Creatine Kinase (CK) Test Item #65411
by Em Diagnostic Systems, Inc.
510(k) K924704
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924704 | Date13 Oct 1992 | 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- Withdrawn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
- 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
Overview
AI-generated summary, 23 Sep 2026
This device is a clinical chemistry test item used for the qualitative or quantitative determination of creatine kinase (CK) activity in biological samples. It operates based on the enzymatic conversion of creatine and adenosine triphosphate to phosphocreatine and adenosine diphosphate, with subsequent detection of the reaction products to assess CK levels. The test is intended for use in clinical laboratory settings to aid in the diagnosis and monitoring of conditions associated with elevated CK activity.
The device is supplied as a test item for in vitro diagnostic use and is intended for single-use application under controlled laboratory conditions. It is regulated under the FDA 510(k) premarket notification pathway with reference number K924704 and is classified under product code CGS. Storage conditions and handling requirements are specified by the manufacturer to maintain reagent stability and test performance. The device is not evaluated for MRI compatibility and should be used in accordance with the manufacturer's instructions for optimal accuracy and safety.
Other devices from Em Diagnostic Systems, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the CK Test Item #65411 used for?
The CK Test Item #65411 is used for the qualitative or quantitative determination of creatine kinase activity in biological samples to aid in the diagnosis and monitoring of conditions associated with elevated CK activity.
Is the CK Test Item #65411 for single-use or reuse?
The CK Test Item #65411 is intended for single-use application under controlled laboratory conditions.
How should the CK Test Item #65411 be stored?
The storage conditions and handling requirements for the CK Test Item #65411 are specified by the manufacturer to maintain reagent stability and test performance.
Is the CK Test Item #65411 MRI compatible?
The CK Test Item #65411 is not evaluated for MRI compatibility and should be used in accordance with the manufacturer's instructions for optimal accuracy and safety.