CRP (II) Calibrators
by Denka Seiken Co., Ltd. 510(k)
Active
510(k) K030546
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030546 | Date2 Jun 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- JIS
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The CRP (II) Calibrators are liquid reagents classified as primary calibrators for clinical chemistry assays. They serve as reference standards to establish a calibration curve for quantitative measurement of C-reactive protein (CRP) in human serum or plasma samples, enabling accurate assay performance.
These calibrators are supplied as liquid reagents and are intended for use with the CRP-Latex (II)X2 SEIKEN Assay kit, a latex-enhanced turbidimetric immunoassay. They are not sterile or single-use; regulatory submission indicates compliance with FDA 510(k) clearance under the Traditional pathway, with a device classification of Class II. No MRI safety or sterility specifications are provided in the data.
Other devices from Denka Seiken Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the purpose of the CRP (II) Calibrators?
The CRP (II) Calibrators are liquid reference standards used to establish a calibration curve for quantitative measurement of C-reactive protein (CRP) in human serum or plasma samples. They ensure accurate performance of the CRP-Latex (II)X2 SEIKEN Assay kit, a latex-enhanced turbidimetric immunoassay.
How are the CRP (II) Calibrators supplied, and are they sterile?
The CRP (II) Calibrators are supplied as liquid reagents. According to the provided data, they are not sterile and are not intended for direct patient use. They are designed for laboratory use only.
Are the CRP (II) Calibrators single-use or reusable?
The CRP (II) Calibrators are not single-use. They are intended for repeated use in laboratory settings to maintain calibration standards for CRP assays, provided they are stored and handled properly.
What regulatory pathway was followed for the CRP (II) Calibrators?
The CRP (II) Calibrators were cleared under the Traditional 510(k) pathway by the FDA, classified as a Class II medical device. The submission was reviewed by the Clinical Chemistry (CH) Advisory Committee and determined to be substantially equivalent to a predicate device.
Can these calibrators be used with other CRP assay kits?
The CRP (II) Calibrators are specifically designed for use with the CRP-Latex (II)X2 SEIKEN Assay kit. While they may share general principles with other CRP assays, compatibility should be verified by the manufacturer or validated in-house before use with alternative kits.