Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls 1/2
by Instrumentation Laboratory CO
510(k) K032663
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032663 | Date19 Dec 2003 | StatusActive |
Official records
- FDA 510(k) database K032663
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Quantex Crp High Sensitivity Standard Multipoint, Quantex Crp High Sensitivity Controls Ve Controls 1/2
- 510(k) Number
- FDA product code
- DCK
- Device class
- Class II
- Regulation
- 21 CFR Part 866.5270
- Advisory committee
- Immunology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Quantex CRP High Sensitivity Standard Multipoint and Controls 1/2 are C-Reactive Protein (CRP) antigen, antiserum, and control reagents designed for use in immunology assays. These devices are intended for quantitative measurement of high-sensitivity CRP levels in serum or plasma via turbidimetric analysis, enabling detection of low concentrations associated with inflammatory or cardiovascular risk assessment.
Supplied as liquid controls and multipoint standards, these reagents are intended for in vitro diagnostic use in clinical laboratories. The Quantex CRP High Sensitivity Standard Multipoint establishes calibration curves, while the Controls 1/2 verify assay performance. Both are single-use, non-sterile, and require storage at 2–8°C. The device holds FDA 510(k) clearance (K032663) under product code DCK, classified as Class II with Special Controls.