Cobas Creatinine Standards
510(k) K823572
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823572 | Date7 Jan 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Cobas Standards for Creatinine
- 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
Overview
AI-generated summary, 1 Oct 2026
The Cobas Creatinine Standards are reference standards used in clinical chemistry for the quantitative measurement of creatinine levels. These standards are designed for use with colorimetric alkaline picrate assays, a method widely employed in automated clinical analyzers to determine creatinine concentrations in human serum, plasma, and urine. They serve as calibration controls to ensure accurate and reliable assay performance, supporting diagnostic assessments for conditions such as chronic kidney disease.
Supplied as part of the Cobas c systems, these standards are intended for in vitro use in clinical laboratories. They are classified as Class II devices under FDA regulations (21 CFR 862.1225) and were granted FDA 510(k) clearance (K823572) as substantially equivalent to predicate devices. The standards are not described as single-use or reusable in the regulatory data, though their intended use in automated systems implies a controlled, sterile supply for calibration purposes. No MRI safety or storage specifications are detailed in the provided data.
Other devices from Hoffmann-La Roche, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary use of the Cobas Creatinine Standards?
The Cobas Creatinine Standards are designed for quantitative measurement of creatinine levels in human serum, plasma, and urine. They serve as calibration controls for colorimetric alkaline picrate assays, which are commonly used in automated clinical analyzers like the Cobas c systems. This ensures accurate and reliable assay performance, supporting diagnostic evaluations for conditions such as chronic kidney disease.
Are these standards single-use or reusable?
The regulatory data does not explicitly state whether the Cobas Creatinine Standards are single-use or reusable. However, their intended use in automated clinical systems implies they are supplied in a controlled, sterile manner for calibration purposes, which typically aligns with single-use standards to maintain accuracy and prevent contamination.
What type of clinical analyzers are these standards compatible with?
These standards are specifically intended for use with automated clinical analyzers that employ colorimetric alkaline picrate assays. They are part of the Cobas c systems, ensuring compatibility with devices designed for precise creatinine measurement in clinical chemistry laboratories.
Do these standards require any special storage conditions?
The provided data does not specify any particular storage conditions such as temperature or light exposure for the Cobas Creatinine Standards. However, as with most calibration standards, it is generally recommended to store them in a clean, dry environment, protected from contamination and extreme temperatures, to preserve their integrity until use.
What regulatory approvals do these standards hold?
The Cobas Creatinine Standards have been granted FDA 510(k) clearance (K823572) as substantially equivalent to predicate devices. They are classified under FDA regulations as Class II devices (21 CFR 862.1225), indicating they undergo stringent review for safety and effectiveness in clinical chemistry applications.