DGTX Flex Reagent Cartridge, Model DF36
by Dade Behring, Inc. 510(k)
Active
510(k) K990251
Overview
The DGTX Flex Reagent Cartridge, Model DF36, is an enzyme immunoassay device designed for the quantitative measurement of digitoxin in human serum and plasma. Classified as a Class II medical device under FDA regulations, it is intended for use in clinical toxicology applications. This cartridge operates within the Dimension® clinical chemistry system to provide accurate digitoxin levels, aiding in the diagnosis of overdose and therapeutic monitoring.
This single-use reagent cartridge is supplied sterile and intended for in vitro diagnostic use. It requires no special storage conditions beyond standard laboratory practices and is compatible with the Dimension® system. The device holds an FDA 510(k) clearance (K990251) under the regulatory category 862.3300, with no third-party involvement. No MRI safety information or reusable specifications are provided in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990251 | Date31 Mar 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LFM
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3300
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What is the DGTX Flex Reagent Cartridge, Model DF36, used for?
The DGTX Flex Reagent Cartridge, Model DF36, is an enzyme immunoassay device designed specifically for the quantitative measurement of digitoxin levels in human serum and plasma. It aids clinicians in diagnosing digitoxin overdoses and monitoring therapeutic levels, ensuring accurate toxicology assessments in clinical settings.
How is the DGTX Flex Reagent Cartridge, Model DF36, supplied and stored?
The cartridge is supplied sterile and intended for single-use only. No special storage conditions are required beyond standard laboratory practices, meaning it can be stored under typical lab environments until use. Always follow manufacturer guidelines for handling and expiration.
Is the DGTX Flex Reagent Cartridge, Model DF36, compatible with any other systems?
The cartridge is designed exclusively for use within the Dimension® clinical chemistry system. It is not compatible with other systems or platforms, so compatibility must be confirmed with the Dimension® system before use.
What regulatory clearance does the DGTX Flex Reagent Cartridge, Model DF36, hold?
The cartridge holds an FDA 510(k) clearance under the regulatory category 862.3300, with a clearance number of K990251. This clearance confirms its substantial equivalence to a predicate device and its suitability for in vitro diagnostic use in clinical toxicology applications.
Can the DGTX Flex Reagent Cartridge, Model DF36, be reused?
No, the cartridge is intended for single-use only. Reusing it could compromise accuracy, sterility, and patient safety. Always adhere to the manufacturer’s instructions for proper disposal after a single use.