(89 days)
The Stratus® CS Acute Care™ CardioPhase® hsCRP method is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
The Stratus® CS Acute Care™ CardioPhase® hsCRP method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology.
The provided text describes a 510(k) summary for the "Stratus® CS Acute Care™ CardioPhase® hsCRP TestPak". This document focuses on demonstrating substantial equivalence to a predicate device for an in vitro diagnostic reagent and is not an AI/ML device.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth for training set) are not applicable or not detailed in the context of an IVD reagent submission for an expanded indication of use (Point of Care settings). The study described is a comparison of performance between laboratory and non-laboratory personnel to support the expanded use.
Here's the information that can be extracted from the provided text, adapted to the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Precision and accuracy data generated by 'non-laboratory' personnel is comparable to precision and accuracy data generated by 'laboratory' personnel." This implies the acceptance criteria was likely "comparability" of performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Precision and Accuracy Data from Non-Laboratory Personnel is Comparable to Laboratory Personnel | Precision and accuracy data generated by "non-laboratory" personnel is comparable to precision and accuracy data generated by "laboratory" personnel. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific test sets but referred to as "Method comparison and precision analyses."
- Data Provenance: The study was conducted at "three different locations (clinical laboratory (LAB), Emergency Department (ED) and Cardiac Care Unit (CCU) within one external evaluation site)." This suggests prospective data collection at these clinical sites. The country of origin is not specified, but the manufacturer is Dade Behring Inc. in Newark, DE (USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This is not applicable to a submission for an in vitro diagnostic reagent where performance is assessed through analytical studies (precision, accuracy, method comparison) rather than expert interpretation of images or other subjective data. The "ground truth" would be the established reference method or comparative device's results.
4. Adjudication Method
Not applicable for an in vitro diagnostic reagent performance study. Results are quantitative measurements compared against a reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not an AI/ML device, so an MRMC study is not applicable. The study involved different operators (laboratory vs. non-laboratory personnel) to assess performance in different settings.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an in vitro diagnostic reagent, not an algorithm. The device itself (reagent and instrument) is a standalone measurement system. The study compares its performance when operated by different types of users (laboratory vs. point-of-care personnel).
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation would be the results obtained by the predicate device (Dade Behring Stratus® CS CardioPhase® hsCRP TestPak, K060369) or a reference method, as the study is a method comparison and precision analysis.
8. The Sample Size for the Training Set
Not applicable. This is an in vitro diagnostic reagent for which performance is analytically validated, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as it is not an AI/ML device requiring a training set.
§ 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).