Synermed Creatinine Reagent Kit
by Synermed, Inc. 510(k)
Active
510(k) K903296
Overview
The Synermed Creatinine Reagent Kit is a diagnostic reagent used for the quantitative determination of creatinine in serum. It employs an alkaline picrate method with a bilirubin-decolorizing compound to measure creatinine levels accurately, ensuring minimal interference from bilirubin. This kit is designed for use in both manual and automated clinical chemistry laboratory procedures.
The kit is supplied as a single-reagent system and is intended for in vitro diagnostic use. It is classified as a Class II device under FDA regulations (862.1225) and has received FDA 510(k) clearance (K903296). The reagent is intended for single-use and must be stored according to manufacturer instructions to maintain stability and performance. No MRI safety information or reusable components are specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903296 | Date17 Aug 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- Withdrawn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
- CGX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1225
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Synermed, Inc.
Questions
What is the Synermed Creatinine Reagent Kit used for?
This kit is designed for the quantitative determination of creatinine levels in serum samples. It employs an alkaline picrate method combined with a bilirubin-decolorizing compound to minimize interference from bilirubin, ensuring accurate results. This makes it suitable for clinical chemistry laboratories performing routine kidney function assessments.
How is the Synermed Creatinine Reagent Kit supplied and intended for use?
The kit is supplied as a single-reagent system, meaning it contains all necessary components for one measurement. It is intended exclusively for in vitro diagnostic use, allowing laboratories to integrate it into both manual and automated clinical chemistry workflows. The reagent is not reusable and must be used once before disposal.
Is the Synermed Creatinine Reagent Kit sterile, and how should it be stored?
The kit is intended for single-use, but sterility is not explicitly stated in the provided data. To maintain stability and performance, it must be stored according to the manufacturer’s instructions, which likely include refrigeration or protection from light and moisture. Always refer to the included documentation for precise storage guidelines.
Can this reagent kit be used in automated clinical chemistry systems?
Yes, the Synermed Creatinine Reagent Kit is explicitly designed for use in both manual and automated clinical chemistry laboratory procedures. Its compatibility with automated systems ensures seamless integration into high-throughput workflows while maintaining accuracy for creatinine measurement.
What regulatory clearance does the Synermed Creatinine Reagent Kit hold?
The kit has received FDA 510(k) clearance under the classification of a Class II device (FDA code 862.1225). This clearance confirms that it meets regulatory standards for safety and effectiveness as a diagnostic reagent for creatinine testing in serum samples.