(54 days)
For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Reagent is used to quantitatively measure C-reactive protein (CRP) in human serum and plasma. CRP is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with values of CRP that exceed 3 mg/L.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.
For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Performance Verifiers are assayed controls used to monitor performance of hsCRP Reagent on VITROS 5,1 FS Chemistry Systems.
The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS Chemistry System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
- The VITROS 5.1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents.
- The VITROS Chemistry Products range of MicroTip assays, in this case the VITROS Chemistry Products hsCRP Reagent, VITROS Chemistry Products Calibrator Kit 17, VITROS Chemistry Products FS Calibrator 1, and the VITROS Chemistry Products hsCRP Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS hsCRP assay.
- The VITROS Chemistry Products Thin Film range of products, which are dry, multilayered, analytical elements, coated on polyester supports.
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
Here's an analysis of the provided text regarding the VITROS Chemistry Products hsCRP Reagent and related components, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria and then proving the device meets them with specific values in a separate study.
Instead, the summary reports results from a "correlation study" comparing the new device to the predicate. The stated goal for regulatory approval is "substantial equivalence."
| Acceptance Criteria (Implied from Correlation Study) | Reported Device Performance (vs. Predicate) |
|---|---|
| Correlation with Predicate Device: A strong linear relationship with the predicate device, evidenced by a high correlation coefficient and a slope close to 1 with a small y-intercept. | Correlation Coefficient: 0.993 |
| Linear Regression Equation: VITROS hsCRP assay = 0.954 X + 0.063 mg/L (where X is the predicate device) | |
| Additional Performance Characteristics: Acceptable precision, expected values, linearity, and specificity. | Studies were performed to determine precision, expected values, linearity, and specificity. (Details are referenced as being in the Instructions for Use, but not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "patient samples" were used for the equivalence study, but does not specify the exact number of samples used for the correlation with the predicate device.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" in this context is established by the measurements of the predicate device and the new device, not by expert consensus on visual assessment or diagnostic interpretation. This is a quantitative chemical assay, where "truth" is measured by the concentration of C-reactive protein.
4. Adjudication Method for the Test Set
This is not applicable as the study is a comparative quantitative measurement against a predicate device, not an interpretation task requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for image-based diagnostic aids where human readers interpret medical images. The device in question is an in-vitro diagnostic assay for C-reactive protein (CRP) measurement.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the primary study effectively functions as a standalone performance assessment. The comparison is between the new VITROS hsCRP assay (algorithm/device only) and the predicate N High Sensitivity CRP assay (device only). There is no "human-in-the-loop" component in the direct measurement comparison presented.
7. The Type of Ground Truth Used
The "ground truth" for the comparison study was effectively the measurements provided by the legally marketed predicate device (N High Sensitivity CRP assay). The new device's measurements were compared against these predicate measurements to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not provided in the summary. For an IVD assay, "training set" might refer to samples used during the development and optimization of the assay's reagents and calibration parameters. However, the document does not detail this.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the summary. Similar to point 8, if a "training set" was used during development, the ground truth would likely have been established through a highly accurate reference method or a carefully characterized set of control materials.
§ 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).