a novel device.
§ 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.