Raichem Creatine Kinase Reagent, Optimized UV
by Reagents Applications, Inc. 510(k)
Active
510(k) K905084
Overview
The Raichem Creatine Kinase Reagent, Optimized UV is a diagnostic reagent used for measuring creatine kinase (CK) activity via ultraviolet (UV) detection. It falls under the category of NAD Reduction/NADH Oxidation, CPK or Isoenzymes, enabling quantitative analysis of CK levels in clinical chemistry applications. CK assays are commonly employed to monitor cardiac and muscle tissue damage, aiding in the diagnosis of conditions such as myocardial infarction or muscular disorders. The reagent is designed for use in automated clinical chemistry analyzers, ensuring precise and reliable test results.
This reagent is supplied as a liquid for in vitro diagnostic use and is intended for single-use only. It requires storage under controlled conditions, typically refrigerated between 2°C to 8°C, to maintain stability and performance. The device is classified as Class II under FDA regulations and holds an FDA 510(k) clearance (K905084) for substantial equivalence in clinical chemistry applications. No MRI safety or reusable specifications are indicated in the regulatory data. Compliance with 21 CFR 862.1215 ensures adherence to regulatory standards for diagnostic reagents.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905084 | Date20 Dec 1990 | 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- Withdrawn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
- CGS
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1215
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Reagents Applications, Inc.
Questions
What is the Raichem Creatine Kinase Reagent, Optimized UV used for?
The Raichem Creatine Kinase Reagent, Optimized UV is designed for measuring creatine kinase (CK) activity in clinical chemistry applications using ultraviolet (UV) detection. CK assays help diagnose and monitor conditions involving cardiac or muscle tissue damage, such as myocardial infarction or muscular disorders. Its use in automated analyzers ensures reliable and precise test results for clinical decision-making.
How is the Raichem Creatine Kinase Reagent, Optimized UV supplied and intended for use?
This reagent is supplied as a liquid formulation for in vitro diagnostic use. It is intended exclusively for single-use in automated clinical chemistry analyzers. The design ensures consistency and minimizes contamination risks, aligning with best practices for diagnostic testing.
What storage conditions are required for the Raichem Creatine Kinase Reagent, Optimized UV?
To maintain stability and performance, the reagent must be stored under controlled refrigeration between 2°C and 8°C. Proper storage prevents degradation and ensures accurate test results when used within its specified shelf life.
Is the Raichem Creatine Kinase Reagent, Optimized UV reusable or intended for single-use?
The reagent is explicitly intended for single-use only. This design choice aligns with regulatory standards for diagnostic reagents, reducing the risk of cross-contamination and ensuring consistent, reliable performance for each test.
Does the Raichem Creatine Kinase Reagent, Optimized UV have any special regulatory or compliance requirements?
The reagent complies with 21 CFR 862.1215, which governs diagnostic reagents in the United States. It holds an FDA 510(k) clearance (K905084) under the Clinical Chemistry advisory committee, confirming its substantial equivalence to predicate devices for use in automated clinical chemistry analyzers.