Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21
by Branan Medical Corp. 510(k)
Active
510(k) K010734
Overview
The Monitect TCA Drug Screen Test, Models MC21 and MD21, is a Thin Layer Chromatography device designed for the qualitative detection of tricyclic antidepressant (TCA) drugs in biological specimens. It functions as an analytical tool within clinical toxicology to identify the presence of TCAs, aiding in the diagnosis and management of poisoning or overdose cases.
This test is supplied as a cassette-based system intended for single-use in clinical laboratory settings. It requires no sterilisation beyond manufacturer-provided packaging and is classified under FDA 510(k) clearance (K010734) as a Class II device. Models MC21 and MD21 are regulated under FDA regulation number 862.3910 and fall under the product code MLK, with no third-party certification indicated.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010734 | Date30 Jul 2001 | 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- Withdrawn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
- MLK
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3910
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Branan Medical Corp.
Questions
What clinical scenarios is the Monitect TCA Drug Screen Test primarily used for, and how does it help in those situations?
The Monitect TCA Drug Screen Test (Models MC21 and MD21) is designed for clinical toxicology applications, specifically to qualitatively detect tricyclic antidepressant (TCA) drugs in biological specimens. It aids in diagnosing and managing cases of poisoning or overdose by confirming the presence of TCAs, helping clinicians make informed decisions about patient care, such as determining appropriate treatment or countermeasures.
Is the Monitect TCA Drug Screen Test intended for repeated use, or is it a single-use device?
The Monitect TCA Drug Screen Test is supplied as a cassette-based system explicitly intended for single-use in clinical laboratory settings. This design ensures accuracy and safety, as reuse could compromise test integrity and introduce contamination risks.
What are the key differences between the MC21 and MD21 models of the Monitect TCA Drug Screen Test?
The provided data does not specify functional or performance differences between the MC21 and MD21 models beyond their classification as separate variants of the same device. Both are Thin Layer Chromatography tests for detecting TCAs, but further technical distinctions (e.g., sensitivity, sample compatibility) would require consulting the manufacturer’s instructions or labeling.
How is the Monitect TCA Drug Screen Test packaged and stored, and does it require special handling?
The device is supplied in manufacturer-provided packaging that ensures sterility and integrity for single-use. No additional sterilization is required beyond the original packaging. Storage should follow the manufacturer’s guidelines (e.g., protected from extreme temperatures or light), though specific conditions like temperature ranges or shelf life are not detailed in the provided data.
What regulatory pathway does the Monitect TCA Drug Screen Test follow, and how does that affect its use in clinical settings?
The Monitect TCA Drug Screen Test (Models MC21 and MD21) is cleared by the FDA under 510(k) pathway (K010734), classified as a Class II device under regulation 862.3910 and product code MLK. This clearance indicates it meets FDA standards for safety and effectiveness as a qualitative diagnostic tool in clinical toxicology, though its use remains subject to laboratory protocols and professional judgment.