Stratus CS TROP CalPak
by Dade Behring, Inc. 510(k)
Active
510(k) K981100
Overview
The Stratus CS TROP CalPak is a secondary calibrator device used in clinical chemistry applications. It is designed to calibrate the Stratus CS system for troponin testing, ensuring accurate measurement of cardiac biomarkers.
This device is supplied as a calibrator pack and is intended for single-use in laboratory settings. It is classified as a Class II medical device with product code JIT and is regulated under FDA 510(k) clearance number K981100. The device is stored according to manufacturer specifications and requires appropriate handling to maintain calibration integrity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981100 | Date16 Apr 1998 | 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- Withdrawn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
- JIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What is the Stratus CS TROP CalPak used for?
The Stratus CS TROP CalPak is a secondary calibrator device specifically designed for calibrating the Stratus CS system to ensure accurate measurement of cardiac biomarkers, particularly troponin, in clinical chemistry applications.
How is the Stratus CS TROP CalPak supplied and is it reusable?
The device is supplied as a calibrator pack and is intended for single-use in laboratory settings. It should not be reused to maintain calibration integrity and ensure accurate test results.
What are the storage requirements for the Stratus CS TROP CalPak?
The Stratus CS TROP CalPak must be stored according to manufacturer specifications to maintain its calibration integrity. Proper handling and storage conditions are essential to ensure the device functions correctly when used.
What is the regulatory classification of the Stratus CS TROP CalPak?
The Stratus CS TROP CalPak is classified as a Class II medical device with product code JIT. It is regulated under FDA 510(k) clearance number K981100, which indicates it is substantially equivalent to other legally marketed devices.