(115 days)
The Diazyme high sensitivity C-reactive protein (hsCRP) POC Test Kit is for the in vitro quantitative determination of C-reactive protein (CRP) in human venous whole blood on SMART analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only.
The Diazyme hsCRP POC control set is intended for use as quality controls for the Diazyme hsCRP POC Test Kit. For in vitro diagnostic use only.
Diazyme's hsCRP POC Test Kit is based on a latex enhanced immunoturbidimetric assay on Diazyme's SMART analyzer. Agglutination occurs when an antigen-antibody reaction occurs between CRP in a sample and anti-CRP which has been sensitized to latex particles. This agglutination is detected as an absorbance change (700 nm), with the magnitude of the change being proportional to the quantity of CRP in the sample. The instrument calculates the CRP concentration of patient specimen by use of a lot specific calibration curve that is stored in an RFID card provided with each hsCRP POC kit. The RFID card is inserted in the SMART analyzer and is needed for every single run.
Diazyme hsCRP POC Control Kit is intended for use as quality controls for the Diazyme hsCRP POC Test Kit and is packaged separately. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. OC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If OC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists.
SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.
The Diazyme hsCRP POC Test Kit system thus consists of the following:
- hsCRP POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and . cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
- hsCRP POC Control Kit. Controls are provided for quality control of the . hsCRP POC Assay.
Equipment needed for Diazyme hsCRP POC Test Kit:
• SMART Analyzer (K092911).
Kit components
(Candidate device)
Reagent 1
40 DRS cuvette (prefilled)
- · 100 mM TrisCl buffer
Reagent 2
40 DRS caps (prefilled)
- Suspension of anti-human CRP polyclonal antibody coated latex particles . (
The document describes the Diazyme hsCRP POC Test Kit, an in vitro diagnostic device for quantitative determination of C-reactive protein (CRP) in human venous whole blood. The device is intended for the detection and evaluation of inflammatory disorders, associated diseases, infection, and tissue injury.
Here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines several performance tests with specific acceptance criteria and the observed results.
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision (Internal) | Within-run and total CV% (specific values not explicitly stated, but generally low for diagnostic devices) | Within Run CV%: |
- 0.813 mg/L: 9.62%
- 3.186 mg/L: 2.83%
- 12.560 mg/L: 1.79%
Total Precision CV%: - 0.813 mg/L: 8.17%
- 3.186 mg/L: 3.09%
- 12.560 mg/L: 2.12% |
| Precision (External) | Within-run and total CV% (specific values not explicitly stated, but generally low for diagnostic devices) | Within Run CV% (POL sites): - 0.798 mg/L: 4.67%
- 4.796 mg/L: 7.02%
- 0.758 mg/L: 9.04%
- 17.796 mg/L: 4.18%
- 7.780 mg/L: 5.43%
- 18.725 mg/L: 5.02%
Total CV% (POL sites): - 0.798 mg/L: 8.58%
- 4.796 mg/L: 7.37%
- 0.758 mg/L: 8.13%
- 17.796 mg/L: 4.02%
- 7.780 mg/L: 5.24%
- 18.752 mg/L: 4.78% |
| Linearity | (Implicitly to support AMR) | Linearity data and LOQ data support Analytical Measuring Range (AMR) of 0.47 mg/L to 23.0 mg/L. |
| Limit of Detection (LOD) | (Implicitly to determine lower detection limit) | LOD is 0.15 mg/L |
| Limit of Quantitation (LOQ) | (Implicitly to determine lower quantitation limit) | LOQ is 0.47 mg/L |
| Analytical Specificity (Interference) |
§ 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).