Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121339 FDA 510(k)
- FDA Product Code
- DKZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3100 FDA 510(k)
- Regulation Number
- 862.3100 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests are rapid lateral flow immunoassays designed for the qualitative detection of drugs in human urine. These tests use enzyme immunoassay principles to identify the presence or absence of drug-protein conjugates via a competitive binding mechanism on a membrane, providing a preliminary analytical result.
These single-use, non-sterile devices are intended for use in clinical toxicology settings, such as emergency departments or laboratories. Supplied as dip cards or cassettes, they require a urine sample applied via capillary action to determine drug presence at predefined cutoff levels. The device holds an FDA 510(k) clearance (K121339) under the Clinical Toxicology classification and falls under device class II (DKZ). No third-party review was required.
Frequently asked questions
What types of drug detection can the Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests identify in human urine samples?
The Chemtrue tests use rapid lateral flow immunoassay technology to qualitatively detect a wide range of drugs in human urine, including amphetamines and other substances listed in the FDA’s registration data. These tests employ a competitive binding mechanism to identify the presence or absence of drug-protein conjugates, providing preliminary results for clinical toxicology applications like emergency departments or labs.
Are the Chemtrue Dip Card/Cassette Tests reusable, or are they designed for single-use only?
The Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests are explicitly designed for single-use only. Each device is intended to be used once per urine sample, ensuring accuracy and preventing cross-contamination.
How are the Chemtrue tests supplied, and what is the process for using them?
The tests are supplied as dip cards or cassettes and require a urine sample applied via capillary action. No additional equipment is needed—simply add the urine to the designated area, and the test will visually indicate the presence or absence of drugs within minutes, based on predefined cutoff levels.
Do the Chemtrue tests require sterile handling, or are they non-sterile?
The Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests are non-sterile devices. While they are intended for clinical toxicology settings, they do not require sterile conditions for use, as they are designed for qualitative screening rather than invasive procedures.
What regulatory pathway was followed for FDA clearance of these tests?
The Chemtrue tests received FDA 510(k) clearance (K121339) under the Clinical Toxicology classification, classified as Class II (DKZ). The submission was determined *substantially equivalent* to a predicate device, and no third-party review was required. The clearance was granted through a traditional 510(k) process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Chemtrue Single/Multi-panel Drug Screen Dip Card/Cassette Tests, Chemtrue Single/Multi-panel Drug Screen Dip Card/ Cassette Tests ..., CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS by ..., Chemtrue Single / Multi Drug Screen Cassette / Dip Card Tests
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121339 | Class II | Active |
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Manufacturer
- Manufacturer
- Chemtron Biotech, Inc.
Sources (1)
- FDA 510(k) K121339 24 fields · synced Sep 20, 2026