125I Quick-MB Test Kit for Quantitation
by Intl. Immunoassay Laboratories, Inc. 510(k)
Active
510(k) K821964
Overview
This device is a Chromatographic Separation, Cpk Isoenzymes test kit, designed for the quantitation of creatine phosphokinase (CPK) isoenzymes using radioactive iodine-125 (125I) labeling. It facilitates the separation and measurement of CPK-MB, a cardiac-specific isoenzyme, to aid in the diagnosis of myocardial infarction or other cardiac conditions by distinguishing between cardiac and skeletal muscle sources of CPK.
The 125I Quick-MB Test Kit is intended for use in clinical chemistry laboratories and requires professional handling. Supplied as a single-use diagnostic kit, it includes all necessary reagents and components for performing the assay. The kit is regulated under FDA 510(k) clearance (K821964) and falls under Regulation 862.1215, with a classification as a Class II device. Storage and handling must comply with radioactive material safety protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821964 | Date22 Jul 1982 | 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- Withdrawn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
- JHT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1215
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Intl. Immunoassay Laboratories, Inc.
Questions
What is the 125I Quick-MB Test Kit used for?
This kit quantifies creatine phosphokinase-MB (CPK-MB) isoenzymes using radioactive iodine-125 labeling. CPK-MB is a cardiac-specific marker, so the test helps distinguish myocardial infarction (heart attack) from skeletal muscle damage by measuring CPK levels in blood samples. It’s specifically designed for clinical chemistry labs to improve diagnostic accuracy in cardiac conditions.
How is the 125I Quick-MB Test Kit supplied, and is it single-use?
The kit is supplied as a complete single-use diagnostic kit, containing all necessary reagents and components for one assay. Single-use ensures sterility and eliminates cross-contamination risks between patients. Each kit is intended for one test cycle only, after which it must be disposed of as radioactive waste.
Does the kit require special handling due to radioactivity?
Yes, the kit contains radioactive iodine-125 (125I), so it must be handled according to strict radioactive material safety protocols. Users must follow established laboratory procedures for storage, disposal, and exposure minimization. Training in radioactive material handling is mandatory for personnel performing the test.
Is this kit regulated by the FDA, and what classification does it hold?
The 125I Quick-MB Test Kit is regulated under FDA 510(k) clearance (K821964) and classified as a Class II device under regulation 862.1215. This classification indicates it poses moderate risk and requires compliance with specific performance standards to ensure safety and effectiveness in clinical use.
What safety considerations apply to storage and disposal?
The kit must be stored in a secure, radiation-shielded area with restricted access to authorized personnel only. Storage conditions should comply with local radioactive material regulations, including temperature and humidity controls where applicable. After use, all components must be disposed of as radioactive waste following established protocols to prevent environmental contamination and ensure worker safety.