(190 days)
For the quantitative determination of C-reactive protein in human serum and plasma. The C-reactive protein test is used for the detection and assessment of inflammatory disorders, tissue injury and infection. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases.
The C-Reactive Protein US test is a latex particle-enhanced immunoturbidimetric assay packaged for use on the Roche/Hitachi family of analyzers.
Here's an analysis of the provided 510(k) summary for the CRP US Test System based on your request. Please note that the document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about a de novo study to establish new acceptance criteria and prove the device meets them from scratch. It relies on the predicate device's established performance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in the format of a separate section with pass/fail thresholds. Instead, it demonstrates substantial equivalence by comparing features and stating that the performance characteristics were evaluated and found to be equivalent to the predicate device.
However, based on the context of a 510(k) submission, the implicit "acceptance criteria" for the new device (CRP US) are that its performance characteristics are comparable to the legally marketed predicate device (Roche Integra C-Reactive Protein test, K981897).
Therefore, the table below reflects this comparative performance rather than absolute acceptance criteria with specific numerical targets.
| Feature / Performance Characteristic | Acceptance Criteria (Implicit - Equivalent to Predicate) | Reported Device Performance (CRP US) |
|---|---|---|
| Intended Use | Quantitative determination of C-reactive protein | Quantitative determination of C-reactive protein |
| Indication for Use | Detection and assessment of inflammatory disorders, tissue injury and infection | Detection and assessment of inflammatory disorders, tissue injury and infection |
| Sample Type | Human serum and plasma | Human serum and plasma |
| Traceability | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) |
| Assay Principle | Latex particle-enhanced immunoturbidimetric test | Latex particle-enhanced immunoturbidimetric test |
| Instrument Platform | Integra family of analyzers | Roche/Hitachi family of analyzers (This is the primary difference identified) |
| Overall Performance | Equivalent to predicate device | Evaluated and found to be equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the specific data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "performance characteristics...evaluated" without providing specific study details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The nature of the device (in-vitro diagnostic for C-Reactive Protein) typically involves analytical validation against reference methods or established standards rather than expert clinical consensus for "ground truth" in the same way an imaging AI algorithm might.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods are typically used in studies involving human interpretation (e.g., medical imaging) to resolve discrepancies among multiple readers. For an in-vitro diagnostic device like this, performance is assessed through analytical studies using laboratory methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers in tasks like image interpretation, which is not the function of the CRP US Test System.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device itself is a standalone in-vitro diagnostic test. Its performance is evaluated analytically, without a "human-in-the-loop" component in terms of result generation. The results are obtained directly from the analyzer.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the performance of the CRP US Test System would implicitly involve comparison to:
* Reference materials/standards: The document mentions "IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619)" for traceability, indicating an objective, standardized basis for measurement.
* Predicate device results: A key aspect of a 510(k) submission is demonstrating equivalence to a legally marketed predicate. Therefore, the "ground truth" for proving substantial equivalence would largely be the established performance and results from the predicate device through comparative studies.
* Clinical correlation (implied): While not explicitly detailed, the clinical utility of CRP measurement for "detection and assessment of inflammatory disorders, tissue injury and infection" reflects that the results are expected to align with clinical outcomes or physician diagnoses, though this isn't the primary "ground truth" for analytical performance.
8. The Sample Size for the Training Set
This document does not describe a "training set" in the context of machine learning, as the CRP US Test System is a latex particle-enhanced immunoturbidimetric assay, not an AI/ML algorithm. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set was Established
As the device is not an AI/ML algorithm, the concept of a "training set" and establishing its ground truth in that context is not applicable here. The assay's performance is based on its biochemical and analytical principles.
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).