(486 days)
For in vitro diagnostic use only. Rx Only.
VITROS Chemistry Products hsCRP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure C-reactive protein (CRP) in human serum and plasma. CRP is used to evaluate conditions thought to be associated with inflammation in otherwise healthy individuals.
The quantitative measurement of C-reactive protein (CRP) is performed using the VITROS Chemistry Products hsCRP Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products FS Calibrator 1 on the VITROS 5,1 FS/4600 Chemistry System and the VITROS 5600 Integrated System. The VITROS Chemistry Products hsCRP Reagent is a dual chambered package containing ready-to-use liquid reagents. Samples, calibrators and controls are mixed with Reagent 1 containing a buffer. Addition of anti-CRP antibodies coupled to latex microparticles (Reagent 2) produces an immunochemical reaction yielding CRP antigen/antibody complexes. The turbidity is measured spectrophotometrically at 660 nm. Once a calibration has been performed for each reagent lot, the CRP concentration in each unknown sample can be determined using the stored calibration curve and the measured absorbance obtained in the assay of the sample.
The provided document describes the K160712 510(k) submission for the VITROS Chemistry Products hsCRP Reagent. This is an in vitro diagnostic (IVD) device, not an AI/ML medical device. Therefore, the information regarding acceptance criteria and study design (especially related to human readers, ground truth establishment, and test set/training set specifics) is described through the lens of an IVD device, focusing on analytical performance rather than diagnostic accuracy based on images or clinical data interpreted by AI.
Here's a breakdown of the information provided, tailored to the context of an IVD device:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied/Standard for IVDs) | Reported Device Performance |
|---|---|---|
| Method Comparison | Acceptable correlation with predicate method. | VITROS 5600 vs. Diazyme hsCRP Method: VITROS 5600 = 1.02 x Diazyme hsCRP Method + 0.26 |
| VITROS 4600 vs. VITROS 5600: VITROS 4600 = 1.02 x VITROS 5600 System + 0.01 | ||
| VITROS 5.1 FS vs. VITROS 5600: VITROS 5,1 FS System = 1.07 x VITROS 5600 System + 0.11 | ||
| Demonstrates acceptable correlation. | ||
| Precision | Acceptable %CV and SD at various concentrations. | See "Table 1: Precision study" on page 6. |
| Total %CV ranges from 1.23% to 6.96% across different analyzers, reagent lots, and concentrations. SD is also provided for within-run, between-run, and total precision. | ||
| Assay Range | Clearly defined and clinically relevant range. | 0.34 to 15.00 mg/L |
| Linearity | Linear response across the measuring range. | Linearity found to extend across the measuring range of 0.34 to 15 mg/L. |
| Limits of Blank (LoB) | Specified limit for blank samples. | 0.21 mg/L |
| Limits of Detection (LoD) | Specified limit for detecting analyte. | 0.26 mg/L |
| Limits of Quantitation (LoQ) | Specified limit for reliable quantitation. | 0.34 mg/L |
| Reference Interval | Verified range for healthy individuals. |
§ 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).