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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.

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For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. The control is used for monitoring accuracy or precision for manual techniques and assays from Roche on automated clinical chemistry analyzers.

Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal Plus Control Sera is a two level quality control product prepared from lyophilized human serum with addition of constituent analytes as required to obtain normal and pathological levels.

The provided text describes a 510(k) summary for a new medical device, Precinorm® Universal Plus and Precipath® Universal Plus Control Sera, which are quality control products for in vitro diagnostics. The summary focuses on establishing substantial equivalence to a predicate device.

However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria. The 510(k) summary primarily compares the new device to a predicate device to demonstrate substantial equivalence, rather than detailing performance against acceptance criteria in a study.

Here's an analysis of why the requested information is absent from the provided text:

• Acceptance Criteria and Reported Device Performance (Table 1): The document presents a comparison of characteristics between the modified device and the predicate device, including intended use, format, and levels, and stability. It does not define specific, quantitative analytical acceptance criteria (e.g., specific ranges for accuracy, precision, or recovery for each analyte) that the new device must meet, nor does it present "reported device performance" against such criteria. The "differences" section only lists additional analytes for which values are included in the new device, not performance benchmarks.

• Sample Size and Data Provenance (Table 2): There is no mention of a test set, sample sizes used, or data provenance (country of origin, retrospective/prospective). The document focuses on the product characterization rather than a clinical or analytical study with a defined test set.

• Number and Qualifications of Experts for Ground Truth (Table 3): Since no ground truth establishment for a test set is discussed, there is no information about experts or their qualifications.

• Adjudication Method (Table 4): No adjudication method is mentioned as there's no data requiring adjudication.

• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study (Table 5): This type of study is relevant for imaging or diagnostic interpretation devices. The Precinorm® and Precipath® control sera are quality control products, not diagnostic interpretation algorithms. Therefore, an MRMC study is not applicable and not mentioned.

• Standalone Performance (Table 6): Standalone performance, typically referring to algorithm-only performance, is not applicable to quality control sera. The document describes the characteristics of the control sera themselves, not an algorithm's performance.

• Type of Ground Truth (Table 7): As there is no study evaluating diagnostic accuracy or similar, there is no mention of the type of ground truth used.

• Sample Size for Training Set (Table 8): This device is a control serum, not an AI or machine learning algorithm that requires a training set. Hence, no training set sample size is provided.

• How Ground Truth for Training Set was Established (Table 9): Not applicable for the same reason as above.

In summary, the provided 510(k) summary is for a quality control product and focuses on demonstrating substantial equivalence to a predicate device based on product characteristics and indications for use. It does not contain the detailed study information regarding acceptance criteria, test sets, ground truth establishment, or clinical performance studies that would be expected for a diagnostic device or AI algorithm.

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