Dimension Tacr Calibrator, Model DC107
by Dade Behring, Inc. 510(k)
Active
510(k) K060503
Overview
The Dimension Tacr Calibrator, Model DC107, is a drug-specific calibrator used as a reference material for the Tacrolimus assay. It consists of a stabilized human whole blood hemolysate containing tacrolimus and is designed to calibrate the Tacrolimus method on the Dimension clinical chemistry system.
This device is supplied for in vitro diagnostic use. It has received FDA 510(k) clearance under the regulation number 862.3200.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060503 | Date18 May 2006 | 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- Withdrawn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
- DLJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3200
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What is the primary purpose of the Dimension Tacr Calibrator DC107?
This device serves as a drug-specific reference material. It is designed to calibrate the Tacrolimus assay specifically when using the Dimension clinical chemistry system.
What is the composition of this calibrator?
The calibrator is formulated as a stabilized human whole blood hemolysate that contains the drug tacrolimus. This matrix is used to ensure accurate measurement during the calibration process.
Is this product intended for clinical use?
Yes, the Dimension Tacr Calibrator is supplied for in vitro diagnostic use. It has received FDA 510(k) clearance under regulation number 862.3200 for use in clinical laboratory settings.