CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
Device Facts
| Record ID | K142044 |
|---|---|
| Device Name | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. |
| Product Code | LCM · CH |
| Decision Date | Aug 25, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K142044 · Aug 25, 2014 | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE | Guangzhou Wondfo Biotech Co., Ltd. | Unaltered clinical urine samples | Clinical urine samples were used to perform a method comparison study against GC/MS to validate the device's performance characteristics. | Method comparison; Clinical samples; Performance validation |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Method comparison study; Retrospective method comparison | Clinical urine samples; Sample Size: 80; Number of Sites: 1 (in-house) | GC/MS | Qualitative detection of Phencyclidine and Methylenedioxymethamphetamine |
Indications for Use
CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine is a rapid test for the qualitative detection of Phencyclidine and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 25ng/mL and 500ng/mL. respectively. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
Device Story
Lateral flow immunochromatographic assay for qualitative detection of Phencyclidine and Methylenedioxymethamphetamine in human urine; competitive binding principle. Device consists of a split sample cup; user immerses absorbent end into urine sample. Capillary action draws urine across membrane pre-coated with drug-protein conjugates and mouse monoclonal anti-drug antibody-dye conjugates. Analyte below cutoff allows antibody-dye to bind to test region (colored line = negative); analyte above cutoff binds antibody-dye, preventing test line formation (no line = positive). Control line confirms proper flow. Used in point-of-care or home settings by lay users or clinicians. Results provide preliminary screening; positive results require confirmation via GC/MS. Assists in identifying potential drug use; clinical judgment required for interpretation.
Clinical Evidence
Bench testing only. Precision studies (25 days, 2 runs/day) confirmed performance across concentrations. Interference testing evaluated 100+ compounds with no interference at 100µg/mL. Specificity/cross-reactivity tested against metabolites. Method comparison against GC/MS performed with 80 clinical samples. Lay-user study (n=260) across three sites demonstrated high agreement with GC/MS (85-100% depending on concentration relative to cutoff).
Technological Characteristics
Lateral flow immunochromatographic assay. Components: mouse monoclonal anti-drug antibody-dye conjugate, fixed drug-protein conjugates, anti-mouse IgG polyclonal antibodies. Form factor: split sample cup. No electronic components; purely chemical/mechanical sensing via capillary action. Stable at 4-30°C for 18 months.
Indications for Use
Indicated for qualitative detection of Phencyclidine (25ng/mL) and Methylenedioxymethamphetamine (500ng/mL) in human urine. Intended for OTC and prescription use in adults.
