(73 days)
High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent, when used in conjunction with IMMAGE® 800 Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of C-Reactive protein in human serum or plasma by rate turbidimetry.
Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated for use as an aid in the identification and stratification of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome.
CAL 5 Plus (Calibrator 5 Plus), when used in conjunction with Beckman Coulter reagents, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of Anti-Streptolysin O (ASO), C-Reactive Protein (CRP) and Rheumatoid Factor (RF).
High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent is intended for the quantitative determination of C-Reactive protein in human serum or plasma by rate turbidimetry. The IMMAGE® 800 Immunochemistry Systems CCRP reagent is based on the highly sensitive Near Infrared Particle Immunoassay rate methodology. An anti-CRP antibody-coated particle binds to CRP in the patient sample resulting in the formation of insoluble aggregates causing turbidity. The rate of aggregate formation is directly proportional to the concentration of CRP in the sample.
CAL 5 Plus (Calibrator 5 Plus) is a frozen liquid serum matrix intended for use on IMMAGE® Immunochemistry Systems for the calibration of Anti-Streptolysin O (ASO), C-Reactive Protein (CRP) and Rheumatoid Factor (RF).
Here's a breakdown of the acceptance criteria and study information for the Immage® 800 Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) Reagent, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format for method comparison, linearity, or imprecision (e.g., "slope must be between X and Y"). However, it presents the results of these studies, and the FDA's decision to grant substantial equivalence implies that these results met their internal criteria for acceptance.
For the purpose of this analysis, I will infer the implicit acceptance criteria from the context of standard analytical performance requirements for diagnostic devices and the successful outcome of the 510(k) submission.
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance (Immage® High Sensitivity Cardiac CCRP Reagent) |
|---|---|---|
| Method Comparison | ||
| Slope (vs. Predicate) | Close to 1.0 | 0.965 (0.2 to 60 mg/L) |
| 1.013 (0.2 to 10 mg/L) | ||
| Intercept (vs. Predicate) | Close to 0 | 0.334 (0.2 to 60 mg/L) |
| -0.026 (0.2 to 10 mg/L) | ||
| R (Correlation Coefficient) | Close to 1.0 | 0.9962 (0.2 to 60 mg/L) |
| 0.9939 (0.2 to 10 mg/L) | ||
| Imprecision (Within-Run) | %CV typically |
§ 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).