Dade Stratus CK-MB Fluorometric Enzyme Immunoassay
by Dade Intl., Inc. 510(k)
Active
510(k) K972782
Overview
The Dade Stratus CK-MB Fluorometric Enzyme Immunoassay is an in vitro diagnostic test for the MB isoenzyme of creatine kinase. It utilizes fluorometric enzyme immunoassay technology to quantify CK-MB levels in human specimens.
The assay is intended for use in clinical laboratory settings by trained personnel and can be processed on the Stratus® analyzer, Stratus® II analyzer, or Stratus® IIntellect analyzer. It provides quantitative CK-MB concentrations to assist in diagnosing and monitoring myocardial infarction and specific muscle diseases. The device has received FDA 510(k) clearance under K972782 and is classified as a Class II medical device under regulation number 862.1215.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972782 | Date15 Aug 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JHX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1215
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Intl., Inc.
Questions
What is the Dade Stratus CK-MB Fluorometric Enzyme Immunoassay used for?
This is an in vitro diagnostic test designed to quantify the MB isoenzyme of creatine kinase in human specimens. It assists clinicians in diagnosing and monitoring myocardial infarction and specific muscle diseases by providing quantitative CK-MB concentrations.
Which analyzers can process the Dade Stratus CK-MB test?
The assay can be processed on the Stratus® analyzer, Stratus® II analyzer, or Stratus® IIntellect analyzer. It is designed for use in clinical laboratory settings by trained personnel who are familiar with these specific instruments.
What is the regulatory status of the Dade Stratus CK-MB test?
The device has received FDA 510(k) clearance under K972782 and is classified as a Class II medical device under regulation number 862.1215. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.
How is the Dade Stratus CK-MB test supplied and stored?
The device is supplied as a complete in vitro diagnostic test kit containing all necessary components for the fluorometric enzyme immunoassay. While specific storage conditions aren't detailed in the provided information, standard laboratory protocols for immunoassay kits typically recommend storage at controlled room temperature unless otherwise specified by the manufacturer.