Creatine Kinase (Colorimetric Method)
510(k) K880178
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880178 | Date18 Feb 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JHY
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1215
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a creatine kinase (CK) test system classified under the colorimetric method for measuring enzyme activity. It is designed to quantify creatine phosphokinase (CPK) or its isoenzymes in plasma and serum, aiding in clinical chemistry diagnostics. The colorimetric approach relies on a chemical reaction producing a measurable color change proportional to enzyme activity, enabling precise quantification. Such assays are critical for assessing cardiac and muscle tissue damage, as elevated CK levels often indicate conditions like myocardial infarction or muscular dystrophy.
The Creatine Kinase (Colorimetric Method) is intended for use in clinical laboratory settings and is supplied as a reagent-based test system requiring manual handling. It is not sterile and is designed for single-use per test kit, with no regulatory indication of MRI compatibility. The device is authorized under FDA 510(k) clearance (K880178) and falls under FDA Product Code JHY, categorized under Clinical Chemistry. Storage and handling must adhere to manufacturer instructions to ensure accuracy and reliability of results.
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Questions
AI-generated answers, 1 Oct 2026
What is the Creatine Kinase (Colorimetric Method) test system used for?
This test system is designed to quantify creatine phosphokinase (CPK) or its isoenzymes in plasma and serum using a colorimetric method. It measures enzyme activity by detecting a color change proportional to CK levels, helping clinicians diagnose conditions like myocardial infarction or muscular dystrophy by identifying tissue damage.
How is the Creatine Kinase (Colorimetric Method) test system supplied and used?
The system is supplied as a reagent-based test kit requiring manual handling in clinical laboratory settings. Each kit is intended for single-use per test, meaning one kit is used for one measurement. The test involves adding reagents to the sample and observing the colorimetric reaction to determine enzyme activity.
Is the Creatine Kinase (Colorimetric Method) test system sterile?
No, the Creatine Kinase (Colorimetric Method) test system is not sterile. It is designed for single-use per kit and must be handled according to manufacturer instructions to ensure accurate and reliable results. Sterility is not required for this type of reagent-based diagnostic test.
Can the Creatine Kinase (Colorimetric Method) test system be reused?
No, the test system is explicitly designed for single-use per kit. Reusing the reagents could compromise accuracy, reliability, and potentially introduce contamination, leading to incorrect diagnostic results. Always follow the manufacturer’s guidelines for proper disposal after use.
What storage and handling instructions should be followed for the Creatine Kinase (Colorimetric Method) test system?
The test system must be stored and handled strictly according to the manufacturer’s instructions to maintain the integrity of the reagents and ensure accurate test results. Improper storage, such as exposure to extreme temperatures or light, could degrade the reagents and affect the colorimetric reaction. Always check the packaging for specific storage conditions.