EMIT C-Reactive Protein Assay
by Syva Co. 510(k)
Active
510(k) K821413
Overview
The EMIT C-Reactive Protein Assay is an enzyme-multiplied immunoassay designed for the quantitative measurement of C-reactive protein (CRP) in human serum or plasma. CRP is a blood protein that rises in response to inflammation, infection, or tissue injury, making this assay useful for monitoring inflammatory conditions and assessing disease activity in clinical settings.
This assay is intended for use in clinical laboratories equipped with appropriate instrumentation, such as the EMIT system. Supplied as a reagent kit, it requires no sterilization as it is designed for single-use per test. The device is classified under FDA 510(k) clearance (K821413) with a decision date of May 28, 1982, and falls under product code DCN for C-reactive protein systems. No MRI safety or reusable components are specified in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821413 | Date28 May 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DCN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5270
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the EMIT C-Reactive Protein Assay used for?
The EMIT C-Reactive Protein Assay is designed for the quantitative measurement of C-reactive protein (CRP) in human serum or plasma. CRP levels rise in response to inflammation, infection, or tissue injury, making this assay useful for monitoring inflammatory conditions and assessing disease activity in clinical settings. It helps clinicians evaluate patient responses to treatment and track progression of inflammatory diseases.
How is the EMIT C-Reactive Protein Assay supplied, and is it reusable?
The EMIT C-Reactive Protein Assay is supplied as a reagent kit. It is intended for single-use per test and does not require sterilization. The kit is specifically designed for use with the EMIT system in clinical laboratories, ensuring compatibility and accuracy for quantitative CRP measurements.
Does the EMIT C-Reactive Protein Assay require any special handling or storage?
The EMIT C-Reactive Protein Assay is supplied as a reagent kit for single-use tests, so no special sterilization or reuse procedures are required. While specific storage conditions are not detailed in the regulatory data, reagent kits like this are typically stored at controlled room temperature (15–30°C) away from direct light and moisture to maintain stability and accuracy. Always follow the manufacturer’s instructions for optimal performance.
What type of clinical laboratories can use the EMIT C-Reactive Protein Assay?
The EMIT C-Reactive Protein Assay is intended for use in clinical laboratories equipped with the EMIT system, which is designed for immunoassay testing. Laboratories must ensure they have the appropriate instrumentation and trained personnel to operate the system and interpret results accurately. This assay is classified under FDA product code DCN for C-reactive protein systems.
Is there any regulatory approval or classification for the EMIT C-Reactive Protein Assay?
The EMIT C-Reactive Protein Assay holds FDA 510(k) clearance with the classification of 'Substantially Equivalent' under the Immunology advisory committee. The clearance number is K821413, and the decision date was May 28, 1982. This classification indicates that the device meets regulatory standards for safety and effectiveness as determined by the FDA.