Vision Creatine Kinase
by Abbott Laboratories 510(k)
Active
510(k) K883946
Overview
The Vision Creatine Kinase is a diagnostic device classified under Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, used for measuring creatine kinase levels in clinical chemistry. It quantifies creatine kinase isoenzymes, aiding in the diagnosis and monitoring of conditions such as myocardial infarction, muscular dystrophy, and other metabolic disorders. The device operates within the framework of clinical laboratory testing to provide biochemical analysis of patient samples.
This device is supplied as a single-use diagnostic reagent intended for use in clinical chemistry laboratories. It is not intended for MRI environments and must be stored under controlled conditions as specified by the manufacturer. The Vision Creatine Kinase holds an FDA 510(k) clearance (K883946) under the Substantially Equivalent (SESE) designation, with regulatory compliance governed by 21 CFR 862.1215. It is designed for in vitro diagnostic use and adheres to standard laboratory protocols for sample analysis.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883946 | Date13 Oct 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
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 Abbott Laboratories
Questions
What is the Vision Creatine Kinase used for in clinical settings?
The Vision Creatine Kinase diagnostic reagent is designed for measuring creatine kinase isoenzymes in clinical chemistry laboratories. It quantifies these enzymes to assist in diagnosing and monitoring conditions such as myocardial infarction (heart attack), muscular dystrophy, and other metabolic disorders by analyzing biochemical changes in patient samples.
Is the Vision Creatine Kinase reagent single-use or reusable?
The Vision Creatine Kinase is supplied as a single-use diagnostic reagent. This design ensures patient safety and accuracy by preventing cross-contamination between samples, adhering to standard laboratory protocols for in vitro diagnostic use.
What storage conditions are required for the Vision Creatine Kinase?
The device must be stored under controlled conditions as specified by Abbott Laboratories. While exact storage details are not provided, proper handling—such as maintaining appropriate temperature and humidity—is critical to preserve reagent integrity and ensure accurate test results.
Can the Vision Creatine Kinase be used in MRI environments?
No, the Vision Creatine Kinase is explicitly not intended for use in MRI environments. This restriction is likely due to potential interference from magnetic fields or other environmental factors that could compromise reagent performance or safety.
What regulatory approval does the Vision Creatine Kinase hold?
The Vision Creatine Kinase holds FDA 510(k) clearance under the designation *Substantially Equivalent (SESE)*, with clearance number K883946. This classification means it meets regulatory standards for in vitro diagnostic devices under 21 CFR 862.1215, ensuring compliance for clinical chemistry applications.