(53 days)
CRP-LEX-SYSTEM is intended to be used, in hospital and other The appropriate clinical laboratories, to detect CRP levels in patient serum specimens around the 8ug/ml (0.8mg/d1) concentration.
The CRP-LEX method is by latex slide agglutination. At CRP levels at or above this noted concentration, agglutination of the CRP-LEX, latex particles should be observed. A screening (qualitative) and semi-quantitative procedure (dilution of the patient specimen) has been included and described.
CRP-LEX™ SYSTEM A Latex To Detect C-Reactive Protein In Serum. The CRP-LEX method is by latex slide agglutination.
This document is a marketing authorization letter for the CRP-LEX™ SYSTEM, a device intended to detect C-Reactive Protein (CRP) in serum. It is not a study report, and therefore does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices. It states the "Indications For Use" which describe what the device is intended to do, but not the performance metrics of a specific study.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
- Acceptance Criteria & Reported Performance: The document provides the intended use: "to detect CRP levels in patient serum specimens around the 8ug/ml (0.8mg/d1) concentration" and that "At CRP levels at or above this noted concentration, agglutination of the CRP-LEX, latex particles should be observed." This describes the functionality and threshold for detection, not specific performance metrics like sensitivity, specificity, accuracy, or their acceptance criteria from a validation study.
- Sample Sizes (Test & Training): Not mentioned in this regulatory letter.
- Data Provenance: Not mentioned.
- Number of Experts & Qualifications: Not mentioned.
- Adjudication Method: Not applicable for a device described in this type of letter.
- MRMC Comparative Effectiveness Study: Not mentioned, and generally not applicable for a diagnostic test like this unless comparing it to human readers interpreting raw data (which is not the case for a latex agglutination test).
- Standalone Performance: The described "CRP-LEX method is by latex slide agglutination." The performance of this method is inherent to the device itself. However, the details of its standalone performance (e.g., sensitivity, specificity values) are not provided.
- Type of Ground Truth: The device detects CRP levels. The "ground truth" for a device like this would typically be established by a reference method for CRP quantification, but this is not detailed in this regulatory letter.
- Ground Truth for Training Set: Not mentioned.
In summary, the provided document is a regulatory approval letter based on a 510(k) submission, confirming substantial equivalence. It does not provide the detailed study results and performance metrics that your request asks for. To find that information, one would typically need to consult the 510(k) summary, peer-reviewed publications, or the manufacturer's internal validation reports, which are not included here.
§ 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).