CR3 Keyless Split Sample Cup Morphine - Methamphetamine
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150602 FDA 510(k)
- FDA Product Code
- DNK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3640 FDA 510(k)
- Regulation Number
- 862.3640 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CR3 Keyless Split Sample Cup Morphine - Methamphetamine is a lateral flow immunochromatographic assay device designed for the qualitative detection of morphine and methamphetamine in human urine. It operates via competitive binding, where urine is absorbed into the cup through capillary action and interacts with antibody-dye conjugates to produce a visual result. This device is classified under Thin Layer Chromatography and Clinical Toxicology applications, enabling rapid preliminary screening for drug presence. The test provides a qualitative indication of target substances without quantifying their concentration.
The device is supplied as a single-use, non-sterile lateral flow assay intended for use in clinical toxicology settings, such as emergency departments, forensic laboratories, or drug testing facilities. It requires no external power or specialized equipment beyond standard urine collection procedures. The CR3 Keyless Split Sample Cup is not MRI-safe and must be stored in a dry, temperature-controlled environment as specified by the manufacturer. It holds FDA 510(k) clearance (K150602) under the Traditional 510(k) Review pathway, classified as a Class II device under regulation 862.3640. Results are preliminary and must be confirmed via alternative chemical methods for definitive analysis.
Frequently asked questions
What is the CR3 Keyless Split Sample Cup Morphine - Methamphetamine used for?
This device is designed for the qualitative detection of morphine and methamphetamine in human urine samples. It uses a lateral flow immunochromatographic assay with competitive binding to provide a visual result indicating the presence of these substances. It is intended for preliminary screening in clinical toxicology settings, such as emergency departments or forensic labs, but results must be confirmed with additional chemical testing for definitive analysis.
How is the CR3 Keyless Split Sample Cup supplied and is it sterile?
The device is supplied as a single-use, non-sterile lateral flow assay. It does not require sterilization for its intended purpose, as it is designed for one-time use in controlled environments like clinical toxicology labs. Sterility is not a requirement for this type of qualitative screening test.
Does the CR3 Keyless Split Sample Cup require any special equipment or power?
No, the device operates via capillary action and does not require external power or specialized equipment beyond standard urine collection procedures. It is a portable, self-contained lateral flow assay that produces results visually without instrumentation.
What storage conditions are recommended for the CR3 Keyless Split Sample Cup?
The device must be stored in a dry, temperature-controlled environment as specified by the manufacturer. Avoid exposure to moisture or extreme temperatures, as this could compromise the integrity of the test components. Proper storage ensures accurate and reliable performance.
Are the results from the CR3 Keyless Split Sample Cup definitive, or do they need further confirmation?
The results from this device are preliminary and qualitative only, indicating the presence or absence of morphine and methamphetamine without quantifying concentration. The manufacturer explicitly states that results must be confirmed via alternative chemical methods for definitive analysis, as lateral flow assays are screening tools, not diagnostic.
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: CR3 Keyless Split Sample Cup Morphine - Methamphetamine (K150602) — FDA ..., K151478 FDA 510 (k) - Wondfo CR3 Keyless Split Sample Cup, fda.innolitics.com, CR3 Keyless Split Sample Cup FDA Approval
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150602 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K150602 24 fields · synced Oct 5, 2026